[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gastrointestinal-endoscopy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gastrointestinal-endoscopy":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,41,77,105,133,159,180,201,225,248],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100651445","phase-4-oliceridine-propofol-dose-for-gastroscope-insertion-in-obese-patients-100651445",false,"NCT07759778","Oliceridine-Propofol Dose for Gastroscope Insertion in Obese Patients","Exploration of the Effective Dose of Oliceridine Combined With Propofol for Gastroscope Insertion in Obese Patients Undergoing Painless Gastrointestinal Endoscopy","Inclusion Criteria:\n\n* 18-65 years old, regardless of sex\n* BMI≥28 kg\u002Fm2\n* The American Society of Anesthesiologists (ASA) has a rating of II-III\n* Plan to undergo elective painless digestive endoscopy\n* The subjects understand the purpose and steps of this experiment, voluntarily participate in this experiment, and sign a written informed consent\n\nExclusion Criteria:\n\n* Known to be allergic to drugs used in the examination process\n* Diagnosed respiratory diseases (asthma, bronchitis, chronic obstructive pulmonary disease, pulmonary embolism, pulmonary edema, lung cancer or upper respiratory tract infection)\n* Cardiovascular diseases (heart failure, unstable angina pectoris, myocardial infarction or arrhythmia) have been diagnosed\n* Current hepatic insufficiency (Child-Pugh grade B or above) or renal insufficiency (estimated glomerular filtration rate \\\u003C 60 ml\u002Fmin\u002F1.73 m2)\n* History of difficult airway (Mallampati Grade IV or expected difficult airway)\n* Long-term use of opioids (regular use of opioids for more than 7 days within 3 months before operation)\n* Pregnant or lactating women\n* Mental illness or cognitive dysfunction can not cooperate","ALL","18 Years","65 Years",{"count":20,"type":21},80,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","The purpose of this study is to find the right dose of two medications, oliceridine and propofol, when used together for sedation in patients with obesity undergoing a painless gastroscope procedure.\n\nCurrently, standard sedation methods using other opioids can sometimes cause breathing problems, especially in patients with obesity. Oliceridine is a newer medication that may provide good pain relief with a lower risk of these side effects. However, the best dose of propofol when combined with oliceridine for this specific patient group is not yet clear.\n\nThis study will enroll patients with obesity (BMI ≥ 28 kg\u002Fm²) who are scheduled for a routine painless gastroscopy. Participants will receive the study medications during their procedure, and the medical team will carefully monitor their vital signs and sedation level. The study aims to find the most effective and safe dose combination to help guide future clinical practice.",[27,28],"Obesity","Gastrointestinal Endoscopy","NOT_YET_RECRUITING","2026-08-11",{"date":32,"type":33},"2026-08-12","ACTUAL",{"date":35,"type":21},"2026-08",{"date":37,"type":21},"2027-06",{"name":39,"class":40},"Lu Yi","OTHER",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":72,"leadSponsor":74,"locationsCount":76},"100651704","therapeutic-effects-of-music-on-procedural-outcomes-100651704","NCT07763860","Therapeutic Effects of Music on Procedural Outcomes","Effect of Intra-Procedural Low-Tempo Instrumental Music Plus Standard Sedation Versus Standard Sedation Alone on Sedative Requirements in Adults Undergoing Gastroscopy and\u002For Colonoscopy: a Single-Center, Parallel-Group, Randomized Superiority Trial With Blinded Outcome Assessors and Statisticians","TEMPO","Inclusion Criteria:\n\n* Age ≥18 years.\n* Scheduled for elective gastroscopy (upper gastrointestinal endoscopy), colonoscopy, or both under procedural sedation.\n* Able to provide written informed consent.\n\nExclusion Criteria:\n\n* Emergency or urgent endoscopic procedure.\n* Hearing impairment that prevents adequate perception of the standardized test audio through the study headphones.\n* American Society of Anesthesiologists (ASA) Physical Status IV or higher.\n* Cognitive impairment, altered mental status, or another condition that prevents provision of informed consent or reliable completion of study assessments.\n* Any condition that prevents safe or appropriate use of the study headphones.",{"count":50,"type":21},180,[52],"NA","This study will evaluate whether listening to low-tempo instrumental music during gastroscopy and\u002For colonoscopy can reduce the amount of sedative medication needed during the procedure. Adults undergoing elective gastroscopy and\u002For colonoscopy with sedation will be randomly assigned to one of two groups. One group will listen to low-tempo instrumental music (60-80 beats per minute) through headphones during the procedure in addition to receiving standard sedation. The other group will receive standard sedation without music.\n\nThe main outcome of the study is the amount of sedative medication required during the procedure. The study will also compare pain after the procedure, time until discharge, patient satisfaction, and changes in heart rate and blood pressure between the two groups. The researchers hypothesize that patients who listen to low-tempo music will require less sedative medication and may have improved recovery and patient-reported outcomes compared with patients receiving standard sedation alone.",[55,28,56],"Procedural Sedation","Music Intervention",[58,59,60,61,55,62,63,64,65,66],"Music","Low-Tempo Music","Gastroscopy","Colonoscopy","Sedation","Propofol","Pain","Patient Satisfaction","Recovery Time","RECRUITING","2026-08-09",{"date":70,"type":33},"2026-08-13",{"date":35,"type":21},{"date":73,"type":21},"2026-10",{"name":75,"class":40},"Bahaa Bou Dargham",1,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":87,"conditions":88,"keywords":89,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":76},"100650586","sed-pack-safety-and-performance-of-a-medical-device-software-for-predictive-monitoring-during-sedation-100650586","NCT07749781","SED Pack: Safety and Performance of a Medical Device Software for Predictive Monitoring During Sedation","Prospective Observational Clinical Investigation to Evaluate the Clinical Performance and Safety of a Medical Device Software (SED Pack) During Standard Procedural Sedation","Inclusion Criteria:\n\n* Age ≥18 years\n* ASA physical status I-III\n* Scheduled for an elective, non-emergent gastrointestinal endoscopic procedure\n* Procedural sedation planned with propofol and remifentanil administered via a target-controlled infusion (TCI) system\n* Administration of sedative and analgesic drugs via a peripheral venous line\n* Ability to understand the study information and provide written informed consent\n\nExclusion Criteria:\n\n* Presence of medical conditions or use of medications that, in the investigator's judgment, could significantly interfere with the interpretation of physiological signals used as reference standards (e.g., severe autonomic dysfunction, severe movement disorders).\n* Known severe neurologic, cardiovascular or respiratory disease that substantially alters baseline physiological monitoring or expected sedation response\n* ASA physical status IV, V or VI\n* Known or anticipated difficult airway requiring advanced airway management or interfering with standard respiratory monitoring\n* Requirement for central venous access for drug administration\n* Sedation performed outside the endoscopy unit (e.g., intensive care, emergency department)\n* Inability to understand study information, provide consent or cooperate with clinical assessments due to language barrier or cognitive impairment",{"count":85,"type":21},120,"OBSERVATIONAL","The SED-PACK study is a prospective, observational, single-center clinical investigation evaluating the clinical performance and safety of SED Pack, a Medical Device Software (MDSW) developed by Predictheon Medical S.L., in a fully blinded, non-interventional setting during routine procedural sedation in adult patients at Hospital Clínic de Barcelona, Spain.\n\nProcedural sedation consists in the administration of sedative and analgesic drugs to allow patients to undergo routine diagnostic or therapeutic procedures comfortably. Despite advances in monitoring technology, adverse events such as arterial hypotension, respiratory depression, or inadequate sedation remain frequent due to marked interindividual variability in drug response. Currently, clinicians rely on standard physiological monitoring that measures what is happening in real time but does not anticipate what is about to happen.\n\nSED Pack is designed to address this gap by continuously processing physiological monitoring data and drug-infusion information to generate four real-time predictive indices (updated once per second): pSED (sedation depth), pNOC (likelihood of response to a noxious stimulus), pHYPO (likelihood of arterial hypotension), and pDEP (likelihood of respiratory depression).\n\nIn this clinical investigation, one hundred and twenty adult patients (≥18 years, ASA I-III) will be enrolled. Predictive performance is evaluated using the c-index for pSED, pHYPO, and pDEP, and AUC-ROC for pNOC. The primary hypothesis is that each index achieves a discrimination performance ≥0.70 (lower bound of the 95% CI also ≥0.70). The software runs in fully blinded mode: its predictions are not visible to clinicians and do not influence patient management. No additional procedures beyond standard clinical care are introduced.\n\nThe study complies with MDR 2017\u002F745 and ISO 14155, with AEMPS authorization and CEIm approval (reference: HCB\u002F2026\u002F0307).\n\nExpected outcomes include confirmation that each SED Pack predictive index achieves clinically acceptable discrimination performance, supporting the clinical use of this investigational software as a tool to anticipate and prevent sedation-related complications.",[55,28],[90,91,92,93,94],"Medical device software","Predictheon","Observational","Non-interventional","Predictive monitoring","2026-08-04",{"date":97,"type":33},"2026-08-06",{"date":99,"type":33},"2026-07-23",{"date":101,"type":21},"2026-12",{"name":103,"class":104},"Predictheon Medical, S.L.","INDUSTRY",{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":18,"maxAge":113,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":116,"briefSummary":117,"conditions":118,"keywords":119,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":129,"leadSponsor":131,"locationsCount":76},"100647320","remimazolam-combined-with-oliceridine-for-sedation-in-elderly-patients-undergoing-gastrointestinal-endoscopy-100647320","NCT07707258","Remimazolam Combined With Oliceridine for Sedation in Elderly Patients Undergoing Gastrointestinal Endoscopy","Hemodynamic and Oxygenation Profiles of Remimazolam Combined With Oliceridine Versus Sufentanil in Elderly Patients Undergoing Painless Gastrointestinal Endoscopy: A Randomized, Double-blind, Controlled Trial","RMZ-OLI-ENDO","Inclusion Criteria:\n\n1. Elderly individuals scheduled to undergo painless gastrointestinal endoscopy.\n2. Age between 65 and 80 years.\n3. Body mass index (BMI) between 18 and 30 kg\u002Fm².\n4. American Society of Anesthesiologists (ASA) physical status I-III (ASA III patients eligible only with mild-to-moderate dysfunction of a single organ system, without severe organ failure, and considered able to tolerate the procedure).\n5. Fried frailty phenotype score \\\u003C 3.\n6. Mini-Mental State Examination (MMSE) score ≥ 27.\n7. Provision of written informed consent by the patient or legal representative.\n\nExclusion Criteria:\n\n1. Allergy or contraindication to remimazolam, oliceridine, or sufentanil.\n2. Liver or renal failure (Child-Pugh class C or eGFR \\\u003C 30 mL\u002Fmin).\n3. Systemic infection, immunosuppression, coagulation disorder, upper gastrointestinal bleeding, or intestinal obstruction.\n4. History of opioid dependence or long-term use of psychotropic drugs.\n5. Difficult airway or severe respiratory dysfunction.\n6. Cognitive impairment, psychiatric disease, or inability to cooperate with assessment.\n7. New York Heart Association (NYHA) functional class III or higher\\[cite: 3\\].\n8. Fried frailty phenotype score ≥ 3.\n9. Use of sedative or analgesic drugs within 24 hours before enrollment.","80 Years",{"count":115,"type":21},240,[52],"This study aims to evaluate the sedative efficacy and safety of remimazolam combined with oliceridine in elderly patients undergoing painless gastrointestinal endoscopy. Elderly patients often face higher risks of respiratory and hemodynamic depression during clinical sedation. This trial will investigate whether the combination of remimazolam and oliceridine can provide stable sedation, maintain stable vital signs, and reduce the incidence of adverse events such as hypoxemia and postoperative cognitive fluctuation in this vulnerable population.",[62,28],[120,121,122,123,55,124],"Remimazolam","Oliceridine","Older Adults","Painless Gastrointestinal Endoscopy","Hypoxemia","2026-07-17",{"date":127,"type":33},"2026-07-21",{"date":125,"type":33},{"date":130,"type":21},"2026-12-01",{"name":132,"class":40},"Baoshan Branch, Renji Hospital, Shanghai Jiao Tong University School of Medicine",{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":141,"sex":16,"minAge":142,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":22,"phases":145,"briefSummary":146,"conditions":147,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":76},"100639580","triton-15-robotic-system-for-diagnostic-colonoscopy-100639580","NCT07606963","Triton 1.5 Robotic System for Diagnostic Colonoscopy","Initial Clinical Experience With the Triton 1.5 Robotic System for Diagnostic Colonoscopy","CARE II","Inclusion Criteria:\n\n1. Age ≥ 22 years\n2. Adults indicated for elective screening, surveillance or diagnostic colonoscopy\n3. Subject is willing and able to provide written informed consent prior to receiving any non-standard of care protocol specific procedures\n4. Subject is willing and able to comply with all protocol required preparation and follow- up visits\n\nExclusion Criteria:\n\n1. Any medical or physical condition\u002Flimitation that would contraindicate a conventional colonoscopy. This assessment will be made by the investigator.\n2. Any active or magnetic implantable medical devices (e.g., pacemakers, defibrillators)\n3. Previous failed colonoscopy (except for inadequate bowel preparation)\n4. BMI \\> 45 kg\u002Fm2\n5. Pregnant participants, women of reproductive potential (pre-menopausal and\u002For no history of hysterectomy), confirmed by a positive pregnancy test (serum).\n6. Surgically altered colonic anatomy\n7. History of colorectal cancer, inflammatory bowel disease, polyposis syndrome, hereditary nonpolyposis colorectal cancer (Lynch) syndrome, sclerosing encapsulating peritonitis, active diverticulitis in last 6 months or toxic megacolon\n8. Lower gastrointestinal bleeding within 28 days prior to the colonoscopy day\n9. Known bleeding tendency such as hemophilia or coagulation factor deficiencies\n10. Subject receiving antiplatelet or anticoagulation therapy apart from low-dose aspirin\n11. Known colonic stricture\n12. Known risk factors for abdominal adhesions such as history of complex abdominal or pelvis surgical procedures, based on investigator assessment\n13. Known abdominal wall hernias\n14. History of radiotherapy to the abdomen or pelvis\n15. History of mesenteric ischemia\n16. Known coronary ischemia or cardiovascular stroke within 3 months prior to the colonoscopy procedure\n17. Contraindication to the proposed sedation \u002F anesthesia\n18. Received any investigational medicine or treatment within 28 days prior to the colonoscopy procedure\n19. Received or planning to receive any other endoscopic procedure within 4 weeks prior and 2 weeks after the colonoscopy procedure\n20. Participation in any concurrent clinical trial that may impact the results of this study\n\nIntra-Operative Criteria:\n\n1. Inadequate bowel preparation, defined as a Boston Bowel Preparation Scale (BBPS) (Appendix A) score \\\u003C 2 in any segment.\n2. Any intraoperative finding or condition that, in the Investigator's judgment, would make study participation unsafe or not in the subject's best interest (e.g., significant stricture, tight sigmoid colon precluding safe overtube passage).",true,"22 Years",{"count":144,"type":21},40,[52],"This study is a prospective, single-arm, non-randomized, single-site study, focused on evaluating the safety and efficacy of the Triton 1.5 System in diagnostic and basic therapeutic colonoscopy.",[61,148,149,28],"Colorectal Cancer Screening","Colorectal Neoplasms","2026-05-18",{"date":152,"type":33},"2026-05-26",{"date":154,"type":21},"2026-08-01",{"date":156,"type":21},"2026-10-15",{"name":158,"class":104},"Neptune Medical",{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":165,"enrollmentInfo":166,"targetDuration":4,"studyType":22,"phases":168,"briefSummary":169,"conditions":170,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":4},"100599029","etomidate-combined-with-propofol-versus-propofol-for-sedation-in-high-altitude-patients-during-gastroscopy-a-randomized-multicenter-clinical-trial-100599029","NCT07079176","Etomidate Combined With Propofol Versus Propofol for Sedation in High-Altitude Patients During Gastroscopy: a Randomized Multicenter Clinical Trial","Inclusion Criteria:\n\nAge: 18 ≤ years ≤ 70 Patients undergoing pain-free gastroscopy or treatment Endoscopy duration within 30 minutes Informed consent obtained from patient or family member\n\nExclusion Criteria:\n\nConcomitant diagnosis of cardiac diseases (e.g., heart failure, angina, myocardial infarction, arrhythmia) Diagnosed pulmonary diseases Liver diseases Kidney diseases Intracranial hypertension ASA class III or higher Concomitant active upper respiratory tract infection","70 Years",{"count":167,"type":21},732,[52],"One of the most common adverse events during sedated gastrointestinal endoscopy is hypoxemia, which can lead to serious consequences. When sedated gastrointestinal endoscopy is performed in high-altitude regions with thin air and lower atmospheric pressure, the risk of hypoxemia in patients significantly increases. Traditionally, propofol is the primary agent for sedation during gastrointestinal endoscopy, offering rapid onset and recovery. However, propofol has many side effects, the most important of which is inhibition of respiration and hypotension. Etomidate has less effect on respiration compared to propofol. But there are also adverse reactions of etomidate such as muscular tremor, nausea and vomiting. This study aims to explore whether the etomidate combined with propofol anesthesia method can reduce the risk of hypoxemia during sedated gastrointestinal endoscopy in high-altitude regions, compared to the traditional propofol anesthesia method .",[28],"2025-07-13",{"date":173,"type":33},"2025-07-22",{"date":175,"type":21},"2025-08-01",{"date":177,"type":21},"2028-04-30",{"name":179,"class":40},"RenJi Hospital",{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":186,"eligibilityCriteria":187,"healthyVolunteers":141,"sex":16,"minAge":142,"maxAge":4,"enrollmentInfo":188,"targetDuration":4,"studyType":22,"phases":190,"briefSummary":191,"conditions":192,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":4},"100588003","robotic-colonoscopy-using-the-triton-40-system-in-adults-for-screening-surveillance-and-diagnosis-of-lower-gastrointestinal-conditions-100588003","NCT06935734","Robotic Colonoscopy Using the Triton 4.0 System in Adults for Screening, Surveillance, and Diagnosis of Lower Gastrointestinal Conditions","Colonoscopy With a Robotic Endoscope, The CARE I Study","CARE I","Inclusion Criteria\n\n1. Age ≥ 22 years\n2. Adults indicated for elective screening, surveillance or diagnostic colonoscopy\n3. Subject is willing and able to provide written informed consent prior to receiving any non-standard of care Clinical Investigation Plan specific procedures\n4. Subject is willing and able to comply with all Clinical Investigation Plan required preparation and follow- up visits -\n\nExclusion Criteria:\n\nInitial Screening \u002F Pre-Operative:\n\n1. Any medical or physical condition\u002Flimitation that would contraindicate a conventional colonoscopy. This assessment will be made by the investigator.\n2. Any active implantable medical devices (e.g., pacemakers, defibrillators)\n3. Previous failed colonoscopy (except for inadequate bowel preparation)\n4. BMI \\> 45 kg\u002Fm2\n5. Pregnant participants, women of reproductive potential (pre-menopausal and\u002For no history of hysterectomy), confirmed by a positive pregnancy test (serum).\n6. Surgically altered colonic anatomy\n7. History of colorectal cancer, inflammatory bowel disease, polyposis syndrome, hereditary nonpolyposis colorectal cancer (Lynch) syndrome, sclerosing encapsulating peritonitis, active diverticulitis in last 6 months or toxic megacolon\n8. Lower gastrointestinal bleeding within 28 days prior to the colonoscopy day\n9. Known bleeding tendency such as hemophilia or coagulation factor deficiencies\n10. Patient receiving antiplatelet or anticoagulation therapy apart from low-dose aspirin\n11. Known colonic stricture\n12. Known risk factors for abdominal adhesions such as history of complex abdominal or pelvis surgical procedures, based on investigator assessment\n13. Known abdominal wall hernias\n14. History of radiotherapy to the abdomen or pelvis\n15. History of mesenteric ischemia\n16. Known coronary ischemia or cardiovascular stroke within 3 months prior to the colonoscopy procedure\n17. Contraindication to the proposed sedation \u002F anesthesia\n18. Received any investigational medicine or treatment within 28 days prior to the colonoscopy procedure\n19. Received or planning to receive any other endoscopic procedure within 4 weeks prior and 2 weeks after the colonoscopy procedure\n20. Participation in any concurrent clinical trial that may impact the results of this study\n\n    Intra-Operative Exclusion Criteria:\n21. Inadequate Bowel Preparation, Boston Bowel Prep Scale Score (after cleansing) \\\u003C 2 in any section\n22. Failed conventional colonoscopy or polypectomy\u002Fbiopsy performed during the conventional colonoscopy procedure in Phase A\n23. Any presenting condition discovered intraoperatively that in the opinion of the investigator would make participating in this study not in the participant's\u002Fpatient's best interest. For example, presence of a stricture or tight sigmoid that would make passing an overtube risky for the patient\n24. Any condition, in the opinion of the Investigator, that is unstable and could jeopardize the safety of the subject and their compliance in the study",{"count":189,"type":21},50,[52],"This study is a prospective, single-arm, non-randomized, single site first-in-human study and will be conducted in two phases, where Phase A will serve to evaluate the safety of the Triton 4.0 System to perform screening, surveillance and diagnostic colonoscopies, and Phase B will evaluate the safety and efficacy of the Triton 4.0 System to perform screening, surveillance and diagnostic colonoscopies.",[61,148,149,28],"2025-04-11",{"date":195,"type":33},"2025-04-20",{"date":197,"type":21},"2025-04-14",{"date":199,"type":21},"2025-07-31",{"name":158,"class":104},{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":207,"eligibilityCriteria":208,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":209,"targetDuration":211,"studyType":86,"phases":4,"briefSummary":212,"conditions":213,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":76},"100571510","study-on-the-feelings-of-euphoria-caused-by-remimazolam-during-gastroscopy-and-colonoscopy-and-their-related-factors-100571510","NCT06721195","Study on the Feelings of Euphoria Caused by Remimazolam During Gastroscopy and Colonoscopy and Their Related Factors","A Cross-Sectional Study on Euphoria Induced by Remimazolam During Gastrointestinal Endoscopy and Its Related Factors","ERGE","Inclusion Criteria:\n\n* Adults aged 18 to 65 years, regardless of gender.\n* Patients scheduled for routine painless gastrointestinal endoscopy, including gastroscopy, colonoscopy, or both.\n* ASA physical status classification: I or II.\n* BMI between 18 kg\u002Fm² and 28 kg\u002Fm².\n* Anticipated procedural duration of no more than 30 minutes.\n* Patients who have provided written informed consent after understanding the study purpose, procedures, and potential risks.\n\nExclusion Criteria:\n\n* History of psychiatric disorders such as schizophrenia, bipolar disorder, or personality disorders, or a history of alcohol, stimulant, or other substance abuse.\n* Known allergies or intolerance to any medication used in the study, including remimazolam, sufentanil, or benzodiazepines.\n* Patients requiring complex endoscopic procedures (e.g., ERCP, endoscopic submucosal dissection, endoscopic mucosal resection, or peroral endoscopic myotomy).\n* History of severe hepatic or renal disease.\n* Pregnant or lactating women.\n* Participation in another clinical study within the past three months.\n* Any condition or factor that, in the investigator's judgment, makes the patient unsuitable for participation in the study.",{"count":210,"type":21},305,"1 Day","This study aims to investigate the incidence of euphoria induced by remimazolam during gastrointestinal endoscopy and explore its related factors. Gastrointestinal endoscopy, a minimally invasive procedure, often causes discomfort and anxiety for patients. Remimazolam, a short-acting benzodiazepine, is increasingly used for sedation during these procedures due to its rapid onset, short metabolism, and controlled cardiorespiratory effects. This cross-sectional study will evaluate the effect of remimazolam on patient comfort, cooperation, and satisfaction during endoscopy, aiming to optimize sedation protocols and improve clinical outcomes.",[214,215,28],"Euphoria","Remimazolam Besylate","2024-12-03",{"date":218,"type":33},"2024-12-06",{"date":220,"type":33},"2024-08-01",{"date":222,"type":21},"2024-12-31",{"name":224,"class":40},"Zhangjie Yu",{"id":226,"slug":227,"hasResults":11,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":141,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":232,"targetDuration":4,"studyType":22,"phases":234,"briefSummary":235,"conditions":236,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":4},"100561762","observation-of-clinical-effect-of-new-oropharyngeal-airway-in-patients-with-oshas-during-painless-gastroenteroscopy-100561762","NCT06594380","Observation of Clinical Effect of New Oropharyngeal Airway in Patients With OSHAS During Painless Gastroenteroscopy","Observation of Clinical Effect of New Oropharyngeal Airway in Patients With Obstructive Sleep Apnea Hypoapnea Syndrome During Painless Gastroenteroscopy","Inclusion Criteria:\n\n* Age 18-65 years old\n* evidence of polysleep monitoring for diagnosis of OSAHS\n* written informed consent of patient or family member\n* painless stomach + colonoscopy\n* ASA grade I-II\n\nExclusion criteria:\n\n* Patients with clotting disorders or a tendency to oropharyngeal bleeding, mucosal damage or space occupation, difficulty in placing oropharyngeal airway, etc., who could not perform oropharyngeal airway ventilation;\n* Upper respiratory tract infections such as mouth, nose or throat;\n* Fever (core body temperature ≥37.5℃);\n* a confirmed diagnosis of pregnancy or breastfeeding;\n* Allergic to sedatives such as propofol or equipment such as tape;\n* Emergency surgery;\n* Multiple trauma;\n* SpO2 \\\u003C 95% before operation;\n* A history of drug and\u002For alcohol abuse within 2 years prior to the start of the screening period;(Drinking more than three times standard alcoholic beverages per day, equivalent to about 10g of alcohol or equivalent to 50g of Chinese liquor);\n* Patients with previous psychiatric and neurological diseases, such as depression, severe central nervous depression, Parkinson's disease, basal ganglia disease, schizophrenia, epilepsy, Alzheimer's disease, myasthenia gravis;\n* Currently participating in other clinical trials;\n* Patients who are deemed unfit by the investigator to participate in the trial;\n* Patients with a history of smoking should not participate in this study.",{"count":233,"type":21},130,[52],"the(obstructivesleepapneahypoapneasyndromeOSAHS) is a kind of to sleep appear periodically in the process of syndrome characterized by partial or complete obstruction of upper respiratory tract.Patients with obstruction during the attack, faced with percutaneous arterial blood oxygen saturation (percutaneousarterialoxygensaturation, SpO2) to reduce the risk of can also trigger hypercapnia and cardiovascular dysfunction.The global incidence of OSAS is 4.0% in males and 2.0% in females .Sedative drugs inhibit the response of OSAS patients to external stimuli and may cause pharyngeal muscle collapse, leading to an increased risk of respiratory adverse events during painless gastroscopy in this population .In fact, OSAS has been identified as an independent risk factor for endoscopic hypoxia .Currently, there is no special oropharyngeal ventilation device used during gastroenteroscopy. Recently, a new type of oropharyngeal ventilation channel has been developed and applied in clinic.Compared with the conventional nasal catheter, the new oropharyngeal airway nasal mask can better fit the patient's face, ensure the air tightness inside the nose mask and maximize the oxygen supply efficiency. The carbon dioxide outlet connected to the oropharyngeal airway body can not only collect the patient's exhaled gas, but also reduce the backflow of carbon dioxide gas.It can also access carbon dioxide detection equipment to monitor the patient's PCO2 at the end of breath in real time .In order to evaluate whether the new oropharyngeal airway can reduce the incidence of hypoxia during painless gastroenteroscopy in general patients, the study was designed to investigate the safety and efficacy of the new oropharyngeal airway.",[237,28,238],"OSAHS","Airway Complication of Anesthesia","2024-09-10",{"date":241,"type":33},"2024-09-19",{"date":243,"type":21},"2024-10-01",{"date":245,"type":21},"2025-12-01",{"name":247,"class":40},"Jianbo Wu",{"id":249,"slug":250,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":252,"acronym":4,"eligibilityCriteria":253,"healthyVolunteers":141,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":254,"targetDuration":4,"studyType":22,"phases":256,"briefSummary":257,"conditions":258,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":262,"completionDateStruct":263,"leadSponsor":264,"locationsCount":4},"100561496","application-of-new-oropharyngeal-airway-management-in-obese-patients-undergoing-painless-gastroenteroscopy-100561496","NCT06590922","Application of New Oropharyngeal Airway Management in Obese Patients Undergoing Painless Gastroenteroscopy","Inclusion Criteria:\n\n* Age 18-65 years\n* 30≤BMI≤40\n* Written informed consent of patient or family\n* painless stomach + colonoscopy\n* ASA grade I-II\n\nExclusion Criteria：\n\n* Patients with blood clotting disorders or a tendency to oropharyngeal bleeding, mucosal damage or space occupation, difficulty in placing oropharyngeal airway, etc., who cannot perform oropharyngeal airway ventilation;\n* Severe cardiac insufficiency (≤4mets);\n* Patients with severe renal insufficiency;\n* diagnosed severe hepatic insufficiency;\n* Diagnosed with chronic obstructive pulmonary disease (COPD) or currently suffering from other acute or chronic lung diseases, requiring long-term or intermittent oxygen therapy;\n* Increased intracranial pressure;\n* Upper respiratory tract infections such as mouth, nose or throat;\n* Fever (core body temperature ≥37.5℃);\n* A confirmed diagnosis of pregnancy or breastfeeding;\n* Allergic to sedatives such as propofol or equipment such as tape;\n* Emergency surgery;\n* Multiple trauma;\n* SpO2 \\\u003C 95% before operation;\n* A history of drug and\u002For alcohol abuse within 2 years prior to the start of the screening period;(Drinking more than three times standard alcoholic beverages per day, equivalent to about 10g of alcohol or equivalent to 50g of Chinese liquor);\n* Patients with previous psychiatric and neurological diseases, such as depression, severe central nervous depression, Parkinson's disease, basal ganglia disease, schizophrenia, epilepsy, Alzheimer's disease, myasthenia gravis;\n* Currently participating in other clinical trials;\n* Patients who are deemed unfit by the investigator to participate in the trial;\n* Patients with a history of smoking were excluded",{"count":255,"type":21},226,[52],"Painless endoscopy is a popular method of endoscopic diagnosis and treatment. Propofol combined with fentanyl general intravenous anesthesia has been widely used in painless endoscopic diagnosis and treatment.However, the combined application of the two has a significant respiratory center inhibition effect, resulting in a decrease in blood oxygen saturation of patients, especially obese patients, who are more likely to suffer from a sudden drop in blood oxygen and even threaten their lives .Due to the potential risk of upper airway obstruction in some obese patients, intraoperative hypopnea may occur during painless colonoscopy due to the influence of sedative and analgesic drugs, resulting in hypoxia in patients. In addition, the anatomical and pathological changes of obese patients themselves make hypoxia tolerance poor and airway establishment difficult, which may endanger the safety of patients .Currently, there is no special oropharyngeal ventilation device used during gastroenteroscopy. Recently, a new type of oropharyngeal ventilation channel has been developed and applied in clinic.Compared with the conventional nasal catheter, the new oropharyngeal airway nasal mask can better fit the patient's face, ensure the air tightness inside the nose mask and maximize the oxygen supply efficiency. The carbon dioxide outlet connected to the oropharyngeal airway body can not only collect the patient's exhaled gas, but also reduce the backflow of carbon dioxide gas.It can also access carbon dioxide detection equipment to monitor the patient's PCO2 at the end of breath in real time .In order to evaluate whether the new oropharyngeal airway can reduce the incidence of hypoxia in ordinary patients during painless gastroenteroscopy, the investigators prepared this study and explored the safety and effectiveness of the new oropharyngeal airway .",[27,28,259],"Airway Management","2024-09-08",{"date":241,"type":33},{"date":243,"type":21},{"date":245,"type":21},{"name":265,"class":40},"Qianfoshan Hospital"]