[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gastroscopy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gastroscopy":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"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":33,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100650684","phase-4-comparing-esketamine-and-remazolam-with-propofol-for-breathing-safety-in-pediatric-gastroscopy-100650684",false,"NCT07748884","Comparing Esketamine and Remazolam With Propofol for Breathing Safety in Pediatric Gastroscopy","A Comparative Study on the Incidence of Respiratory Adverse Events Between Esketamine Combined With Remazolam and Traditional Propofol in Pediatric Gastroscopy","Inclusion Criteria:\n\n1. Age 6 to 12 years, both sexes;\n2. American Society of Anesthesiologists (ASA) physical status I or II;\n3. Scheduled for elective gastroscopy or esophagogastroduodenoscopy (EGD) under anesthesia;\n4. Preoperative oxygen saturation of 100% while breathing room air;\n5. Weight within the normal range for age and gender according to the following reference values (inclusive of endpoints)\n\nExclusion Criteria:\n\n1. Contraindications to sedation or anesthesia, or a history of adverse events related to sedation\u002Fanesthesia；\n2. Known or suspected allergy to the study drug, benzodiazepines, or their reversal agents；\n3. History of respiratory disease within the past 2 weeks, or known difficult airway (modified Mallampati score III or IV)；\n4. History of cardiac, hepatic, renal dysfunction, or metabolic diseases；\n5. Patients with congenital diseases or other conditions that may interfere with the evaluation of efficacy outcomes.","ALL","6 Years","12 Years",{"count":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","Gastroscopy is important for diagnosing and treating upper gastrointestinal diseases in children. To ensure the procedure is safe and smooth, most children require sedation. Compared to adults, children have more fragile airways, lower lung capacity, and poorer oxygen reserves, making them more prone to breathing difficulties and low oxygen levels during sedation.\n\nEsketamine, a stronger form of ketamine, helps maintain heart rate and blood pressure and may reduce breathing-related risks. Remimazolam, a new short-acting sedative, acts quickly, allows faster recovery, and has a better safety profile than propofol-it doesn't cause breathing problems or injection pain.\n\nThe safety and effectiveness of combining remimazolam with esketamine for pediatric gastroscopy have not been well studied. This research will compare this new combination with the traditional propofol-based approach to evaluate its potential benefits and safety in children.",[27,28,29,30,31,32],"Adverse Respiratory Events","Hypoxemia","Children","Gastroscopy","Esketamine","Remimazolam",[34,28,29,35,31,32],"Adverse respiratory events","gastroscopy","NOT_YET_RECRUITING","2026-08-04",{"date":39,"type":40},"2026-08-06","ACTUAL",{"date":42,"type":21},"2026-08",{"date":44,"type":21},"2026-12",{"name":46,"class":47},"Second Affiliated Hospital of Wenzhou Medical University","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100582095","phase-3-a-clinical-trial-to-evaluate-the-efficacy-and-safety-of-methoxyethyl-etomidate-hydrochloride-for-sedationanesthesia-during-gastroscopycolonoscopy-100582095","NCT06858852","A Clinical Trial to Evaluate the Efficacy and Safety of Methoxyethyl Etomidate Hydrochloride for Sedation\u002FAnesthesia During Gastroscopy\u002FColonoscopy","A Multicenter, Randomized, Double-blind, Etomidate Parallel Controlled Phase III Clinical Trial Was Conducted to Evaluate the Efficacy and Safety of Methoxyethyl Etomidate Hydrochloride for Sedation\u002FAnesthesia During Gastroscopy\u002FColonoscopy","Inclusion Criteria:\n\n1. patients undergoing routine gastroscopy\u002Fcolonoscopy;\n2. age ≥ 18 and ≤ 75 years old, regardless of gender;\n3. American Society of Anesthesiologists (ASA) grade I-III;\n4. Body mass index (BMI) 18-30 kg\u002Fm2 (including the cut-off value) and body weight ≤100 kg;\n5. Serum cortisol concentrations were either normal or abnormal but not clinically significant as judged by the investigator\n6. Vital signs during screening:\n\n   respiratory rate ≥10 and ≤24 times\u002Fmin; Pulse oxygen saturation (SpO2) ≥95% while breathing air; Systolic blood pressure (SBP) ≥90mmHg and ≤160mmHg; Diastolic blood pressure (DBP) ≥60mmHg and ≤100mmHg; Heart rate (ECG) ≥55 and ≤100 beats\u002Fmin;\n7. Able to understand the procedures and methods of this study, willing to sign the informed consent and strictly abide by the trial protocol to complete the study.\n\nExclusion Criteria:\n\n1. patients with possible gastroduodenal outflow obstruction with retention of contents or upper gastrointestinal bleeding;\n2. patients who were known or suspected to have allergies or contraindications to the components of the investigational drug or the prescribed regimen, or who were suspected to have epilepsy or severe liver and kidney dysfunction;\n3. Predicted difficulty in intubation or ventilation (modified Markov score level III, level IV);\n4. having any of the following respiratory management risks before\u002Fat the time of screening: 1) history of asthma, wheezing; 2) sleep apnea syndrome;\n5. QTcF≥450 ms (male) or ≥470 ms (female) at screening and confirmed by review; Or clinically significant electrocardiographic abnormalities that were deemed by the investigator to be ineligible for the study;\n6. use of any of the following drugs or treatments before screening:1) enrolled in a clinical trial of any drug within 1 month before screening; 2) use of medications or treatments that affect cortical function within 3 days before screening; 3) Use of medications that may affect QT interval within 2 weeks before screening;\n7. During the screening period, the laboratory examination indicators exceeded the abnormal level and had clinical significance, and were not suitable for enrollment after evaluation by the investigators;\n8. pregnant and lactating women; The reluctance of women or men of childbearing potential to use contraception for the entire dosing period; Subjects (including male subjects) who plan to become pregnant within 3 months after the trial;\n9. Subjects with any other factors considered by the investigator to be ineligible for participation in the trial.","18 Years","75 Years",{"count":59,"type":21},270,[61],"PHASE3","A total of 270 subjects undergoing gastroscopy\u002Fcolonoscopy were randomly assigned to the methoxetomidate hydrochloride group and the etomidate group according to the ratio of 2:1 with etomidate as the control group.Neither the investigators nor the subjects were aware of the group assignments. Screening assessments for all subjects will be completed within D-14 to D-2 before the first dose. For all subjects who received the investigational drug, they were required to return to the research center on D2-5 to complete the corresponding examination before being discharged from the group. Compared with etomidate, the efficacy and safety of Methoxyethyl Etomidate Hydrochloride for sedation\u002Fanesthesia in gastroscopy\u002Fcolonoscopy were further evaluated.",[30,64],"Colonoscopy","2025-02-28",{"date":67,"type":40},"2025-03-05",{"date":69,"type":21},"2025-03",{"date":71,"type":21},"2025-12",{"name":73,"class":47},"Ahon Pharmaceutical Co., Ltd.",6]