[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648126":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":39,"responsibleParty":58,"collaborators":61,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":25,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Universidade Federal de Sergipe","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Remimazolam","EXPERIMENTAL","Patients will receive intravenous remimazolam for both the induction and maintenance of general anesthesia. Anesthesia induction will be initiated via continuous intravenous infusion at a fixed rate of 6 mg\u002Fkg\u002Fh until loss of consciousness is achieved. Following induction, anesthesia maintenance will be transitioned to a continuous intravenous infusion of remimazolam at a baseline rate of 1 mg\u002Fkg\u002Fh, which will be titrated dynamically to maintain objective depth-of-anesthesia monitoring using a bispectral index (BIS) target value between 40 and 60 until the end of the surgical procedure.",[13],"Drug: Remimazolam",{"label":15,"type":16,"description":17,"interventionNames":18},"Propofol","ACTIVE_COMPARATOR","Patients will receive intravenous propofol for both the induction and maintenance of general anesthesia. Anesthesia induction will be performed using a target-controlled infusion (TCI) model with a fixed target concentration of 4 mcg\u002FmL until loss of consciousness is achieved. Following induction, anesthesia maintenance will be continued via propofol infusion, titrated dynamically to maintain objective depth-of-anesthesia monitoring using a bispectral index (BIS) target value between 40 and 60 until the end of the surgical procedure.",[19],"Drug: Propofol",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Lyophilized powder reconstituted for intravenous injection. Administered via an electronic infusion pump at a fixed continuous induction rate of 6 mg\u002Fkg\u002Fh until clinical benchmarks are achieved. Maintenance is sustained at a baseline continuous infusion rate of 1 mg\u002Fkg\u002Fh. To ensure a strictly standardized anesthetic baseline, all patients receive a uniform, weight-based co-administration of intravenous fentanyl and a neuromuscular blocking agent at induction, followed by a continuous intraoperative analgesic infusion of remifentanil via target-controlled infusion (TCI) guided by the Minto model (effect-site targeting). Maintenance remimazolam doses are precisely titrated based on real-time bispectral index (BIS) values to target a depth of anesthesia between 40 and 60.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Intravenous 1% lipid emulsion formulation of propofol. Administered via an automated target-controlled infusion (TCI) system programmed with the Marsh pharmacokinetic model. Induction is initiated at a fixed effect-site target concentration of 4 mcg\u002FmL. To ensure a strictly standardized anesthetic baseline, all patients receive a uniform, weight-based co-administration of intravenous fentanyl and a neuromuscular blocking agent at induction, followed by a continuous intraoperative analgesic infusion of remifentanil via target-controlled infusion (TCI) guided by the Minto model (effect-site targeting). Maintenance propofol infusion rates are dynamically adjusted to maintain an objective bispectral index (BIS) within the 40-60 range.",[15],[30],{"name":31,"affiliation":5,"role":32},"Fabrício A Dias Antunes, MD, MSc, PhD","PRINCIPAL_INVESTIGATOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":25,"email":38},"Gabriel M Figueiredo Mascarenhas, MD","CONTACT","+5571987894554","gabrielfigueiredomascarenhas@gmail.com",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Hospital Univeritário da Universidade Federal de Sergipe","RECRUITING","Aracaju","Sergipe","Brazil","BR",{"type":48,"coordinates":49},"Point",[50,51],-37.07167,-10.91111,{"lat":51,"lon":50},[54],{"name":55,"role":36,"phone":56,"phoneExt":25,"email":57},"Grace D Anne Azevedo Doria, BPharm, MSc, PhD","+55 (79) 2105-1782","setgpi.huse@hubrasil.gov.br",{"type":32,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Fabrício Dias Antunes","Adjunct Professor at the Federal University of Sergipe (UFS)",[62],{"name":63,"class":64},"Cristália Produtos Químicos Farmacêuticos Ltda.","INDUSTRY","100648126","phase-4-time-to-loss-of-consciousness-with-remimazolam-versus-propofol-for-anesthetic-induction-in-laparoscopic-cholecystectomy-100648126",false,"NCT07717684","Time to Loss of Consciousness With Remimazolam Versus Propofol for Anesthetic Induction in Laparoscopic Cholecystectomy","Time to Loss of Consciousness With Remimazolam Versus Propofol During Anesthetic Induction for Laparoscopic Cholecystectomy: A Single-Center Randomized Controlled Trial","REMIPROP-LOC","Inclusion Criteria:\n\n* Patients aged 18 years or older.\n* American Society of Anesthesiologists (ASA) physical status I or II.\n* Scheduled to undergo elective laparoscopic cholecystectomy under Total Intravenous Anesthesia (TIVA).\n\nExclusion Criteria:\n\n* Patients younger than 18 years or older than 50 years\n* American Society of Anesthesiologists (ASA) physical status III to V\n* Body Mass Index (BMI) \\\u003C 17.5 kg\u002Fm² or \\> 30 kg\u002Fm²\n* Hemodynamically unstable patients\n* Altered or impaired renal or hepatic function\n* Neuromuscular disorders\n* History of alcohol or drug dependence\n* History of allergy or hypersensitivity to any of the anesthetic medications utilized in the protocol","ALL","18 Years","49 Years",{"count":77,"type":78},66,"ESTIMATED","INTERVENTIONAL",[81],"PHASE4","The goal of this clinical trial is to compare two medicines used to induce general anesthesia in adults undergoing elective laparoscopic cholecystectomy. The study aims to determine whether remimazolam leads to a different time to loss of consciousness than propofol.\n\nThe main question it aims to answer is: Does remimazolam change the time to loss of consciousness compared with propofol during anesthesia induction?\n\nResearchers will compare remimazolam with propofol to evaluate the time required for participants to lose consciousness. The study will also compare blood pressure, heart rate, and other safety outcomes during anesthesia induction.\n\nParticipants will:\n\n* Be randomly assigned to receive either remimazolam or propofol for anesthesia induction.\n* Receive standard monitoring and anesthesia care throughout surgery.\n* Have their time to loss of consciousness, vital signs, and any adverse events recorded during the induction period.",[84,85],"Intravenous Anesthesia","Cholelithiasis",[15,9,87,84],"General Anesthesia","2026-08-02",{"date":90,"type":91},"2026-08-04","ACTUAL",{"date":93,"type":78},"2026-08",{"date":95,"type":78},"2027-06",{"name":5,"class":6},1]