Time to Lose Consciousness With Remimazolam vs Propofol for Anesthetic Induction
Official title: Time to Loss of Consciousness With Remimazolam Versus Propofol During Anesthetic Induction for Laparoscopic Cholecystectomy: A Single-Center Randomized Controlled Trial
Run by Universidade Federal de Sergipe · NCT07717684 · Data updated 2026-11-12
This study tests whether remimazolam changes the time to loss of consciousness compared with propofol for anesthesia induction in adults undergoing elective laparoscopic gallbladder removal.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 59 Years |
| Sex | All |
| Enrollment | 66 (estimated) |
| Sponsor | Universidade Federal de Sergipe Academic / other |
| Locations | 1 site (Aracaju, Sergipe) |
| Status | Recruiting |
| Started | August 21, 2026 |
| Main results expected | August 2027 |
| Study ends | August 2027 |
| Registry record updated | October 20, 2026 |
| Trial ID | NCT07717684 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–60 with ASA I–III status scheduled for elective laparoscopic cholecystectomy under TIVA.
✕Probably not a fit
Patients outside the age range, with ASA IV–V, BMI outside 17.5–35, or with significant organ dysfunction or neuromuscular issues may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 4 trial compares two intravenous drugs used to start general anesthesia in adults having elective laparoscopic cholecystectomy. Participants are randomly assigned to receive either remimazolam or propofol during induction, with standard monitoring and care throughout surgery. The trial records time to loss of consciousness, vital signs, and any adverse events during the induction period to assess hemodynamic stability and safety. By focusing on a single surgical procedure and controlled delivery, the study aims to reduce variability seen in prior comparisons. Automated delivery algorithms are used to manage drug administration to maintain consistency and safety.
Why it matters
Potential benefit: If remimazolam shows a favorable time to loss of consciousness and safety profile, it could offer a stable alternative for anesthesia induction in similar surgical settings.
How similar studies have gone: Previous comparisons of induction agents show heterogeneous results, making this focused, procedure-specific trial valuable and its success plausible if the methodology controls for confounding variables.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 18 years or older. * American Society of Anesthesiologists (ASA) physical status I, II or III. * Scheduled to undergo elective laparoscopic cholecystectomy under Total Intravenous Anesthesia (TIVA). Exclusion Criteria: * Patients younger than 18 years or older than 60 years * American Society of Anesthesiologists (ASA) physical status IV to V * Body Mass Index (BMI) \< 17.5 kg/m² or \> 35 kg/m² * Hemodynamically unstable patients * Altered or impaired renal or hepatic function * Neuromuscular disorders * History of alcohol or drug dependence * History of allergy or hypersensitivity to any of the anesthetic medications utilized in the protocol
Where it's running
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Hospital Univeritário da Universidade Federal de Sergipe
Aracaju, Sergipe, Brazil Recruiting
Study contacts
- Principal investigator: Fabrício A Dias Antunes, MD, MSc, PhD — Universidade Federal de Sergipe
- Study coordinator: Gabriel M Figueiredo Mascarenhas, MD
- Email: gabrielfigueiredomascarenhas@gmail.com
- Phone: +5571987894554
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.