Time to Loss of Consciousness With Remimazolam Versus Propofol During Anesthetic Induction for Laparoscopic Cholecystectomy: A Single-Center Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
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. The main question it aims to answer is: Does remimazolam change the time to loss of consciousness compared with propofol during anesthesia induction? Researchers 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. Participants will: * Be randomly assigned to receive either remimazolam or propofol for anesthesia induction. * Receive standard monitoring and anesthesia care throughout surgery. * Have their time to loss of consciousness, vital signs, and any adverse events recorded during the induction period.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 49
Healthy Volunteers: f
View:
• Patients aged 18 years or older.
• American Society of Anesthesiologists (ASA) physical status I or II.
• Scheduled to undergo elective laparoscopic cholecystectomy under Total Intravenous Anesthesia (TIVA).
Locations
Other Locations
Brazil
Hospital Univeritário da Universidade Federal de Sergipe
RECRUITING
Aracaju
Contact Information
Primary
Gabriel M Figueiredo Mascarenhas, MD
gabrielfigueiredomascarenhas@gmail.com
+5571987894554
Time Frame
Start Date:2026-08
Estimated Completion Date:2027-06
Participants
Target number of participants:66
Treatments
Experimental: Remimazolam
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/kg/h 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/kg/h, 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.
Active_comparator: Propofol
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/mL 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.