Time to Loss of Consciousness With Remimazolam Versus Propofol for Anesthetic Induction in Laparoscopic Cholecystectomy | NCT07717684

NCT07717684

Overview

NCT ID: NCT07717684
Lead Sponsor: Universidade Federal de SergipeOTHER
Official Title: Time to Loss of Consciousness With Remimazolam Versus Propofol During Anesthetic Induction for Laparoscopic Cholecystectomy: A Single-Center Randomized Controlled Trial
Brief 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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 21, 2026Actual
Start Date: Aug 2026Estimated
Primary Completion Date: Jun 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

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).

Exclusion Criteria:

Patients younger than 18 years or older than 50 years

American Society of Anesthesiologists (ASA) physical status III to V

Body Mass Index (BMI) < 17.5 kg/m² or > 30 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

Study Plan

Study Type: Interventional
Phase: Phase 4
Enrollment: 66Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts and Locations

Central Contacts: Gabriel M Figueiredo Mascarenhas, MDContact
gabrielfigueiredomascarenhas@gmail.com

Similar Studies

Participant Group/Arms

RemimazolamExperimental

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.

Drug: Remimazolam

PropofolActive 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/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.

Drug: Propofol