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

NCT07717684 | Not Yet Recruiting Phase 4

• 1 other identifier: 97389426.1.0000.5546
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Intravenous Anesthesia; Cholelithiasis

Keywords

Propofol; Remimazolam; General Anesthesia; Intravenous Anesthesia

Outcome Measures

Primary Outcomes (1)

• Time to Loss of Consciousness (TLOC)

  The duration, measured in seconds, from the exact initiation of the intravenous hypnotic agent infusion (either remimazolam or propofol) until the participant achieves clinical loss of consciousness. Loss of consciousness is strictly defined as the co-occurrence of two clinical criteria: the complete loss of response to a standardized verbal command (calling the patient's name aloud) and the absence of the eyelash/palpebral reflex (córneo-palpebral reflex), assessed continuously during the anesthesia induction phase.

  From the initiation of the hypnotic agent infusion until the achievement of loss of consciousness (estimated time frame of up to 5 minutes during the anesthesia induction phase).

Secondary Outcomes (7)

• Incidence of Anesthesia-Induced Hypotension

  From the exact initiation of anesthetic induction until the completion of the surgical procedure (estimated up to 2 hours).

• Incidence of Perioperative Adverse Events

  From the initiation of anesthetic induction until 1 hour after arrival at the Post-Anesthesia Care Unit (PACU)

• Incidence of Early Postoperative Delirium

  Within 1 hour after arrival at the Post-Anesthesia Care Unit (PACU).

• Bispectral Index (BIS) Values at Key Anesthetic Milestones

  From initiation of anesthetic induction through the intraoperative period (estimated up to 2 hours).

• Time to Tracheal Extubation

  From the cessation of anesthetic maintenance until tracheal extubation (estimated up to 20 minutes).

Study Arms (2)

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/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

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/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

Interventions

Propofol DRUG

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/mL. 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.

Propofol

Remimazolam DRUG

Lyophilized powder reconstituted for intravenous injection. Administered via an electronic infusion pump at a fixed continuous induction rate of 6 mg/kg/h until clinical benchmarks are achieved. Maintenance is sustained at a baseline continuous infusion rate of 1 mg/kg/h. 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.

Remimazolam

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal de Sergipe: lead
• Cristália Produtos Químicos Farmacêuticos Ltda.: collaborator

Study Sites (1)

Hospital Univeritário da Universidade Federal de Sergipe

Aracaju, Sergipe, Brazil

Location

MeSH Terms

Conditions

Cholelithiasis

Interventions

remimazolam; Propofol

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Fabrício A Dias Antunes, MD, MSc, PhD

  Universidade Federal de Sergipe

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriel M Figueiredo Mascarenhas, MD

CONTACT

+5571987894554; gabrielfigueiredomascarenhas@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor at the Federal University of Sergipe (UFS)

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 21, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: IPD and supporting documents will be available beginning 12 months after publication of the primary results and will remain available for at least 5 years thereafter.
• Access Criteria: Access to de-identified IPD and supporting documents will be granted upon reasonable request to qualified researchers. Requests must include a methodologically sound proposal and a commitment to use the data only for research purposes aligned with ethical and scientific standards. Data will be shared through a controlled process after approval by the study team.

Locations

BR (1)