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

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

Interventions

DRUG

Remimazolam

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.

DRUG

Propofol

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.

Sponsors & Collaborators

• Cristália Produtos Químicos Farmacêuticos Ltda.

  collaborator INDUSTRY

• Universidade Federal de Sergipe

  lead OTHER

Principal Investigators

• Fabrício A Dias Antunes, MD, MSc, PhD · Universidade Federal de Sergipe

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

49 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-31

Primary Completion

2027-06-30

Completion

2027-06-30

Countries

• Brazil

Study Locations