Time to Loss of Consciousness With Remimazolam Versus Propofol for Anesthetic Induction in Laparoscopic Cholecystectomy
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- What is being studied
- The protocol lists: Remimazolam, Propofol.
- Who it may be relevant to
- Registry conditions: Intravenous Anesthesia, Cholelithiasis. Basic parameters: 18 years — 49 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Time to Loss of Consciousness With Remimazolam Versus Propofol During Anesthetic Induction for Laparoscopic Cholecystectomy: A Single-Center Randomized Controlled Trial
Overview
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.
Detailed description
General anesthesia can be induced with several intravenous hypnotic agents. Propofol remains a standard choice due to its rapid onset and predictable clinical effect; however, it is frequently associated with dose-dependent cardiovascular depression. Remimazolam, an ultra-short-acting benzodiazepine, represents an alternative with a distinct metabolic pathway via tissue esterases, potentially offering greater hemodynamic stability. Nonetheless, current literature comparing induction kinetics between these two pharmacological strategies exhibits high heterogeneity, often driven by variations in drug delivery methods and mixed surgical profiles.
To improve the internal validity of these clinical comparisons, this protocol restricts the evaluation to a single, specific surgical model. Narrowing the clinical environment to a uniform surgical procedure eliminates major confounding variables-such as widely divergent operational durations, patient positioning dynamics, unexpected blood loss, and varying baseline nociceptive stimuli-which typically complicate broader, multi-procedural anesthesia trials.
Furthermore, because the physical characteristics of the study medications preclude complete investigator masking during drug administration, specific operational safeguards are built into the clinical workflow. Anesthesia delivery during the induction phase relies entirely on pre-specified, automated delivery algorithms (comparing a fixed-rate continuous infusion against a pharmacokinetic target-controlled model) rather than subjective, clinician-guided titration. Utilizing fixed algorithmic delivery protocols prevents clinical preferences from influencing drug administration, thereby controlling for potential execution bias.
Following the induction phase, physiological tracking and depth-of-anesthesia monitoring are managed through objective, automated indices to ensure that post-induction adjustments remain standardized across both evaluation groups. This structured approach ensures that the resulting clinical observations reflect the distinct pharmacological and pharmacokinetic profiles of the selected hypnotic strategies rather than confounding clinical management choices.
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 intraoperat - 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 infus
Primary outcome measures
- Time to Loss of Consciousness (TLOC) [Time frame: 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 outcome measures (7)
- Incidence of Anesthesia-Induced Hypotension [Time frame: From the exact initiation of anesthetic induction until the completion of the surgical procedure (estimated up to 2 hours).]
- Incidence of Perioperative Adverse Events [Time frame: From the initiation of anesthetic induction until 1 hour after arrival at the Post-Anesthesia Care Unit (PACU)]
- Incidence of Early Postoperative Delirium [Time frame: Within 1 hour after arrival at the Post-Anesthesia Care Unit (PACU).]
- Bispectral Index (BIS) Values at Key Anesthetic Milestones [Time frame: From initiation of anesthetic induction through the intraoperative period (estimated up to 2 hours).]
- Time to Tracheal Extubation [Time frame: From the cessation of anesthetic maintenance until tracheal extubation (estimated up to 20 minutes).]
- Incidence of Postoperative Pain Requiring Opioid Rescue [Time frame: Within 1 hour after arrival at the Post-Anesthesia Care Unit (PACU).]
- Incidence of Postoperative Nausea and Vomiting (PONV) [Time frame: Within 1 hour after arrival at the Post-Anesthesia Care Unit (PACU).]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Brazil · 1 center
- Hospital Univeritário da Universidade Federal de Sergipe — Aracaju
Identifiers
NCT: NCT07717684 · 97389426.1.0000.5546