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

Официальное название

Time to Loss of Consciousness With Remimazolam Versus Propofol During Anesthetic Induction for Laparoscopic Cholecystectomy: A Single-Center Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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
• Препарат 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

Первичные конечные точки

• Time to Loss of Consciousness (TLOC) [Срок оценки: 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).]

Вторичные конечные точки (7)

• Incidence of Anesthesia-Induced Hypotension [Срок оценки: From the exact initiation of anesthetic induction until the completion of the surgical procedure (estimated up to 2 hours).]
• Incidence of Perioperative Adverse Events [Срок оценки: From the initiation of anesthetic induction until 1 hour after arrival at the Post-Anesthesia Care Unit (PACU)]
• Incidence of Early Postoperative Delirium [Срок оценки: Within 1 hour after arrival at the Post-Anesthesia Care Unit (PACU).]
• Bispectral Index (BIS) Values at Key Anesthetic Milestones [Срок оценки: From initiation of anesthetic induction through the intraoperative period (estimated up to 2 hours).]
• Time to Tracheal Extubation [Срок оценки: From the cessation of anesthetic maintenance until tracheal extubation (estimated up to 20 minutes).]
• Incidence of Postoperative Pain Requiring Opioid Rescue [Срок оценки: Within 1 hour after arrival at the Post-Anesthesia Care Unit (PACU).]
• Incidence of Postoperative Nausea and Vomiting (PONV) [Срок оценки: Within 1 hour after arrival at the Post-Anesthesia Care Unit (PACU).]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Бразилия · 1 центр

• Hospital Univeritário da Universidade Federal de Sergipe — Aracaju

Идентификаторы

NCT: NCT07717684 · 97389426.1.0000.5546

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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