Time to Loss of Consciousness With Remimazolam Versus Propofol During Anesthetic Induction for Laparoscopic Cholecystectomy: A Single-Center Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Time to Loss of Consciousness (TLOC)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
研究组 & 干预措施
Propofol
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.
干预措施: Propofol (Drug)
Remimazolam
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.
干预措施: Remimazolam (Drug)
结局指标
主要结局
Time to Loss of Consciousness (TLOC)
时间窗: 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).
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.
次要结局
- 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).)
- Incidence of Postoperative Pain Requiring Opioid Rescue(Within 1 hour after arrival at the Post-Anesthesia Care Unit (PACU).)
- Incidence of Postoperative Nausea and Vomiting (PONV)(Within 1 hour after arrival at the Post-Anesthesia Care Unit (PACU).)
- Incidence of Anesthesia-Induced Hypotension(From the exact initiation of anesthetic induction until the completion of the surgical procedure (estimated up to 2 hours).)
研究者
Fabrício Dias Antunes
Adjunct Professor at the Federal University of Sergipe (UFS)
Universidade Federal de Sergipe