Hospital Univeritário da Universidade Federal de Sergipe
Aracaju, Sergipe, Brazil
NCT Number: NCT07717684
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.
Trial opening soon.
Get Notified18 year–49 year
All sexes
Interventional
Phase 4
Aracaju, Sergipe, Brazil
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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).
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.
Time frame: From the exact initiation of anesthetic induction until the completion of the surgical procedure (estimated up to 2 hours).
Percentage of participants experiencing at least one episode of hypotension. Hypotension is operationally defined as a decrease in blood pressure of more than 20% from the participant's documented baseline value, or a mean arterial pressure (MAP) lower than 65 mmHg.
Time frame: From the initiation of anesthetic induction until 1 hour after arrival at the Post-Anesthesia Care Unit (PACU)
Proportion of participants experiencing specific anesthesia-related adverse events, including bradycardia (heart rate < 50bpm), episodes of apnea within the Post-Anesthesia Care Unit (PACU), or any clinical event requiring unplanned therapeutic interventions.
Time frame: Within 1 hour after arrival at the Post-Anesthesia Care Unit (PACU).
Percentage of participants with delirium at discharge from the Post-Anesthesia Care Unit (PACU), assessed using the 4AT (4 A's Test), a validated rapid screening tool for delirium.
Time frame: From initiation of anesthetic induction through the intraoperative period (estimated up to 2 hours).
Objective tracking of depth of anesthesia using bispectral index (BIS) values (measured on a scale from 0 to 100, where 100 indicates fully awake and 0 indicates flat-line EEG). Continuous values will be extracted and compared at specific clinical time points: at the initiation of induction, during laryngoscopy, and periodically throughout the intraoperative period.
Time frame: From the cessation of anesthetic maintenance until tracheal extubation (estimated up to 20 minutes).
The duration, measured in minutes, from the exact clinical cessation of the maintenance hypnotic delivery (propofol or remimazolam) and the remifentanil infusion until the safe and successful removal of the endotracheal tube.
Time frame: Within 1 hour after arrival at the Post-Anesthesia Care Unit (PACU).
Percentage of participants experiencing acute postoperative pain that necessitates the administration of supplemental opioid rescue analgesia as part of their recovery management.
Time frame: Within 1 hour after arrival at the Post-Anesthesia Care Unit (PACU).
Percentage of participants experiencing episodes of nausea, vomiting, or retching during the immediate recovery phase.
Contact information is provided by the study sponsor or research team.
Universidade Federal de Sergipe
Other
Time to Loss of Consciousness With Remimazolam Versus Propofol During Anesthetic Induction for Laparoscopic Cholecystectomy: A Single-Center Randomized Controlled Trial
Acronym: REMIPROP-LOC
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