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Time to Loss of Consciousness With Remimazolam Versus Propofol for Anesthetic Induction in Laparoscopic Cholecystectomy (REMIPROP-LOC)

15. července 2026 aktualizováno: Fabrício Dias Antunes, Universidade Federal de Sergipe

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

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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

66

Fáze

  • Fáze 4

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Brazílie
    • Sergipe
      • Aracaju, Sergipe, Brazílie
        • Hospital Univeritário da Universidade Federal de Sergipe
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Lék: 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.
Aktivní komparátor: 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.
Lék: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Time to Loss of Consciousness (TLOC)
Časové okno: 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.
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).

Sekundární výstupní opatření

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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Universidade Federal de Sergipe

Spolupracovníci

Cristália Produtos Químicos Farmacêuticos Ltda.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Fabrício A Dias Antunes, MD, MSc, PhD, Universidade Federal de Sergipe

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. srpna 2026

Primární dokončení (Odhadovaný)

1. června 2027

Dokončení studie (Odhadovaný)

1. června 2027

Termíny zápisu do studia

První předloženo

8. července 2026

První předloženo, které splnilo kritéria kontroly kvality

15. července 2026

První zveřejněno (Aktuální)

21. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

21. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

15. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 97389426.1.0000.5546

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Popis plánu IPD

Individual participant data (IPD) underlying the published results will be shared upon reasonable request after publication of the main findings. All shared data will be fully de-identified to protect participant privacy. Access will be granted to qualified researchers whose proposed use is methodologically sound and ethically appropriate. Data will be provided through a controlled process and only for research purposes aligned with the objectives of the study.

Časový rámec sdílení IPD

IPD and supporting documents will be available beginning 12 months after publication of the primary results and will remain available for at least 5 years thereafter.

Kritéria přístupu pro sdílení IPD

Access to de-identified IPD and supporting documents will be granted upon reasonable request to qualified researchers. Requests must include a methodologically sound proposal and a commitment to use the data only for research purposes aligned with ethical and scientific standards. Data will be shared through a controlled process after approval by the study team.

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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