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The Effect of Remimazolam Versus Propofol on Postoperative Extubation Time

21. maj 2026 opdateret af: Xuyu Zhang

The Effect of Remimazolam Versus Propofol on Postoperative Extubation Time in Patients Undergoing Laparoscopic Hepatectomy: A Randomized Controlled Trial

This clinical trial aims to help us understand how two drugs, Propofol and Remazoloam, affect when researchers remove a Participants' breathing tube after liver surgery (laparoscopic liver resection).The main research questions include: comparing the time to breathing tube removal between patients who receive each drug, comparing changes in heart rate and blood pressure during surgery, and comparing the rates of unwanted medical events after surgery. Researchers will give either Propofol or Remimazolam as a sedative medicine for anesthesia. This will allow the researchers to compare the time to breathing tube removal after surgery. Participants will complete their surgery according to a pre-planned surgical plan.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study is a clinical randomized controlled trial aimed at comparing the postoperative extubation time of remimazolam versus propofol in patients undergoing laparoscopic liver resection. Additionally, the study will compare intraoperative hemodynamic parameters, the incidence of adverse events during the anesthesia emergence period, length of stay in the post-anesthesia care unit (PACU), hospital length of stay, and the incidence of postoperative complications. Patients meeting the inclusion criteria will sign informed consent forms and be randomly assigned to one of two groups. Routine preoperative preparation will be performed. After entering the operating room, anesthesia induction and maintenance will be carried out according to the study protocol. After surgery, all patients will be transferred to the PACU. Extubation will be performed when extubation criteria are met, and patients will be returned to the ward when the Steward recovery score reaches ≥4. Data on postoperative extubation time, PACU stay, hospital length of stay, and postoperative complications will be recorded. Finally, data analysis and results reporting will be conducted.This trial can provide meaningful references for clinical drug selection. At the same time, this study will fill the gaps in clinical evidence in this field.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

82

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510000
        • Rekruttering
        • The First Affiliated Hospital of Sun Yat-Sen University
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • 1): Planned to undergo laparoscopic hepatectomy.

    2): Has signed the informed consent form.

    3): Aged 18 to 80 years.

    4): Body Mass Index (BMI) ranging from 18 to 28 kg/m².

    5): American Society of Anesthesiologists (ASA) physical status classification I to III.

Exclusion Criteria:

  • 1）: Severe cardiopulmonary dysfunction, or hepatic/renal dysfunction.

    2）: Diagnosis of neuropsychiatric disorders.

    3）: Pregnant or lactating women.

    4）: A history of allergy or contraindication to benzodiazepines, propofol, or any of their components.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Propofol
Medicin: propofol
Anesthesia induction: Intravenous injection of propofol 1.5-2.5 mg/kg. Anesthesia maintenance: Continuous infusion of propofol at 4-10 mg/kg/h.
Eksperimentel: Remimazolam
Medicin: Remimazolam
Anesthesia induction: Intravenous injection of remimazolam 0.2-0.4 mg/kg. Anesthesia maintenance: Continuous infusion of remimazolam at 0.4-0.7mg/kg/h.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Extubation time (minutes)
Tidsramme: From the time of cessation of intravenous sedative infusion until the time of tracheal extubation, up to 24 hours postoperatively.
The time (in minutes) from stopping intravenous sedative infusion to tracheal extubation.
From the time of cessation of intravenous sedative infusion until the time of tracheal extubation, up to 24 hours postoperatively.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of Adverse Events During Anesthesia Emergence (per patient)
Tidsramme: From the time of cessation of continuous intravenous sedative infusion until the time of PACU discharge, up to 24 hours postoperatively.
Incidence (per patient) of adverse events including nausea and vomiting, hypotension (MAP < 60 mmHg or MAP < 80% of baseline value), hypoxemia (SpO₂ < 90%), emergence agitation, dizziness, sore throat, hoarseness, shivering, occurring from cessation of continuous intravenous sedative infusion until PACU discharge.
From the time of cessation of continuous intravenous sedative infusion until the time of PACU discharge, up to 24 hours postoperatively.
PACU Length of Stay (minutes)
Tidsramme: From the time of PACU admission until the time of PACU discharge, up to 24 hours postoperatively.
The time (in minutes) from PACU admission to PACU discharge.
From the time of PACU admission until the time of PACU discharge, up to 24 hours postoperatively.
Postoperative Hospital Stay (days)
Tidsramme: From the time of the end of surgery until the time of hospital discharge, up to 30 days postoperatively.
The time (in days) from the end of surgery to hospital discharge.
From the time of the end of surgery until the time of hospital discharge, up to 30 days postoperatively.
Incidence of Postoperative Complications (per patient)
Tidsramme: From the time of the end of surgery until the time of hospital discharge, up to 30 days postoperatively.
Incidence (per patient) of postoperative complications including pleural effusion, ascites (or peritoneal effusion), atelectasis, pulmonary embolism, kidney injury, wound infection, etc., occurring from the end of surgery to hospital discharge.
From the time of the end of surgery until the time of hospital discharge, up to 30 days postoperatively.
Mean Arterial Pressure (mmHg)
Tidsramme: From the time of patient entering the operating room until the time of PACU admission, up to 24 hours postoperatively.
Mean arterial pressure (MAP) measured at time points: before anesthesia induction (T0), after anesthesia induction but before tracheal intubation (T1), immediately after tracheal intubation (T2), at skin incision (T3), at the start of porta hepatis clamping (T4), 5 minutes after porta hepatis clamping (T5), 10 minutes after porta hepatis clamping (T6), at the end of porta hepatis clamping (T7), 1 minute after porta hepatis release (T8), 3 minutes after porta hepatis release (T9), at the end of surgery (T10), and upon PACU admission (T11).
From the time of patient entering the operating room until the time of PACU admission, up to 24 hours postoperatively.
Heart Rate (bpm)
Tidsramme: From the time of patient entering the operating room until the time of PACU admission, up to 24 hours postoperatively.
Heart rate (HR) measured at time points: before anesthesia induction (T0), after anesthesia induction but before tracheal intubation (T1), immediately after tracheal intubation (T2), at skin incision (T3), at the start of porta hepatis clamping (T4), 5 minutes after porta hepatis clamping (T5), 10 minutes after porta hepatis clamping (T6), at the end of porta hepatis clamping (T7), 1 minute after porta hepatis release (T8), 3 minutes after porta hepatis release (T9), at the end of surgery (T10), and upon PACU admission (T11).
From the time of patient entering the operating room until the time of PACU admission, up to 24 hours postoperatively.
Stroke Volume Variation (%)
Tidsramme: From the time of patient entering the operating room until the time of PACU admission, up to 24 hours postoperatively.
Stroke volume variation (SVV) measured at time points: before anesthesia induction (T0), after anesthesia induction but before tracheal intubation (T1), immediately after tracheal intubation (T2), at skin incision (T3), at the start of porta hepatis clamping (T4), 5 minutes after porta hepatis clamping (T5), 10 minutes after porta hepatis clamping (T6), at the end of porta hepatis clamping (T7), 1 minute after porta hepatis release (T8), 3 minutes after porta hepatis release (T9), at the end of surgery (T10), and upon PACU admission (T11).
From the time of patient entering the operating room until the time of PACU admission, up to 24 hours postoperatively.
Cardiac Index (L/min/m²)
Tidsramme: From the time of patient entering the operating room until the time of PACU admission, up to 24 hours postoperatively.
Cardiac index (CI) measured at time points: before anesthesia induction (T0), after anesthesia induction but before tracheal intubation (T1), immediately after tracheal intubation (T2), at skin incision (T3), at the start of porta hepatis clamping (T4), 5 minutes after porta hepatis clamping (T5), 10 minutes after porta hepatis clamping (T6), at the end of porta hepatis clamping (T7), 1 minute after porta hepatis release (T8), 3 minutes after porta hepatis release (T9), at the end of surgery (T10), and upon PACU admission (T11).
From the time of patient entering the operating room until the time of PACU admission, up to 24 hours postoperatively.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Xuyu Zhang

Efterforskere

  • Ledende efterforsker: Xuyu Zhang, M.D., Department of Anesthesiology,The first affiliated hospital of Sun Yat-sen University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. december 2025

Primær færdiggørelse (Anslået)

1. december 2026

Studieafslutning (Anslået)

31. december 2026

Datoer for studieregistrering

Først indsendt

16. maj 2026

Først indsendt, der opfyldte QC-kriterier

21. maj 2026

Først opslået (Faktiske)

28. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IRB[2025]680

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

All IPD that underlie results in a publication will be shared.

IPD-delingstidsramme

Starting 6 months after publication.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

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