Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

The Effect of Remimazolam Versus Propofol on Postoperative Extubation Time

21. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

82

Phase

  • Phase 4

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Rekrutierung
        • The First Affiliated Hospital of Sun Yat-sen University
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Sonstiges
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Propofol
Arzneimittel: 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.
Experimental: Remimazolam
Arzneimittel: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Extubation time (minutes)
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Incidence of Adverse Events During Anesthesia Emergence (per patient)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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 (%)
Zeitfenster: 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)
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Xuyu Zhang

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Dezember 2025

Primärer Abschluss (Geschätzt)

1. Dezember 2026

Studienabschluss (Geschätzt)

31. Dezember 2026

Studienanmeldedaten

Zuerst eingereicht

16. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

21. Mai 2026

Zuerst gepostet (Tatsächlich)

28. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

28. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

21. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • IRB[2025]680

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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

IPD-Sharing-Zeitrahmen

Starting 6 months after publication.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ICF
  • CSR

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur Remimazolam

Suchen Sie nach ähnlichen Studien

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

CROs by country

CROs in Lebanon

Bedingungen

Seltene Krankheiten

Drogeninterventionen

Nahrungsergänzungsmittel

Sponsor / Mitarbeiter

Standorte

Abonnieren