The Effect of Remimazolam Versus Propofol on Postoperative Extubation Time
31 août 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
82
Phase
- Phase 4
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Guangdong
-
Guangzhou, Guangdong, Chine, 510000
- The First Affiliated Hospital of Sun Yat-sen University
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: 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.
|
|
Expérimental: Rémizolam
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Extubation time (minutes)
Délai: 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.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Incidence of Adverse Events During Anesthesia Emergence (per patient)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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 (%)
Délai: 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)
Délai: 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.
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Xuyu Zhang, M.D., Department of Anesthesiology,The first affiliated hospital of Sun Yat-sen University
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
31 mai 2026
Achèvement primaire (Réel)
24 août 2026
Achèvement de l'étude (Réel)
31 août 2026
Dates d'inscription aux études
Première soumission
16 mai 2026
Première soumission répondant aux critères de contrôle qualité
21 mai 2026
Première publication (Réel)
28 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
1 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
31 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IRB[2025]680
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Description du régime IPD
All IPD that underlie results in a publication will be shared.
Délai de partage IPD
Starting 6 months after publication.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
- RSE
Informations sur les médicaments et les dispositifs, documents d'étude
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Étudie un produit d'appareil réglementé par la FDA américaine
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produit fabriqué et exporté des États-Unis.
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