The Effect of Remimazolam Versus Propofol on Postoperative Extubation Time

NCT07611344 | Recruiting Phase 4

• 1 other identifier: IRB[2025]680
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Laparoscopic Hepatectomy

Keywords

Remimazolam; Propofol; Extubation time; Hepatectomy; Hemodynamics; PACU

Outcome Measures

Primary Outcomes (1)

• Extubation time (minutes)

  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.

Secondary Outcomes (8)

• Incidence of Adverse Events During Anesthesia Emergence (per patient)

  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)

  From the time of PACU admission until the time of PACU discharge, up to 24 hours postoperatively.

• Postoperative Hospital Stay (days)

  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)

  From the time of the end of surgery until the time of hospital discharge, up to 30 days postoperatively.

• Mean Arterial Pressure (mmHg)

  From the time of patient entering the operating room until the time of PACU admission, up to 24 hours postoperatively.

Study Arms (2)

Remimazolam

EXPERIMENTAL

Drug: Remimazolam

Propofol

ACTIVE COMPARATOR

Drug: propofol

Interventions

Remimazolam DRUG

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.

Remimazolam

propofol DRUG

Anesthesia induction: Intravenous injection of propofol 1.5-2.5 mg/kg. Anesthesia maintenance: Continuous infusion of propofol at 4-10 mg/kg/h.

Propofol

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ): Planned to undergo laparoscopic hepatectomy.
• ): Has signed the informed consent form.
• ): Aged 18 to 80 years.
• ): Body Mass Index (BMI) ranging from 18 to 28 kg/m².
• ): American Society of Anesthesiologists (ASA) physical status classification I to III.

You may not qualify if:

• ）: Severe cardiopulmonary dysfunction, or hepatic/renal dysfunction.
• ）: Diagnosis of neuropsychiatric disorders.
• ）: Pregnant or lactating women.
• ）: A history of allergy or contraindication to benzodiazepines, propofol, or any of their components.

Sponsors & Collaborators

• Xuyu Zhang: lead

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Interventions

remimazolam; Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Xuyu Zhang, M.D.

  Department of Anesthesiology,The first affiliated hospital of Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yueling Wang, resident

CONTACT

86-15734772576; wangyling25@mail2.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: May 16, 2026
• First Posted: May 28, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Starting 6 months after publication.

Locations

CN (1)