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NCT Number: NCT07611344

The Effect of Remimazolam Versus Propofol on Postoperative Extubation Time

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.

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Key information

Conditions

Laparoscopic Hepatectomy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location status: Recruiting

Location contact

Yueling Wang, resident

CONTACT

[email protected]

86-15734772576

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Extubation time (minutes)

    Time frame: 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.

Secondary outcomes

  1. Incidence of Adverse Events During Anesthesia Emergence (per patient)

    Time frame: 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.

  2. PACU Length of Stay (minutes)

    Time frame: 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.

  3. Postoperative Hospital Stay (days)

    Time frame: 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.

  4. Incidence of Postoperative Complications (per patient)

    Time frame: 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.

  5. Mean Arterial Pressure (mmHg)

    Time frame: 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).

  6. Heart Rate (bpm)

    Time frame: 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).

  7. Stroke Volume Variation (%)

    Time frame: 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).

  8. Cardiac Index (L/min/m²)

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Yueling Wang, resident

CONTACT

[email protected]

86-15734772576

Sponsors and collaborators

Lead sponsor

Xuyu Zhang

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 28, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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