Laparoscopic HepatectomyPhase 4NCT07611344
The Effect of Remimazolam Versus Propofol on Postoperative Extubation Time
A Phase 4 study testing Remimazolam and propofol in people with Laparoscopic Hepatectomy, run by Xuyu Zhang at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Laparoscopic Hepatectomy
- What is being tested?
- Remimazolam and propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteChina
- Study dates
- 31 May 2026to 31 Aug 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510000
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Laparoscopic Hepatectomy
- Being tested
- Remimazolam, propofol
- Keywords
- Remimazolam, Propofol, Extubation time, Hepatectomy, Hemodynamics, PACU
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
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.
propofolDrug
Anesthesia induction: Intravenous injection of propofol 1.5-2.5 mg/kg. Anesthesia maintenance: Continuous infusion of propofol at 4-10 mg/kg/h.
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam | Experimental | Not described Receives: Drug: Remimazolam |
| Propofol | Active comparator | Not described Receives: Drug: propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extubation time (minutes)
The time (in minutes) from stopping intravenous sedative infusion to tracheal extubation.
Measured: 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)
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.
Measured: 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)
The time (in minutes) from PACU admission to PACU discharge.
Measured: From the time of PACU admission until the time of PACU discharge, up to 24 hours postoperatively.
Postoperative Hospital Stay (days)
The time (in days) from the end of surgery to hospital discharge.
Measured: 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)
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.
Measured: From the time of the end of surgery until the time of hospital discharge, up to 30 days postoperatively.
Mean Arterial Pressure (mmHg)
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).
Measured: From the time of patient entering the operating room until the time of PACU admission, up to 24 hours postoperatively.
Heart Rate (bpm)
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).
Measured: From the time of patient entering the operating room until the time of PACU admission, up to 24 hours postoperatively.
Stroke Volume Variation (%)
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).
Measured: 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)
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).
Measured: From the time of patient entering the operating room until the time of PACU admission, up to 24 hours postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start31 May 2026
- Primary completion24 Aug 2026
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic HepatectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xuyu Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xuyu Zhang, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Xuyu Zhang, M.D., Principal investigator, Department of Anesthesiology,The first affiliated hospital of Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07611344
- Sponsor's protocol ID
- IRB[2025]680
- Status last verified
- Aug 2026
- First submitted
- 16 May 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Remimazolam Versus Propofol on Postoperative Extubation Time in Patients Undergoing Laparoscopic Hepatectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07611344
- Acronym / sponsor ID
- IRB[2025]680
- Conditions
- Laparoscopic Hepatectomy
- Keywords
- Remimazolam, Propofol, Extubation time, Hepatectomy, Hemodynamics, PACU
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Xuyu ZhangUniversity, hospital or other
- Study start
- 31 May 2026 (actual)
- Primary completion
- 24 Aug 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 28 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remimazolam | Experimental | Drug: Remimazolam |
| Propofol | Active comparator | Drug: propofol |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RemimazolamAnesthesia induction: Intravenous injection of remimazolam 0.2-0.4 mg/kg. Anesthesia maintenance: Continuous infusion of remimazolam at 0.4-0.7mg/kg/h. | Drug | Remimazolam |
| propofolAnesthesia induction: Intravenous injection of propofol 1.5-2.5 mg/kg. Anesthesia maintenance: Continuous infusion of propofol at 4-10 mg/kg/h. | Drug | Propofol |
Primary outcome
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.
8 secondary outcomes
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.
PACU Length of Stay (minutes)
Time frame: From the time of PACU admission until the time of PACU discharge, up to 24 hours postoperatively.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xuyu Zhang, M.D. principal investigator
Department of Anesthesiology,The first affiliated hospital of Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Remimazolam and propofol in people with Laparoscopic Hepatectomy, run by Xuyu Zhang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.