A Phase 4 interventional study of Remimazolam and Propofol in Intraoperative Hypotension and Hepatectomy, sponsored by Beijing Tsinghua Chang Gung Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Beijing Tsinghua Chang Gung Hospital · Phase 4, Interventional, and Prevention
The goal of this clinical trial is to learn whether remimazolam helps prevent low blood pressure better than propofol during major liver surgery in adults. All participants will have planned surgery to remove at least three liver segments.
The main question is whether participants who receive remimazolam have less low blood pressure while the surgeon removes liver tissue. Researchers will measure both how low the blood pressure falls and how long it stays low.
Researchers will randomly assign 224 participants to receive remimazolam or propofol to maintain general anesthesia. Participants will not know which drug they receive until their postoperative assessments are complete. The anesthesiologist giving the drug will know the assignment for safety reasons.
Participants will:
Researchers will also compare the use of medicines to support blood pressure, bleeding, blood transfusion, recovery after anesthesia, organ complications, heart injury, and adverse events.
Low central venous pressure management is commonly used during major hepatectomy to reduce bleeding from the hepatic veins. However, fluid restriction and the effects of general anesthetics may increase the risk, depth, or duration of intraoperative hypotension. Remimazolam may cause less hypotension than propofol, but evidence during major hepatectomy under low central venous pressure management remains limited.
This is an investigator-initiated, single-center, two-arm, parallel-group, randomized superiority trial. The study will enroll 224 adults scheduled for elective resection of at least three Couinaud liver segments. Participants will be assigned in a 1:1 ratio to receive remimazolam or propofol for maintenance of total intravenous anesthesia. Both groups will receive a common etomidate-based induction regimen, the same target depth of anesthesia, continuous invasive arterial pressure monitoring, and standardized protocols for low central venous pressure management and treatment of hypotension.
The primary observation period is the complete period of liver parenchymal transection during low central venous pressure management. The primary outcome integrates the depth and duration of mean arterial pressure below 65 mmHg during this period. Additional assessments will examine vasopressor use, blood loss, transfusion, recovery, organ complications, myocardial injury, and adverse events. Participants will be followed through postoperative day 30.
The attending anesthesiologist cannot be blinded because remimazolam and propofol differ in appearance, preparation, and administration. Participants will remain unaware of their assigned treatment until postoperative outcome assessment is complete. Postoperative assessors, arterial pressure data reviewers, clinical outcome adjudicators, and the primary statistician will remain blinded to treatment allocation.
885 studies on the registry are indexed under Hypotension; 195 are open to participants now.
This study's planned enrollment of 224 is above the median of 87 across 590 interventional studies indexed under Hypotension.
Browse Hypotension studies →Beijing Tsinghua Chang Gung Hospital is the lead sponsor of 108 studies on the registry; 56 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive a common intravenous induction regimen of etomidate 0.2 mg/kg, sufentanil 0.3 micrograms/kg, and cisatracurium 0.2 mg/kg. After tracheal intubation, remimazolam will be infused at 1.0 to 2.0 mg/kg/hour for maintenance of total intravenous anesthesia. The infusion will be titrated to a bispectral index of 40 to 60, clinical signs, and surgical stimulation and will be stopped when emergence is planned. Standardized low central venous pressure and hypotension-management protocols will be applied.
Drug: Remimazolam
Participants will receive a common intravenous induction regimen of etomidate 0.2 mg/kg, sufentanil 0.3 micrograms/kg, and cisatracurium 0.2 mg/kg. After tracheal intubation, propofol will be infused at 4.0 to 10.0 mg/kg/hour for maintenance of total intravenous anesthesia. The infusion will be titrated to a bispectral index of 40 to 60, clinical signs, and surgical stimulation and will be stopped when emergence is planned. Standardized low central venous pressure and hypotension-management protocols will be applied.
Drug: Propofol
After a common etomidate-based induction regimen and tracheal intubation, intravenous remimazolam will be infused at 1.0 to 2.0 mg/kg/hour for maintenance of general anesthesia. The dose will be titrated to a bispectral index of 40 to 60, clinical signs, and surgical stimulation. The infusion will be stopped when emergence is planned. Flumazenil will not be administered routinely.
After a common etomidate-based induction regimen and tracheal intubation, intravenous propofol will be infused at 4.0 to 10.0 mg/kg/hour for maintenance of general anesthesia. The dose will be titrated to a bispectral index of 40 to 60, clinical signs, and surgical stimulation. The infusion will be stopped when emergence is planned.
Time-weighted average of mean arterial pressure below 65 mmHg during liver parenchymal transection
The time-weighted average will quantify the depth and duration of hypotension during the complete period of liver parenchymal transection under low central venous pressure management. It will be calculated from quality-assessed invasive arterial pressure measurements. For periods when mean arterial pressure is below 65 mmHg, the difference between 65 mmHg and the observed pressure will be integrated over time. The resulting area will be divided by the duration of valid arterial pressure monitoring. The unit is mmHg. A value of 0 indicates that no valid mean arterial pressure measurement was below 65 mmHg. Higher values indicate a greater hypotension burden.
Time frame: From the start to the completion of liver parenchymal transection under low central venous pressure management, intraoperative
Cumulative norepinephrine-equivalent dose during liver parenchymal transection
The total dose of vasopressors administered during the complete liver parenchymal transection period under low central venous pressure management will be converted to norepinephrine equivalents using conversion rules prespecified before the first randomization. The cumulative dose will be normalized to body weight and reported in micrograms/kg.
Time frame: From the start to the completion of liver parenchymal transection under low central venous pressure management, intraoperative
Number of participants receiving any vasopressor during liver parenchymal transection
The number of participants who receive at least one vasopressor bolus or infusion during the complete liver parenchymal transection period under low central venous pressure management. Vasopressors include norepinephrine, ephedrine, and any other vasoactive drug administered to support arterial pressure.
Time frame: From the start to the completion of liver parenchymal transection under low central venous pressure management, intraoperative
Time-weighted average of mean arterial pressure below 65 mmHg during maintenance anesthesia
The time-weighted average will quantify the depth and duration of mean arterial pressure below 65 mmHg over the entire period of allocated maintenance anesthesia. For periods when mean arterial pressure is below 65 mmHg, the difference between 65 mmHg and the observed pressure will be integrated over time and divided by valid monitored time. The unit is mmHg. Higher values indicate a greater hypotension burden.
Time frame: From the start to the final discontinuation of the allocated maintenance anesthetic, intraoperative
Estimated intraoperative blood loss
The total volume of blood loss during surgery will be estimated from the surgical and anesthesia records and reported in milliliters.
Time frame: From surgical incision to completion of surgery, intraoperative
Number of participants receiving intraoperative red blood cell transfusion
The number of participants who receive any red blood cell transfusion during surgery.
Time frame: During surgery, intraoperative
Intraoperative red blood cell transfusion dose
The total dose of red blood cells administered to each participant during surgery will be recorded and reported in units.
Time frame: During surgery, intraoperative
Incidence of postoperative delirium (POD)
The number of participants who develop postoperative delirium (POD) within 7 postoperative days in each study group. Postoperative delirium will be assessed daily using the Confusion Assessment Method (CAM) or the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), as appropriate according to the participant's clinical status.
Time frame: From the end of surgery through postoperative Day 7
Number of participants with acute kidney injury within 7 postoperative days
The number of participants who develop acute kidney injury within 7 days after surgery according to Kidney Disease: Improving Global Outcomes criteria, based on postoperative serum creatinine and urine output information available in the clinical record.
Time frame: From the end of surgery through postoperative Day 7
Number of participants with grade B or C post-hepatectomy liver failure
The number of participants who develop grade B or C post-hepatectomy liver failure according to International Study Group of Liver Surgery criteria. Grade A post-hepatectomy liver failure will not be counted in this outcome.
Time frame: From postoperative day 5 through hospital discharge, assessed up to postoperative day 30
Number of participants with severe hypotension during maintenance anesthesia
The number of participants with at least one episode of mean arterial pressure below 55 mmHg lasting at least 1 minute during maintenance anesthesia.
Time frame: From the start to the final discontinuation of the allocated maintenance anesthetic, intraoperative
Number of participants with treated bradycardia during maintenance anesthesia
The number of participants who receive medication or another clinical intervention for bradycardia during maintenance anesthesia. Heart rate below 50 beats/minute will be used to identify bradycardic periods.
Time frame: From the start to the final discontinuation of the allocated maintenance anesthetic, intraoperative
Number of participants with myocardial injury after noncardiac surgery
The number of participants with myocardial injury after noncardiac surgery. The outcome requires high-sensitivity cardiac troponin I above the assay-specific 99th-percentile upper reference limit, evidence of an acute change from the preoperative value, and blinded adjudication that an ischemic mechanism is the most likely explanation. Only measurements obtained as part of routine clinical care will be used.
Time frame: From approximately 2 hours after surgery on postoperative Day 0 through postoperative Day 3
Peak postoperative high-sensitivity cardiac troponin I concentration
The highest high-sensitivity cardiac troponin I concentration recorded from postoperative Day 0 through postoperative Day 3 using measurements obtained as part of routine clinical care. Participation will not require an additional blood draw. Results will be reported using the clinical laboratory assay unit.
Time frame: From approximately 2 hours after surgery on postoperative Day 0 through postoperative Day 3
Number of participants with study drug-related adverse events
The number of participants with at least one adverse event considered related to the allocated maintenance anesthetic. Events will be assessed from first exposure through postoperative Day 7 or hospital discharge and again at the Day 30 follow-up. Unsolicited events reported between assessments will also be recorded.
Time frame: From first exposure to the allocated maintenance anesthetic through postoperative Day 30
Number of participants with study drug-related serious adverse events
The number of participants with at least one serious adverse event considered related to the allocated maintenance anesthetic. Serious adverse events include death, a life-threatening event, substantial prolongation of hospitalization, persistent or clinically important disability, or an intervention required to prevent such an outcome.
Time frame: From first exposure to the allocated maintenance anesthetic through postoperative Day 30
Number of participants with All-Cause mortality within 30 days after surgery
The number of participants who die from any cause within 30 days after surgery.
Time frame: From the end of surgery through postoperative Day 30
Plan to share: No — Individual participant data will not be shared with researchers outside the study team because the current ethics approval and informed consent form do not authorize external sharing of participant-level data. De-identified aggregate results will be reported in scientific publications and the trial registry, as applicable.
No publications or documents are linked to this record.
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Studies of the drug tested here: Remimazolam
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