Intraoperative HypotensionPhase 4NCT07789275
Remimazolam Versus Propofol for Maintenance of Anaesthesia During Major Hepatectomy Under Low Central Venous Pressure
A Phase 4 study testing Remimazolam and Propofol in people with Intraoperative Hypotension and Hepatectomy, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Intraoperative Hypotension, 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
- 224 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to Aug 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 85 years
- Scheduled for elective liver resection
- Preoperative surgical plan includes resection of at least three Couinaud liver segments
- Planned use of low central venous pressure management, general anesthesia, invasive arterial pressure monitoring, and central venous pressure monitoring
- American Society of Anesthesiologists physical status II or III
- Both study anesthesia strategies are considered clinically appropriate
- Able to understand the study information and provide written informed consent
Who cannot join
- Emergency surgery or inability to complete written informed consent before surgery
- Known contraindication or serious hypersensitivity to remimazolam, another benzodiazepine, propofol, or a relevant excipient
- Preoperative shock, ongoing vasoactive drug support, or another hemodynamically unstable condition that makes either study anesthesia strategy unsafe
- Child-Pugh class C, Model for End-Stage Liver Disease score of 20 or higher, or end-stage liver disease in the investigator's judgment
- Massive ascites, recent variceal bleeding, clinically important hypersplenism with severe thrombocytopenia, or portal hypertension sufficient to substantially alter circulatory management
- Regular long-term benzodiazepine use, drug dependence, or alcohol misuse expected to affect the pharmacological evaluation
Show all 10Show fewer
- Clinical requirement for an inhalational anesthetic or another maintenance anesthesia strategy incompatible with randomized assignment
- Pregnant or breastfeeding
- Concurrent participation in another interventional study that may affect the primary outcome
- Any other condition that, in the investigator's judgment, makes participation unsafe or prevents completion of the study procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218
Zhifeng Gao, MD, +86-15801249466, gzfa02461@btch.edu.cn
About this study
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.
Read more
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:
- Receive one of the two study drugs during surgery
- Have their blood pressure monitored continuously
- Receive standard treatment if their blood pressure becomes low
- Complete follow-up through 30 days after surgery
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.
Read the detailed description
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.
- Conditions
- Intraoperative Hypotension, Hepatectomy
- Being tested
- Remimazolam, Propofol
- Keywords
- Remimazolam, Propofol, Major Hepatectomy, Low Central Venous Pressure, Total Intravenous Anesthesia, Mean Arterial Pressure, Time-Weighted Average, Perioperative Hemodynamics, Liver Parenchymal Transection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
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.
PropofolDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam Maintenance Anesthesia | Experimental | 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. Receives: Drug: Remimazolam |
| Propofol Maintenance Anesthesia | Active comparator | 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. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the start to the completion of liver parenchymal transection under low central venous pressure management, intraoperative
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From the end of surgery through postoperative Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start1 Sep 2026
- Primary completionJul 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative HypotensionStudies of the same condition, open and under way.
- More trials run by Beijing Tsinghua Chang Gung HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhifeng Gao, Beijing Tsinghua Chang Gung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07789275
- Sponsor's protocol ID
- 27034-0-01
- Status last verified
- Nov 2026
- First submitted
- 21 Aug 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remimazolam Versus Propofol for Maintenance of Anaesthesia During Major Hepatectomy Under Low Central Venous Pressure
- ClinicalTrials.gov ID
- NCT07789275
- Acronym / sponsor ID
- 27034-0-01
- Conditions
- Intraoperative Hypotension, Hepatectomy
- Keywords
- Remimazolam, Propofol, Major Hepatectomy, Low Central Venous Pressure, Total Intravenous Anesthesia, Mean Arterial Pressure, Time-Weighted Average, Perioperative Hemodynamics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 27 Aug 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.
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:
- Receive one of the two study drugs during surgery
- Have their blood pressure monitored continuously
- Receive standard treatment if their blood pressure becomes low
- Complete follow-up through 30 days after surgery
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remimazolam Maintenance Anesthesia | Experimental | Drug: RemimazolamParticipants 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. |
| Propofol Maintenance Anesthesia | Active comparator | Drug: PropofolParticipants 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 to 85 years
- Scheduled for elective liver resection
- Preoperative surgical plan includes resection of at least three Couinaud liver segments
- Planned use of low central venous pressure management, general anesthesia, invasive arterial pressure monitoring, and central venous pressure monitoring
- American Society of Anesthesiologists physical status II or III
Key exclusion criteria (10 listed)
- Emergency surgery or inability to complete written informed consent before surgery
- Known contraindication or serious hypersensitivity to remimazolam, another benzodiazepine, propofol, or a relevant excipient
- Preoperative shock, ongoing vasoactive drug support, or another hemodynamically unstable condition that makes either study anesthesia strategy unsafe
- Child-Pugh class C, Model for End-Stage Liver Disease score of 20 or higher, or end-stage liver disease in the investigator's judgment
- Massive ascites, recent variceal bleeding, clinically important hypersplenism with severe thrombocytopenia, or portal hypertension sufficient to substantially alter circulatory management
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 |
|---|---|---|
| RemimazolamAfter 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. | Drug | Remimazolam Maintenance Anesthesia |
| PropofolAfter 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. | Drug | Propofol Maintenance Anesthesia |
Primary outcome
Time-weighted average of mean arterial pressure below 65 mmHg during liver parenchymal transection
Time frame: From the start to the completion of liver parenchymal transection under low central venous pressure management, intraoperative
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.
7 secondary outcomes
Cumulative norepinephrine-equivalent dose during liver parenchymal transection
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
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
Time frame: From the start to the final discontinuation of the allocated maintenance anesthetic, intraoperative
Estimated intraoperative blood loss
Time frame: From surgical incision to completion of surgery, intraoperative
Number of participants receiving intraoperative red blood cell transfusion
Time frame: During surgery, intraoperative
Intraoperative red blood cell transfusion dose
Time frame: During surgery, intraoperative
Incidence of postoperative delirium (POD)
Time frame: From the end of surgery through postoperative Day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: 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.
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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.
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 Intraoperative Hypotension and Hepatectomy, run by Beijing Tsinghua Chang Gung Hospital 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 7 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 4 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhifeng Gao, MD (+86-15801249466, gzfa02461@btch.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-weighted average of mean arterial pressure below 65 mmHg during liver parenchymal transection (time frame: From the start to the completion of liver parenchymal transection under low central venous pressure management, intraoperative). 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 4 Nov 2026.