Remimazolam Versus Propofol for Maintenance of Anaesthesia During Major Hepatectomy Under Low Central Venous Pressure

NCT07789275 | Not Yet Recruiting Phase 4

• 1 other identifier: 27034-0-01
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Intraoperative Hypotension; Hepatectomy

Keywords

Remimazolam; Propofol; Major Hepatectomy; Low Central Venous Pressure; Total Intravenous Anesthesia; Mean Arterial Pressure; Time-Weighted Average; Perioperative Hemodynamics; Liver Parenchymal Transection

Outcome Measures

Primary Outcomes (1)

• 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.

  From the start to the completion of liver parenchymal transection under low central venous pressure management, intraoperative

Secondary Outcomes (6)

• Cumulative norepinephrine-equivalent dose during liver parenchymal transection

  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

  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

  From the start to the final discontinuation of the allocated maintenance anesthetic, intraoperative

• Estimated intraoperative blood loss

  From surgical incision to completion of surgery, intraoperative

• Number of participants receiving intraoperative red blood cell transfusion

  During surgery, intraoperative

Other Outcomes (9)

• Number of participants with acute kidney injury within 7 postoperative days

  From the end of surgery through postoperative Day 7

• Number of participants with grade B or C post-hepatectomy liver failure

  From postoperative day 5 through hospital discharge, assessed up to postoperative day 30

• Number of participants with severe hypotension during maintenance anesthesia

  From the start to the final discontinuation of the allocated maintenance anesthetic, intraoperative

Study Arms (2)

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.

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.

Drug: Propofol

Interventions

Remimazolam DRUG

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.

Remimazolam Maintenance Anesthesia

Propofol DRUG

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.

Propofol Maintenance Anesthesia

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead

Study Sites (1)

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, 102218, China

Location

MeSH Terms

Interventions

remimazolam; Propofol

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Zhifeng Gao, MD

CONTACT

+86-15801249466; gzfa02461@btch.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Anesthesiology Department

Study Record Dates

• First Submitted: August 21, 2026
• First Posted: August 27, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)