Remimazolam vs. Propofol for Maintaining Anesthesia During Major Liver Resection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, single-center trial compares remimazolam to propofol for maintaining total intravenous anesthesia in adults undergoing major hepatectomy with low central venous pressure. Participants are randomly assigned to receive one of the two drugs, with the anesthesiologist aware of the allocation for safety, and outcomes include depth and duration of hypotension, vasopressor use, blood loss, and recovery through day 30. All participants undergo induction with a common regimen and receive continuous arterial pressure monitoring and standardized low central venous pressure management. The primary endpoint combines how deep and how long mean arterial pressure stays below 65 mmHg during liver transection under low-pressure conditions. Secondary measures cover complications, organ injury, transfusion needs, and postoperative recovery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Where it's running

• Beijing Tsinghua Changgung Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Zhifeng Gao, MD
• Email: gzfa02461@btch.edu.cn
• Phone: +86-15801249466

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.