Effect of Remazolam on Hemodynamics During Hepatectomy

NCT06565715 | Completed Phase 4 DMC

• 1 other identifier: Remazolam-Hepatectomy
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

There is high incidence of hemodynamic instability in patients undergoing hepatectomy with low central venous pressure, especially in general anesthesia combined with epidural anesthesia. Remazolam, a new benzodiazepine, has no significant cardiovascular inhibitory effect. Investigators hypothesis that remazolam will provide better hemodynamic when compared with propofol in patients undergoing hepatectomy with general anesthesia combined with epidural anesthesia.

Conditions

Hemodynamic Instability

Outcome Measures

Primary Outcomes (1)

• Hemodynamic instability score

  The hemodynamic instability score is calculated as a weighted continuous measure ranging from 0 to 160 points, intended to reflect deviations of blood pressure and heart rate from predefined thresholds, and infusion rates of vasoactive agents and fluids.

  intraoperative

Secondary Outcomes (4)

• Cardiac index （CI）

  intraoperative

• Stroke volume variation (SVV)

  intraoperative

• Systemic vascular resistance index (SVRI)

  intraoperative

• Complications in 1 week after surgery

  1 week after surgery

Study Arms (2)

Remazolam group

EXPERIMENTAL

Remazolam group: remazolam is administered 0.3mg/kg intravenous for anesthesia induction.

Drug: Remimazolam

Propofol group

OTHER

Propofol group: propofol is administered 2mg/kg intravenous for anesthesia induction.

Drug: Propofol

Interventions

Remimazolam DRUG

Remimazolam is used for sedation during anesthetic induction and maintenance.

Also known as: rebenin

Remazolam group

Propofol DRUG

propofol is used for sedation during anesthetic induction and maintenance.

Also known as: Propofol emulsion

Propofol group

Eligibility Criteria

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

You may qualify if:

• Patients who sign informed consent and are willing to complete the study according to the plan;
• Over 18 years of age;
• ASA grade Ⅰ \~ Ⅲ;
• Elective surgery;
• General anesthesia combined with epidural anesthesia;
• Child Pugh is classified as Level A

You may not qualify if:

• Abnormal coagulation function;
• Abnormal platelet;
• A history of drug dependence;
• Neurological diseases;
• Severe sinus bradycardia (HR\<50 beats/min);
• Atrial fibrillation;
• Systolic blood pressure ≥200mmHg and/or diastolic blood pressure ≥120mmHg.
• Cardiac insufficiency.
• Child Pugh is classified as B or C.

Sponsors & Collaborators

• Jun Zhang: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

Location

Related Publications (1)

• Qian Y, Hou W, Yang L, Chen N, Zhang J. A randomized trial evaluating hemodynamics during minor hepatectomy under general anesthesia combined with thoracic epidural anesthesia: remimazolam versus propofol. BMC Anesthesiol. 2025 Aug 20;25(1):413. doi: 10.1186/s12871-025-03290-w.

  PMID: 40836208 DERIVED

MeSH Terms

Interventions

remimazolam; Propofol

Intervention Hierarchy (Ancestors)

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

Study Officials

• Jun Zhang, Professor

  Fudan University

  STUDY CHAIR

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: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: August 22, 2024
• Study Start: August 23, 2024
• Primary Completion: October 30, 2024
• Study Completion: November 8, 2024
• Last Updated: March 18, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)