Effect of Remazolam on Hemodynamics During Hepatectomy

Effect of Remazolam on Hemodynamics During Hepatectomy Under General Anesthesia Combined With Thoracic Epidural Anesthesia

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.

Study Overview

• Status: Completed
• Conditions: Hemodynamic Instability
• Intervention / Treatment: Drug: Remimazolam; Drug: Propofol

Detailed Description

Investigators plan to adopt the following strategies in the clinical study of this project: (1) To compare remazolam and propofol during anesthetic induction and maintenance; (2) Remazolam group: remazolam is administered 0.3mg/kg intravenous for anesthesia induction. Propofol group: propofol is administered 2mg/kg intravenous for anesthesia induction; (3) Epidural analgesia is used during perioperative period, and remifentanil pump injection is used during the operation to assist the subjects to tolerate the tracheal catheter; (4) the haemodynamic instability score (Hemodynamic instability score) is used to comprehensively evaluate intraoperative hemodynamic status. (5) To evaluate the incidence of postoperative complications. Through the above strategies, investigators further determine the optimization effect of remazolam, a novel benzodiazepine drug, on intraoperative hemodynamics in patients undergoing low central venous pressure hepatectomy, and further lay an empirical foundation for the routine use of remazolam in clinical hepatectomy.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Fudan University Shanghai Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remazolam group; Remazolam group: remazolam is administered 0.3mg/kg intravenous for anesthesia induction.	Drug: Remimazolam; Remimazolam is used for sedation during anesthetic induction and maintenance.; Other Names: rebenin
Other: Propofol group; Propofol group: propofol is administered 2mg/kg intravenous for anesthesia induction.	Drug: Propofol; propofol is used for sedation during anesthetic induction and maintenance.; Other Names: Propofol emulsion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac index （CI）	The parameter of CI is measured by advanced hemodynamic monitoring device.	intraoperative
Stroke volume variation (SVV)	The parameter of SVV is measured by advanced hemodynamic monitoring device.	intraoperative
Systemic vascular resistance index (SVRI)	The parameter of SVRI is measured by advanced hemodynamic monitoring device.	intraoperative
Complications in 1 week after surgery	Complications occured within 1 week after surgery	1 week after surgery

Collaborators and Investigators

• Sponsor: Jun Zhang
• Investigators: Study Chair: Jun Zhang, Professor, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2024
• Primary Completion (Actual): October 30, 2024
• Study Completion (Actual): November 8, 2024

Study Registration Dates

• First Submitted: August 16, 2024
• First Submitted That Met QC Criteria: August 19, 2024
• First Posted (Actual): August 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 17, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anesthetics; Central Nervous System Depressants; Hypnotics and Sedatives; Anesthetics, Intravenous; Anesthetics, General; Propofol
• Other Study ID Numbers: Remazolam-Hepatectomy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data sets are available from the corresponding author on reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No