Effect of Remazolam on Hemodynamics During Hepatectomy

Phase 4

Completed

• Conditions: Hemodynamic Instability
• Interventions: Drug: Remimazolam; Drug: Propofol

• Registration Number: NCT06565715
• Lead Sponsor: Jun Zhang

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.

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 Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-16
• Study First Submitted QC: 2024-08-19
• Study First Posted: 2024-08-22
• Study Start: 2024-08-23
• Primary Completion: 2024-10-30
• Study Completion: 2024-11-08
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remazolam group	Remimazolam	Remazolam group: remazolam is administered 0.3mg/kg intravenous for anesthesia induction.
Propofol group	Propofol	Propofol group: propofol is administered 2mg/kg intravenous for anesthesia induction.

Primary Outcome Measures

Name	Time	Method
Hemodynamic instability score	intraoperative	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.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, China

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, China