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Clinical Trials/NCT06565715
NCT06565715CompletedPhase 4

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

Jun Zhang1 site in 1 country70 target enrollmentStarted: August 23, 2024Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
70
Locations
1
Primary Endpoint
Hemodynamic instability score

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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.

Arms & Interventions

Remazolam group

Experimental

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

Intervention: Remimazolam (Drug)

Propofol group

Other

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

Intervention: Propofol (Drug)

Outcomes

Primary Outcomes

Hemodynamic instability score

Time Frame: 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 Outcomes

  • Cardiac index (CI)(intraoperative)
  • Systemic vascular resistance index (SVRI)(intraoperative)
  • Complications in 1 week after surgery(1 week after surgery)
  • Stroke volume variation (SVV)(intraoperative)

Investigators

Sponsor
Jun Zhang
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Jun Zhang

Professor

Fudan University

Study Sites (1)

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