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Completed

NCT Number: NCT06565715

Effect of Remazolam on Hemodynamics During Hepatectomy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Fudan University Shanghai Cancer Center

Shanghai, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Remimazolam

Drug

Remimazolam is used for sedation during anesthetic induction and maintenance.

Other names: rebenin

Propofol

Drug

propofol is used for sedation during anesthetic induction and maintenance.

Other names: Propofol emulsion

Primary outcomes

  1. 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

  1. Cardiac index (CI)

    Time frame: intraoperative

    The parameter of CI is measured by advanced hemodynamic monitoring device.

  2. Stroke volume variation (SVV)

    Time frame: intraoperative

    The parameter of SVV is measured by advanced hemodynamic monitoring device.

  3. Systemic vascular resistance index (SVRI)

    Time frame: intraoperative

    The parameter of SVRI is measured by advanced hemodynamic monitoring device.

  4. Complications in 1 week after surgery

    Time frame: 1 week after surgery

    Complications occured within 1 week after surgery

Sponsors and collaborators

Lead sponsor

Jun Zhang

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 22, 2024
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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