Effect of Remazolam on Hemodynamics During Hepatectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-23

Study Completion Date

2024-11-08

Brief Summary

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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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Detailed Description

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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.

Conditions

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Hemodynamic Instability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Remazolam group

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

Group Type EXPERIMENTAL

Remimazolam

Intervention Type DRUG

Remimazolam is used for sedation during anesthetic induction and maintenance.

Propofol group

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

Group Type OTHER

Propofol

Intervention Type DRUG

propofol is used for sedation during anesthetic induction and maintenance.

Interventions

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Remimazolam

Remimazolam is used for sedation during anesthetic induction and maintenance.

Intervention Type DRUG

Propofol

propofol is used for sedation during anesthetic induction and maintenance.

Intervention Type DRUG

Other Intervention Names

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rebenin Propofol emulsion

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No