Comparison of General Anesthesia Hemodynamics Between R and P in Patients Undergoing Laparoscopic Hepatectomy

Comparison of General Anesthesia Hemodynamics Between Remimazolam and Propofol in Patients Undergoing Laparoscopic Hepatectomy: a Randomized, Controlled Trial.

This study is a randomized controlled trial designed to investigate the effects of two anesthetics, remimazolam and propofol, on intraoperative hemodynamics in patients undergoing laparoscopic liver resection. The experimental group receives remimazolam, while the control group receives propofol. The primary objective is to compare the hemodynamic responses of patients in both groups during the surgical procedure, aiming to provide insights into the potential differences in cardiovascular stability and anesthetic management associated with these two drugs

Study Overview

• Status: Completed
• Conditions: Hypotension During Surgery
• Intervention / Treatment: Drug: Remimazolam; Drug: propofol

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Sun Yat-san University Cancer Center

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Scheduled for LMH;
• Age 18-80 years, BMI 18-28 kg/m2;
• American Association of Anesthesiologists（ASA）I-III;
• Child-Pugh grade A or B;
• No serious heart, brain and other important organ lesions;
• Informed and consent, and signed informed consent.

Exclusion Criteria:

• ASA IV-V or Child-Pugh C;
• Left ventricular ejection fraction (EF) <30%;
• Implanted with temporary or permanent pacemakers;
• Organic heart disease;
• Uncontrolled hypertension, diabetes and other chronic diseases;
• Prolonged use of sedative and analgesic drugs (such as opioid analgesics, benzodiazepines, antianxiety, antidepressants, antipsychotics, etc.);
• Alcohol addiction;
• Allergic to benzodiazepines or propofol, or to any ingredient in the studied drug;
• Known history of allergy to other anesthetics; difficulty in airway and intubation during induction.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Arm: Remimazolam Group; Experimental Group (Remimazolam Anesthesia Arm): Patients in this arm will receive Remimazolam as the primary anesthetic agent for inducing and maintaining general anesthesia. The specific dosing regimen and administration protocol for Remimazolam will be determined based on the patient's characteristics and the surgical procedure being performed. Close monitoring of the patient's vital signs, particularly hemodynamic parameters, will be conducted throughout the anesthesia period to ensure safety and efficacy.	Drug: Remimazolam; Experimental Group (Remimazolam Anesthesia Arm): Patients in this arm will receive Remimazolam as the primary anesthetic agent for inducing and maintaining general anesthesia. Remimazolam belongs to a new class of benzodiazepines and acts by enhancing the activity of GABAA receptors, leading to sedation and anesthesia. The specific dosing regimen and administration protocol for Remimazolam will be determined based on the patient's characteristics and the surgical procedure being performed. Close monitoring of the patient's vital signs, particularly hemodynamic parameters, will be conducted throughout the anesthesia period to ensure safety and efficacy.
Active Comparator: Control Arm: Propofol Group; Control Group (Propofol Anesthesia Arm): Patients in this arm will receive Propofol as the primary anesthetic agent for general anesthesia. Propofol is a well-established anesthetic drug commonly used in clinical practice for its rapid onset and short duration of action. Similar to the experimental group, the dosing regimen and administration protocol for Propofol will be tailored to the individual patient's needs and the surgical procedure. Hemodynamic stability and other vital signs will also be closely monitored in this group to assess the safety and effectiveness of Propofol in comparison to Remimazolam.	Drug: propofol; Control Group (Propofol Anesthesia Arm): Patients in this arm will receive Propofol as the primary anesthetic agent for general anesthesia. Propofol is a well-established anesthetic drug commonly used in clinical practice for its rapid onset and short duration of action. Similar to the experimental group, the dosing regimen and administration protocol for Propofol will be tailored to the individual patient's needs and the surgical procedure. Hemodynamic stability and other vital signs will also be closely monitored in this group to assess the safety and effectiveness of Propofol in comparison to Remimazolam.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	The primary focus is to evaluate and compare the impact of Remimazolam and Propofol on hemodynamic parameters such as blood pressure (both systolic and diastolic). The objective is to assess whether Remimazolam causes less hemodynamic fluctuation compared to Propofol during the induction and maintenance of general anesthesia.	From enrollment to the end of treatment at 4 weeks
Heart rate	The primary focus is to evaluate and compare the impact of Remimazolam and Propofol on hemodynamic parameters such as heart rate. The objective is to assess whether Remimazolam causes less hemodynamic fluctuation compared to Propofol during the induction and maintenance of general anesthesia.	From enrollment to the end of treatment at 4 weeks
Mean arterial pressure	The primary focus is to evaluate and compare the impact of Remimazolam and Propofol on hemodynamic parameters such as mean arterial pressure. The objective is to assess whether Remimazolam causes less hemodynamic fluctuation compared to Propofol during the induction and maintenance of general anesthesia.	From enrollment to the end of treatment at 4 weeks

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2024
• Primary Completion (Actual): October 20, 2024
• Study Completion (Actual): October 30, 2024

Study Registration Dates

• First Submitted: November 22, 2024
• First Submitted That Met QC Criteria: November 28, 2024
• First Posted (Actual): December 3, 2024

Study Record Updates

• Last Update Posted (Actual): December 3, 2024
• Last Update Submitted That Met QC Criteria: November 28, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: general anesthesia; hemodynamics; propofol; hypotension; remimazolam
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypotension; Physiological Effects of Drugs; Anesthetics; Central Nervous System Depressants; Hypnotics and Sedatives; Anesthetics, Intravenous; Anesthetics, General; Propofol
• Other Study ID Numbers: Zhongguo Zhou

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No