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

Phase 3

Completed

• Conditions: Hypotension During Surgery
• Interventions: Drug: Remimazolam; Drug: propofol

• Registration Number: NCT06714669
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-20
• Primary Completion: 2024-10-20
• Study Completion: 2024-10-30
• Status Verified: 2024-11
• Study First Submitted: 2024-11-22
• Study First Submitted QC: 2024-11-28
• Last Update Submitted: 2024-11-28
• Study First Posted: 2024-12-03
• Last Update Posted: 2024-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Arm: Remimazolam Group	Remimazolam	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.
Control Arm: Propofol Group	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.

Primary Outcome Measures

Name	Time	Method
Blood pressure	From enrollment to the end of treatment at 4 weeks	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.
Heart rate	From enrollment to the end of treatment at 4 weeks	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.
Mean arterial pressure	From enrollment to the end of treatment at 4 weeks	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.

Trial Locations

Locations (1)

Sun Yat-san University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China