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

NCT ID: NCT06714669

Last Updated: 2024-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-20
• Study Completion Date: 2024-10-30

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

Conditions

Hypotension During Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Remimazolam

Intervention Type: DRUG

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.

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.

Group Type: ACTIVE_COMPARATOR

propofol

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Zhongguo Zhou

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sun Yat-san University Cancer Center

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

Zhongguo Zhou

Identifier Type: -

Identifier Source: org_study_id