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Completed

NCT Number: NCT06714669

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

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

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Key information

Conditions

Hypotension During Surgery Cardiovascular Diseases Hypotension Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sun Yat-san University Cancer Center

Guangzhou, Guangdong, 510080, China

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Propofol

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.

Remimazolam

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.

Primary outcomes

  1. Blood pressure

    Time frame: 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.

  2. Heart rate

    Time frame: 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.

  3. Mean arterial pressure

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 3, 2024
Registry last updated
Dec 3, 2024

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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