Comparison of General Anesthesia Hemodynamics Between Remimazolam and Propofol in Patients Undergoing Laparoscopic Hepatectomy: a Randomized, Controlled Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Blood pressure
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
In order to ensure the management of perioperative anesthesia and the safety of patients, this study is a single-blind study, that is, anesthesiologists know what kind of anesthesia they have received, and carry out anesthesia plans for patients according to groups (group P / R). Participants and postoperative evaluators will not know the grouping of patients.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Remimazolam (Drug)
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.
干预措施: propofol (Drug)
结局指标
主要结局
Blood pressure
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Zhongguo Zhou
Clinical Professor
Sun Yat-sen University