Differential Effects of Remimazolam and Propofol on Dynamic Cerebral
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Differences in dynamic cerebral blood flow autoregulation
研究概览
简要总结
Cerebral autoregulation (CA) is the property of the cerebral vascular bed to maintain cerebral perfusion in the presence of changes in blood pressure. In the case of anesthesia, altered cerebral autoregulation, including altered carbon dioxide and hemodilution, can impair physiological changes in the body and lead to poor postoperative prognosis. As a novel ultra-short-acting benzodiazepines drugs, remimazolam has been accepted for induction and maintenance of clinical anesthesia. Compared to the traditional benzodiazepines drugs, remimazolam combines the safety of midazolam with the effectiveness of propofol, and also has the advantages of acting quickly, short half-life, no injection pain, slight respiratory depression, independent of liver and kidney metabolism, long-term infusion without accumulation, and has a specific antagonist: flumazenil. Our study aimed to investigate the different effects of remimazolam and propofol on dynamic cerebral blood flow autoregulation function during general anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-60 years, gender not limited
- •Patients proposed to undergo elective laparoscopic cholecystectomy under general anesthesia, with an expected operative length of approximately 1h~2h
- •Good penetration of the temporal window.
- •ASA anesthesia classification grade I to II.
- •can communicate effectively with the physician.
- •Patients were aware of and voluntarily signed the informed consent form.
排除标准
- •Relative contraindications to general anesthesia: patients with severe heart and lung function diseases.
- •History of syncope, and dizziness.
- •Patients with a history of psychiatric disorders, neurological disorders, drug abuse, or drug addiction
- •Patients with cerebrovascular or carotid artery lesions;
- •Those who are unable to cooperate in completing the test
- •Persons who have taken benzodiazepines intermittently in the last three months.
- •Those with known allergies or allergies to the test drug.
研究组 & 干预措施
Remimazolam group
- Induction of anesthesia Slowly injects remimazolam 0.4-0.6 mg/kg (about 1 minute) until loss of consciousness (LoC), if the degree of sedation is insufficient, additional remimazolam (0.05 mg/kg each time) is allowed. After the LoC, intravenous sufentanil 0.3 ~0.5ug/kg and cisatracurium besylate 0.1 mg/kg are injected intravenously. After the muscles are sufficiently relaxed and blood circulation is stable, the tracheal tube is inserted under a glide scope.
- Maintenance of anesthesia remimazolam 0.4~1.2 mg/kg/h and remifentanil 0.1~0.3 ug/kg/min are injected intravenously to maintain sedation and assistant analgesia, and cisatracurium besylate 0.02 mg/kg is allowed to add as appropriate. During the operation, the dose of anesthetic drugs is adjusted so that the fluctuation of heart rate and blood pressure did not exceed 10 %.
干预措施: Remimazolam (Drug)
Propofol group
- Induction of anesthesia Slowly injects propofol 2-4 mg/kg (about 1 min) until loss of consciousness (LoC), allowing additional propofol (0.5 mg/kg each time) if sedation is insufficient. after LoC, intravenous sufentanil 0.3 ~0.5ug/kg and cisatracurium besylate 0.1 mg/kg. after sufficient muscle relaxation and blood circulation stabilization, the tracheal tube was inserted under the sliding scope.
- Maintenance of anesthesia propofol 4~10mg/kg/h and remifentanil 0.1~0.3 ug/kg/min are injected intravenously to maintain sedation and assistant analgesia, and cisatracurium besylate 0.02 mg/kg is allowed to add as appropriate. During the operation, the dose of anesthetic drugs is adjusted so that the fluctuation of heart rate and blood pressure did not exceed 10 %.
干预措施: Propofol (Drug)
结局指标
主要结局
Differences in dynamic cerebral blood flow autoregulation
时间窗: From the time the patient enters the operating room to the time they leave the operating room, one and a half hours on average.
Comparison of the consistency, gain and phase of the transfer function parameters in the frequency range of 0.02-0.07 Hz, 0.07-0.2 Hz and 0.2-0.5 Hz for the propofol and rimazolam groups, respectively.
次要结局
- diastolic pressure(Up to 5 hours including preoperative, intraoperative, and postoperative periods)
- heart rate(Up to 5 hours including preoperative, intraoperative, and postoperative periods)
- systolic pressure(Up to 5 hours including preoperative, intraoperative, and postoperative periods)
- mean pressure(Up to 5 hours including preoperative, intraoperative, and postoperative periods)
- pulse(Up to 5 hours including preoperative, intraoperative, and postoperative periods)
- Recovery times(Up to 30 minutes after operation)
- Complication(During the perioperative period)
研究者
Fuzhou Hua
Chief Physician
Second Affiliated Hospital of Nanchang University