Electroencephalographic Profiles During General Anesthesia: a Comparative Study of Remimazolam and Propofol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- EEG waveforms
研究概览
简要总结
How anesthetic drugs induce and maintain the behavioral state of general anesthesia is an important question in medicine and neuroscience. Different anesthetic drugs act on different molecular targets and neural circuit mechanisms, exhibiting drug-specific EEG features. 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. This study aimed to investigate the differences in the characteristics of EEG oscillations during general anesthesia by comparing propofol and remimazolam.
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
- •Right-handed, age 18-60 years, sex not limited.
- •Patients proposed to undergo elective laparoscopic cholecystectomy under general anesthesia in the morning, with an expected operative duration of approximately 1h to 2h.
- •Body mass index (BMI) <28 kg/m
- •Anxiety score >50, both without anxiety and sleep disorders.
- •ASA anesthesia classification grade I with Mallampati class I airway anatomy.
- •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 cardiac or pulmonary function disease.
- •Patients taking drugs that may confound EEG or behavioral findings or during pregnancy.
- •Patients with a history of psychiatric or neurological disorders, drug abuse, or drug addiction.
- •Any cerebrovascular accident within 3 months, such as stroke, transient ischemic attack (TIA), etc.;
- •Inability to cooperate in completing the test, or refusal of the patient or family members to participate.
- •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
EEG waveforms
时间窗: Duration from the time the patient enters the operating room to the time they leave the post-anesthesia care unit, average two hours.
Contrasting differences in electroencephalographic oscillatory characteristics during general anesthesia with propofol and remimazolam.
次要结局
- pulse(Up to 5 hours including preoperative, intraoperative, and postoperative periods)
- Recovery times(Up to 30 minutes after operation)
- diastolic pressure(Up to 5 hours including preoperative, intraoperative, and postoperative periods)
- heart rate(Up to 5 hours including preoperative, intraoperative, and postoperative periods)
- mean pressure(Up to 5 hours including preoperative, intraoperative, and postoperative periods)
- systolic pressure(Up to 5 hours including preoperative, intraoperative, and postoperative periods)
- Complication(During the perioperative period)
研究者
Fuzhou Hua
Chief Physician
Second Affiliated Hospital of Nanchang University