Effects of Remimazolam and Propofol on Heart Rate Variability in Type 2 Diabetes Patients During Anesthesia Induction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- diastolic pressure（DBP）
研究概览
简要总结
The patients with diabetes who underwent laparoscopic cholecystectomy in the general surgery department of the Second Hospital of Shanxi Medical University were selected. The patients who were induced by remimazolam were included in the experimental group, and the patients who were induced by propofol were included in the control group. All the selected patients had no intimate relationship. The differences of blood pressure, heart rate and heart rate variability (HRV) between the experimental group and the control group were observed. According to the literature, it is speculated that the changes of blood pressure, heart rate and HRV indexes in the experimental group are smaller than those in the control group, and the difference is statistically significant.
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
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed as type 2 diabetes according to the "Chinese Guidelines for the Prevention and Treatment of Type 2 diabetes 2020"
- •ASA II or III
排除标准
- •People who are allergic to Remimazolam
- •It is estimated that patients with difficulty in tracheal intubation (poor head and neck mobility, history of airway surgery, history of OSAHS, nail to chin distance<6cm, Malampati grade 3 and above, mouth opening<2.5cm, obesity (BMI>30kg · m-2), etc
- •Hypertension (clinically diagnosed as hypertension)
- •Patients with coronary heart disease (with typical symptoms of angina pectoris and exclusion of aortic valve disease, clear history of old myocardial infarction, clear history of acute myocardial infarction, coronary stenosis greater than or equal to 70% found by CAG)
- •Patients with arrhythmia, heart failure, renal failure, and recently taking cardiovascular active drugs
- •Endocrine diseases such as hyperthyroidism and pheochromocytoma that may affect the level of body hemodynamics
- •Ketoacidosis and lactic acidosis
- •Patients with long-term use of sedatives or antidepressants or a history of alcoholism or drug dependence
- •Asthma or reactive airway disease
- •Patients with myasthenia gravis and cognitive dysfunction cannot cooperate with this study
研究组 & 干预措施
Remimazolam group
干预措施: Remimazolam (Drug)
Propofol group
干预措施: Propofol (Drug)
结局指标
主要结局
diastolic pressure（DBP）
时间窗: 24 hours
change of diastolic blood pressure
heart rate
时间窗: 24 hours
change of heart rate
Heart rate variability（HRV）
时间窗: 24 hours
Changes of various indicators of heart rate variability
systolic pressure （SBP）
时间窗: 24 hours
Changes in systolic blood pressure
次要结局
未报告次要终点
研究者
Zheng Guo
professor
Second Hospital of Shanxi Medical University