Clinical trial

Effects of Remimazolam and Propofol on Heart Rate Variability in Type 2 Diabetes Patients During Anesthesia Induction

Name
hanyi20230117
Description
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.
Trial arms
Trial start
2023-09-17
Estimated PCD
2024-11-30
Trial end
2024-12-31
Status
Recruiting
Treatment
Remimazolam
0.3mg/kg,injection completed in 30 seconds
Arms:
Remimazolam group
Propofol
2mg/kg,injection completed in 30 seconds
Arms:
Propofol group
Size
80
Primary endpoint
systolic pressure (SBP)
24 hours
diastolic pressure(DBP)
24 hours
heart rate
24 hours
Heart rate variability(HRV)
24 hours
Eligibility criteria
Inclusion Criteria: * Diagnosed as type 2 diabetes according to the "Chinese Guidelines for the Prevention and Treatment of Type 2 diabetes 2020" * ASA II or III Exclusion Criteria: * 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}
Updated at
2024-01-25

1 organization

2 products

1 indication

Organization
Zheng Guo
Indication
Diabetes
Product
Propofol