Effects of Remimazolam and Propofol on Anesthesia Induction

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes

Intervention / Treatment
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* Drug: Remimazolam
* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remimazolam group<br> | Drug: Remimazolam<br>* 0.3mg/kg，injection completed in 30 seconds<br>|
| Active Comparator: Propofol group<br> | Drug: Propofol<br>* 2mg/kg，injection completed in 30 seconds<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| systolic pressure （SBP） | Changes in systolic blood pressure | 24 hours | 
| diastolic pressure（DBP） | change of diastolic blood pressure | 24 hours | 
| heart rate | change of heart rate | 24 hours | 
| Heart rate variability（HRV） | Changes of various indicators of heart rate variability | 24 hours |