Effects of Remimazolam and Propofol on Anesthesia Induction

Not Applicable

Recruiting

• Conditions: Diabetes
• Interventions: Drug: Remimazolam; Drug: Propofol

• Registration Number: NCT06009055
• Lead Sponsor: Zheng Guo

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-17
• Study First Submitted QC: 2023-08-23
• Study First Posted: 2023-08-24
• Study Start: 2023-09-17
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-24
• Last Update Posted: 2024-01-25
• Primary Completion: 2024-11-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remimazolam group	Remimazolam	-
Propofol group	Propofol	-

Primary Outcome Measures

Name	Time	Method
systolic pressure （SBP）	24 hours	Changes in systolic blood pressure
Heart rate variability（HRV）	24 hours	Changes of various indicators of heart rate variability
diastolic pressure（DBP）	24 hours	change of diastolic blood pressure
heart rate	24 hours	change of heart rate

Trial Locations

Locations (1)

econd of Shanxi Medical University; 🇨🇳 Taiyuan, Shanxi, China