Effects of Remimazolam and Propofol on Anesthesia Induction

NCT ID: NCT06009055

Last Updated: 2024-01-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-17
• Study Completion Date: 2024-12-31

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.

Conditions

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Remimazolam group

Group Type: EXPERIMENTAL

Remimazolam

Intervention Type: DRUG

0.3mg/kg，injection completed in 30 seconds

Propofol group

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

2mg/kg，injection completed in 30 seconds

Interventions

Remimazolam

0.3mg/kg，injection completed in 30 seconds

Intervention Type: DRUG

Propofol

2mg/kg，injection completed in 30 seconds

Intervention Type: DRUG

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zheng Guo

OTHER

Sponsor Role: lead

Responsible Party

Zheng Guo

professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

econd of Shanxi Medical University

Taiyuan, Shanxi, China

Site Status: RECRUITING

Countries

China

Facility Contacts

zheng Guo

Role: primary

13753171979@163.com

13753171979

Other Identifiers

hanyi20230117

Identifier Type: -

Identifier Source: org_study_id