Effects of Remimazolam and Propofol on Anesthesia Induction

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06009055
• Other study ID #: hanyi20230117
• Status: Recruiting
• Phase: N/A
• Start date: September 17, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Second Hospital of Shanxi Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes

Intervention

Drug:
• Remimazolam
0.3mg/kg,injection completed in 30 seconds
• Propofol
2mg/kg,injection completed in 30 seconds

Locations

Country	Name	City	State
China	econd of Shanxi Medical University	Taiyuan	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Zheng Guo

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	systolic pressure (SBP)	Changes in systolic blood pressure	24 hours
Primary	diastolic pressure(DBP)	change of diastolic blood pressure	24 hours
Primary	heart rate	change of heart rate	24 hours
Primary	Heart rate variability(HRV)	Changes of various indicators of heart rate variability	24 hours