Comparing Remimazolam and Propofol for Anesthesia in Diabetic Patients
Effects of Remimazolam and Propofol on Heart Rate Variability in Type 2 Diabetes Patients During Anesthesia Induction
This study tests whether remimazolam or propofol is better for keeping blood pressure and heart rate stable during surgery in people with type 2 diabetes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 30 Years to 70 Years |
| Sex | All |
| Sponsor | Second Hospital of Shanxi Medical University Academic / other |
| Locations | 1 site (Taiyuan, Shanxi) |
| Trial ID | NCT06009055 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of two anesthetic agents, remimazolam and propofol, on patients with type 2 diabetes undergoing laparoscopic cholecystectomy. Patients are divided into two groups, with one receiving remimazolam and the other receiving propofol for anesthesia induction. The study aims to observe differences in blood pressure, heart rate, and heart rate variability between the two groups to determine which agent may provide a more stable hemodynamic profile. The findings could help optimize anesthesia management in diabetic patients.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with type 2 diabetes who are classified as ASA II or III.
Not a fit: Patients with a history of severe cardiovascular issues or those who are allergic to remimazolam may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved anesthesia protocols for diabetic patients, enhancing their safety and recovery during surgery.
How similar studies have performed: While there is existing literature on the use of anesthetics in diabetic patients, this specific comparison of remimazolam and propofol is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Taiyuan, Shanxi
- econd of Shanxi Medical University — Taiyuan, Shanxi, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.