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Effects of Remimazolam and Propofol on Anesthesia Induction

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06009055
Enrollment
80
Registered
2023-08-24
Start date
2023-09-17
Completion date
2024-12-31
Last updated
2024-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

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.

Interventions

DRUGRemimazolam

0.3mg/kg,injection completed in 30 seconds

DRUGPropofol

2mg/kg,injection completed in 30 seconds

Sponsors

Zheng Guo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
systolic pressure (SBP)24 hoursChanges in systolic blood pressure
diastolic pressure(DBP)24 hourschange of diastolic blood pressure
heart rate24 hourschange of heart rate
Heart rate variability(HRV)24 hoursChanges of various indicators of heart rate variability

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026