Effects of Remimazolam and Propofol on Anesthesia Induction

Sponsor

Zheng Guo (Other)

Overall Status

Recruiting

CT.gov ID

NCT06009055

Collaborator

(none)

Enrollment

Location

Arms

15.5

Anticipated Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes	Drug: Remimazolam Drug: Propofol	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 17, 2023

Anticipated Primary Completion Date :

Nov 30, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Remimazolam group	Drug: Remimazolam 0.3mg/kg，injection completed in 30 seconds
Active Comparator: Propofol group	Drug: Propofol 2mg/kg，injection completed in 30 seconds

Arm

Intervention/Treatment

Experimental: Remimazolam group

Drug: Remimazolam

0.3mg/kg，injection completed in 30 seconds

Active Comparator: Propofol group

Drug: Propofol

2mg/kg，injection completed in 30 seconds

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	econd of Shanxi Medical University	Taiyuan	Shanxi	China	030001

Sponsors and Collaborators

Zheng Guo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zheng Guo, professor, Second Hospital of Shanxi Medical University

ClinicalTrials.gov Identifier:

NCT06009055

Other Study ID Numbers:

hanyi20230117

First Posted:

Aug 24, 2023

Last Update Posted:

Aug 24, 2023

Last Verified:

Aug 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Propofol

Study Results

No Results Posted as of Aug 24, 2023