Effects of Remimazolam and Propofol on Anesthesia Induction

January 24, 2024 updated by: Zheng Guo

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanxi
      • Taiyuan, Shanxi, China, 030001
        • Recruiting
        • econd of Shanxi Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
systolic pressure （SBP）
Time Frame: 24 hours
Changes in systolic blood pressure
24 hours
diastolic pressure（DBP）
Time Frame: 24 hours
change of diastolic blood pressure
24 hours
heart rate
Time Frame: 24 hours
change of heart rate
24 hours
Heart rate variability（HRV）
Time Frame: 24 hours
Changes of various indicators of heart rate variability
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zheng Guo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 17, 2023

Primary Completion (Estimated)

November 30, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

February 17, 2023

First Submitted That Met QC Criteria

August 23, 2023

First Posted (Actual)

August 24, 2023

Study Record Updates

Last Update Posted (Actual)

January 25, 2024

Last Update Submitted That Met QC Criteria

January 24, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • hanyi20230117

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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