Effects of Remimazolam and Propofol on Anesthesia Induction

NCT06009055 | Unknown

• 1 other identifier: hanyi20230117
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (4)

• systolic pressure （SBP）

  Changes in systolic blood pressure

  24 hours

• diastolic pressure（DBP）

  change of diastolic blood pressure

  24 hours

• heart rate

  change of heart rate

  24 hours

• Heart rate variability（HRV）

  Changes of various indicators of heart rate variability

  24 hours

Study Arms (2)

Remimazolam group

EXPERIMENTAL

Drug: Remimazolam

Propofol group

ACTIVE COMPARATOR

Drug: Propofol

Interventions

Remimazolam DRUG

0.3mg/kg，injection completed in 30 seconds

Remimazolam group

Propofol DRUG

2mg/kg，injection completed in 30 seconds

Propofol group

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed as type 2 diabetes according to the "Chinese Guidelines for the Prevention and Treatment of Type 2 diabetes 2020"
• ASA II or III

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Zheng Guo: lead

Study Sites (1)

econd of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

remimazolam; Propofol

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: August 24, 2023
• Study Start: September 17, 2023
• Primary Completion: November 30, 2024
• Study Completion: December 31, 2024
• Last Updated: January 25, 2024

Record last verified: 2024-01

Locations

CN (1)