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Effects of Remimazolam and Propofol on Anesthesia Induction

Z

Zheng Guo

Status

Enrolling

Conditions

Diabetes

Treatments

Drug: Remimazolam
Drug: Propofol

Study type

Interventional

Funder types

Other

Identifiers

NCT06009055
hanyi20230117

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

30 to 70 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

80 participants in 2 patient groups

Remimazolam group
Experimental group
Treatment:
Drug: Remimazolam
Propofol group
Active Comparator group
Treatment:
Drug: Propofol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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