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Effective Dose of Remiazolam Tosylate Combined With Propofol in Upper Gastrointestinal Endoscopy Sedation: a Dose-determination Study Using Dixon's Up-and-down Method
This study used sequential method(Dixon's up and douwn) to determine the effective dose of remiazolam combined with propofol in painless upper gastrointestinal endoscopy
Remimazolam tosylate is a novel benzodiazepine drug that can be used for gastrointestinal sedation. However, some studies have reported that the sedative effect of using remimazolam alone is poor, and the patient's body movements are obvious, which affects the operation of endoscopists. Propofol, as a commonly used sedative drug, has good sedative effects, but has a high incidence of adverse events, especially cardiovascular system inhibition. Therefore, this study will explore the effective dose of remimazolam combined with propofol, reduce the adverse events of propofol and increase the sedative efficacy of remimazolam. This study only set up one study group, fixed the dosage of propofol, adjusted the dosage of Remimazolam to meet the appropriate sedation requirements for patients. Patients with successful sedation were judged to have a negative reaction, while patients with failed sedation were judged to have a positive reaction. A sequential chart was drawn based on the sedation situation until 7 positive negative reaction intersections were found, and the study ended
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Start Date
June 1, 2023
Primary Completion Date
June 12, 2023
Completion Date
June 30, 2023
Last Updated
August 1, 2023
22
ACTUAL participants
Remimazolam tosilate
DRUG
Lead Sponsor
Sichuan Provincial People's Hospital
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT06432309