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NCT05876793 | COMPLETED | Effect of Drug

Effective Dose of Remimazolam Combined With Propofol in Painless Gastroscopy
Sponsor:

Sichuan Provincial People's Hospital

Information provided by (Responsible Party):

Mend the

Brief Summary:

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

Condition or disease

Effect of Drug

Intervention/treatment

Remimazolam tosilate

Phase

NA

Detailed Description:

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

Study Type : INTERVENTIONAL
Estimated Enrollment : 22 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Effective Dose of Remiazolam Tosylate Combined With Propofol in Upper Gastrointestinal Endoscopy Sedation: a Dose-determination Study Using Dixon's Up-and-down Method
Actual Study Start Date : 2023-06-01
Estimated Primary Completion Date : 2023-06-12
Estimated Study Completion Date : 2023-06-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * ASA grading I to II, with a BMI of 18 to 30 kg/m2
Exclusion Criteria
  • * Uncontrolled severe hypertension, previous history of abnormal anesthesia, unstable angina and myocardial infarction, abnormal liver and kidney function, acute upper respiratory tract infection, suspected difficulty in the airways, allergies to opioids, milk, eggs, and propofol, long-term use of sedative and analgesic drugs.
Effective Dose of Remimazolam Combined With Propofol in Painless Gastroscopy

Location Details

NCT05876793

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Locations

Not yet recruiting

China, Sichuan

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China,