The Median Effective Dose of Remimazolam for Duodenoscopy Insertion During

Status Recruiting

Clinical Trial Summary

Remimazolam has shown promising results for sedation in colonoscopy . Alfentanil is widely used in the analgesia of ERCP . The purpose of the study was to determine the median effective dose of remimazolam for duodenoscopy insertion during ERCP with alfentanil 10µg/kg.

Clinical Trial Description

1. Title:The median effective dose of remimazolam for duodenoscopy insertion during ERCP with alfentanil 10µg/kg. 2. Research center: Single center. 3. The population of the study: Age is between 18 and 85 years; ASA I andIII levels; Patients undergone elective ERCP surgery, non-intubation patients; 4. Sample size:The sample size was decided based on that of prior literature, which had demonstrated that at least six independent pairs with success/failure duodenoscopy insertion during ERCP are required for reliable estimates of the ED50 of remimazolam with the Dixon's up-and-down method, and data from seven independent pairs of patients were collected for this study. The ED50 (95% confidence interval, CI) of remimazolam for successful duodenoscopy insertion during ERCP was calculated according to the formula of Dixon and Massey. 6. Interventions:The dose of remimazolam for each patient was determined by the response of the previously tested patients using the modified Dixon's up-and-down method.The first patient was tested at 0.2mg/kg remimazolam (0.025mg/kg as a step size). Duodenoscopy insertion was conducted when MOAA/S≤1.The response of the patients to the duodenoscopy insertion during ERCP was categorized as either 'success (no movement)' or 'failure (movement).' Movement was defined duodenoscopy insertion a failure was as gross purposeful muscular movement, coughing or vomiting occurring during or within 2 minutes of insertion of duodenoscopy. No movement was depicted when the reactions mentioned earlier were absent.If BIS>75 and MOAA/S > 1 when 3 min after the intravenous injection of remimazolam, it was considered a failure, and the patient received rescue sedation.. ;

Study Design

Related Conditions & MeSH terms

Anesthesia

Clinical Trial Details

NCT number	NCT04969068
Study type	Interventional
Source	Tianjin Nankai Hospital
Contact	Jianbo Yu, MD
Phone	86-22-27435873
Email	yujianbo11@126.com
Status	Recruiting
Phase	Phase 4
Start date	July 23, 2021
Completion date	December 30, 2021

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

The Median Effective Dose of Remimazolam for Duodenoscopy Insertion During ERCP With Alfentanil 10µg/kg

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms