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

Phase 4

• Conditions: Anesthesia
• Interventions: Drug: Remimazolam

• Registration Number: NCT04969068
• Lead Sponsor: Tianjin Nankai Hospital

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2021-07-04
• Study First Submitted QC: 2021-07-19
• Study First Posted: 2021-07-20
• Study Start: 2021-07-23
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-16
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30
• Last Update Posted: 2022-01-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Age is between 18 and 85 years
• ASA I and III, levels;
• Patients undergone elective ERCP surgery, non-intubation patients;

Exclusion Criteria

• Chronic pain with long-term use of analgesics, psychotropic substances (including opioids, NSAIDs, sedatives, antidepressants), alcohol abusers, with known drug allergy;
• BMI<18,BMI>30
• Abnormal renal function (BUN or Cr ) ;
• Previous abnormal surgical anesthesia recovery history;
• Hypertension or systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 95 mmHg when the patient admission to the operating room
• Suffering from esophageal reflux; • Sedatives, analgesics and antipruritic drugs were used 24 hours before operation;
• Expected difficult intubation ;
• Liver surgery history;
• Opioids allergy history;
• Take monoamine oxidase inhibitor or antidepressant within 15 days;
• COPD;
• Pregnant or parturient women;
• Involved in other drug trials within three months;
• Patients who can not communicate well with the researcher

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
The median effective dose of remimazolam for duodenoscopy insertion with alfentanil 10µg/kg	Remimazolam	The first patient was tested at 0.2mg/kg remimazolam (0.025mg/kg as a step size).The response of the patients to the duodenoscopy insertion during ERCP was categorized as either 'success (no movement)' or 'failure (movement)'

Primary Outcome Measures

Name	Time	Method
The number of success duodenoscopy insertion	1 day	success duodenoscopy insertion is defined by no body movement

Trial Locations

Locations (1)

Tianjin Nankai Hospital; 🇨🇳 Tianjin, Tianjin, China