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

NCT04969068 | Unknown Phase 4

• 1 other identifier: TianjinNK RM007
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Keywords

remimazolam; alfentanil; duodenoscopy insertion; ERCP

Outcome Measures

Primary Outcomes (1)

• The number of success duodenoscopy insertion

  success duodenoscopy insertion is defined by no body movement

  1 day

Study Arms (1)

The median effective dose of remimazolam for duodenoscopy insertion with alfentanil 10µg/kg

EXPERIMENTAL

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)'

Drug: Remimazolam

Interventions

Remimazolam DRUG

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 as 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.

The median effective dose of remimazolam for duodenoscopy insertion with alfentanil 10µg/kg

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tianjin Nankai Hospital: lead

Study Sites (1)

Tianjin Nankai Hospital

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

MeSH Terms

Interventions

remimazolam

Central Study Contacts

Jianbo Yu, MD

CONTACT

86-22-27435873; yujianbo11@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 4, 2021
• First Posted: July 20, 2021
• Study Start: July 23, 2021
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: January 10, 2022

Record last verified: 2021-12

Locations

CN (1)