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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04969068
• Other study ID #: TianjinNK RM007
• Status: Recruiting
• Phase: Phase 4
• Start date: July 23, 2021
• Est. completion date: December 30, 2021

Study information

• Verified date: December 2021
• Source: Tianjin Nankai Hospital
• Contact: Jianbo Yu, MD
• Phone: 86-22-27435873
• Email: yujianbo11[@]126.com
• Is FDA regulated: No
• Study type: Interventional

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.

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..

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Remimazolam
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.

Locations

Country	Name	City	State
China	Tianjin Nankai Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Nankai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of success duodenoscopy insertion	success duodenoscopy insertion is defined by no body movement	1 day