Clinical trial NCT04969068: The Median Effective Dose of Remimazolam for Duodenoscopy Insertion During ERCP With Alfentanil 10µg/kg
Official title: The Median Effective Dose of Remimazolam for Duodenoscopy Insertion During ERCP With Alfentanil 10µg/kg
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Anesthesia
Keywords: remimazolam
alfentanil
duodenoscopy insertion
ERCP
Lead sponsor: Tianjin Nankai Hospital
Sponsor class: OTHER
First posted: 2021-07-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: OTHER

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..

Eligibility criteria: 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

Primary outcomes:
measure: The number of success duodenoscopy insertion
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Nankai Hospital
state: Tianjin
Study officials:
References: