The 90% Effective Dose of Remimazolam for Duodenoscopy Insertion During ERCP With Alfentanil 10µg/kg
- Registration Number
- NCT05053763
- Lead Sponsor
- Jianbo Yu
- 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 90% Effective Dose of Remimazolam for Duodenoscopy Insertion During ERCP With Alfentanil 10µg/kg
- Detailed Description
1. Title:The 90% 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-III levels; Patients undergone elective ERCP surgery, non-intubation patients; 4. Sample size:The sample size was decided based on that of prior Literature.The study was carried out using a biased coin design up-and-down sequential method, where the dose of remimazolam administered to each patient depended on the response of the previous one with success/failure duodenoscopy insertion during ERCP are required for reliable estimates. The first patient recruited received a dose of 0.2mg/kg, based on our past experience.Subsequently, if a patient had a failure duodenoscopy insertion, the dose of remimazolam was increased by 0.025mg/kg in the next subject. If a patient had a successful duodenoscopy insertion the next subject was randomised to receive either a lower dose (with a decrement of 0.025mg/kg), with a probability of b = 0.11, or the same dose, with a probability of 1-b = 0.89.
We defined duodenoscopy insertion a failure was as gross purposeful muscular movement, coughing or vomiting occurring during or within 2 minutes of insertion of duodenoscopy. 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. Success was depicted when the reactions mentioned earlier were absent.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
- Age is between 18 and 85 years
- ASA I-III levels;
- Patients undergone elective ERCP surgery, non-intubation patients;
- Chronic pain with long-term use of analgesics, psychotropic substances (including opioids, NSAIDs, sedatives, antidepressants), alcohol abusers, with known drug allergy;
- BMI<18 or BMI>30;
- 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 ;
- Opioids allergy history;
- Take monoamine oxidase inhibitor or antidepressant within 15 days;
- 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
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental: age<65 group Remimazolam The 90% effective dose of remimazolam for duodenoscopy insertion with alfentanil 10µg/kg Active Comparator:age ≥65 group Remimazolam The 90% effective dose of remimazolam for duodenoscopy insertion with alfentanil 10µg/kg
- Primary Outcome Measures
Name Time Method The number of success duodenoscopy insertion 1 day success duodenoscopy insertion is defined by no body movement
- Secondary Outcome Measures
Name Time Method The number of the occurrence of bradycardia 1 day bradycardia is defined lower than 50 beats / min
The number of the occurrence of hypotension 1 day hypotension is defined MAP decrease by 20%
The number of the occurrence of injection pain 1 day injection pain is defined the patient complained of vascular pain
Trial Locations
- Locations (1)
Tianjin Nankai Hospital
🇨🇳Tianjin, Tianjin, China