Anesthesia
Conditions
Keywords
ERCP, remimazolam, alfentanil, ED90
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.
Interventions
DRUGRemimazolam
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 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). 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.
Sponsors
Jianbo Yu
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Age is between 18 and 85 years * ASA I-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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number of success duodenoscopy insertion | 1 day | success duodenoscopy insertion is defined by no body movement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The number of the occurrence of hypotension | 1 day | hypotension is defined MAP decrease by 20% |
| The number of the occurrence of bradycardia | 1 day | bradycardia is defined lower than 50 beats / min |
| The number of the occurrence of injection pain | 1 day | injection pain is defined the patient complained of vascular pain |
Countries
China
Outcome results
None listed