The 90% Effective Dose of Remimazolam for Duodenoscopy Insertion During ERCP With Alfentanil 10µg/kg

Jianbo Yu

Status

Unknown

Conditions

Anesthesia

Treatments

Drug: Remimazolam

Study type

Interventional

Funder types

Other

Identifiers

NCT05053763

TianjinNK RM-ED90

Details and patient eligibility

About

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

Full description

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.

Enrollment

120 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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