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

NCT ID: NCT05053763

Last Updated: 2021-12-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-22
• Study Completion Date: 2022-12-25

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.

Conditions

Anesthesia

Keywords

ERCP; remimazolam; alfentanil; ED90

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental: age<65 group

The 90% effective dose of remimazolam for duodenoscopy insertion with alfentanil 10µg/kg

Group Type: OTHER

Remimazolam

Intervention Type: DRUG

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.

Active Comparator:age ≥65 group

The 90% effective dose of remimazolam for duodenoscopy insertion with alfentanil 10µg/kg

Group Type: OTHER

Remimazolam

Intervention Type: DRUG

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.

Interventions

Remimazolam

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jianbo Yu

OTHER

Sponsor Role: lead

Responsible Party

Jianbo Yu

Director

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Tianjin Nankai Hospital

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Yu Jianbo, Professor

Role: primary

References

Guo Y, Dong SA, Shi J, Chen HR, Liu SS, Wu LL, Wang JH, Zhang L, Li HX, Yu JB. The 90% effective dose (ED90) of remimazolam for inhibiting responses to the insertion of a duodenoscope during ERCP. BMC Anesthesiol. 2024 May 14;24(1):174. doi: 10.1186/s12871-024-02554-1.

Reference Type: DERIVED

PMID: 38745175 (View on PubMed)

Other Identifiers

TianjinNK RM-ED90

Identifier Type: -

Identifier Source: org_study_id