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

NCT05053763 | Unknown

• 1 other identifier: TianjinNK RM-ED90
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Anesthesia

Keywords

ERCP; remimazolam; alfentanil; ED90

Outcome Measures

Primary Outcomes (1)

• The number of success duodenoscopy insertion

  success duodenoscopy insertion is defined by no body movement

  1 day

Secondary Outcomes (3)

• The number of the occurrence of hypotension

  1 day

• The number of the occurrence of bradycardia

  1 day

• The number of the occurrence of injection pain

  1 day

Study Arms (2)

Experimental: age<65 group

OTHER

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

Drug: Remimazolam

Active Comparator:age ≥65 group

OTHER

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

Drug: Remimazolam

Interventions

Remimazolam 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; Experimental: age<65 group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age is between 18 and 85 years
• ASA I-III levels;
• Patients undergone elective ERCP surgery, non-intubation patients;

You may not qualify if:

• 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

Sponsors & Collaborators

• Jianbo Yu: lead

Study Sites (1)

Tianjin Nankai Hospital

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 38745175 DERIVED

MeSH Terms

Interventions

remimazolam

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: September 22, 2021
• Study Start: September 22, 2021
• Primary Completion: December 25, 2022
• Study Completion: December 25, 2022
• Last Updated: December 20, 2021

Record last verified: 2021-12

Locations

CN (1)