Remimazolam in High Risk ERCP Patients

NCT06258356 | Not Yet Recruiting

• 1 other identifier: 202310115MIND
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

We conducted a randomized trial to investigate whether the administration of Remimazolam in patients undergoing high-risk endoscopic retrograde cholangiopancreatography (ERCP) could significantly reduce the occurrence of intraoperative hypotension, facilitate rapid induction, and result in fewer associated complications.

Conditions

the Severity and Duration of Intraoperative Hypotension

Outcome Measures

Primary Outcomes (1)

• the duration and severity of hypotension checklist

  during the ERCP examination

  1 day (during the ERCP examination)

Study Arms (2)

patients receiving Remimazolam

EXPERIMENTAL

Drug: Remimazolam

patients without Remimazolam

PLACEBO COMPARATOR

Drug: placebo

Interventions

Remimazolam DRUG

novel ultra-short-acting benzodiazepine-like anesthetic.

patients receiving Remimazolam

placebo DRUG

normal saline (compared to Remimazolam)

patients without Remimazolam

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects aged between 20 and 90 years old;
• ASA (American Society of Anesthesiologists) class III to IV;
• Body Mass Index (BMI) between 18 and 30 kg/m².

You may not qualify if:

• Uncontrolled hypertension or hypotension, or clinically significant coronary artery atherosclerosis heart disease or heart failure;
• Severe respiratory system disorders;
• Severe sinus bradycardia, heart conduction block, frequent ventricular arrhythmias, or atrial fibrillation;
• Clinically significant coagulation disorders;
• End-stage liver failure or kidney disease requiring dialysis;
• Emergency surgery;
• Peripheral artery disease with upper limb functional impairment;
• Other conditions deemed inappropriate by the investigator, including patients with superficial pharyngeal cancer for whom rapid extubation is not suitable during ERCP.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

MeSH Terms

Interventions

remimazolam

Central Study Contacts

Chih-Jun Lai, MD

CONTACT

_886-972652086; littlecherrytw@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Ethic Committee D

Model Details: One patients receiving Remimazolam, the other patients receiving placebo

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 14, 2024
• Study Start: February 15, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: February 16, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share