Remimazolam in High Risk ERCP Patients

Exploring the Use of Remimazolam (BYFAVO®) in Patients at High Risk for ERCP to Reduce Intraoperative Hypotension and Assess Safety and Efficacy: A Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: the Severity and Duration of Intraoperative Hypotension
• Intervention / Treatment: Drug: Remimazolam; Drug: placebo

Detailed Description

Remimazolam is a novel ultra-short-acting benzodiazepine-like anesthetic used for gastrointestinal endoscopic procedures, characterized by predictable sedation duration and rapid recovery. Propofol, commonly used in clinical practice as an intravenous anesthetic, also exhibits rapid onset, short duration, and quick recovery characteristics. To date, there is relatively limited literature comparing the likelihood of intraoperative hypotension during general anesthesia with these two agents in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP). Additionally, a comparison is needed regarding the frequency of additional sedative doses required during anesthesia induction and the occurrence of major postoperative complications, including pancreatitis.

Therefore, the investigators we conducted a randomized trial to investigate whether the administration of Remimazolam in patients undergoing high-risk ERCP could significantly reduce the occurrence of intraoperative hypotension, facilitate rapid induction, and result in fewer associated complications. The investigators aimed to enroll 60 patients with a 1:1 ratio of ASA III to IV undergoing ERCP. The investigators anticipate that Remimazolam can reduce intraoperative hypotension, acute postoperative pancreatitis, and the occurrence of major organ complications.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chih-Jun Lai, MD; Phone Number: _886-972652086; Email: littlecherrytw@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patients receiving Remimazolam	Drug: Remimazolam; novel ultra-short-acting benzodiazepine-like anesthetic.
Placebo Comparator: patients without Remimazolam	Drug: placebo; normal saline (compared to Remimazolam)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the duration and severity of hypotension checklist	during the ERCP examination	1 day (during the ERCP examination)

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): February 15, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: February 6, 2024
• First Submitted That Met QC Criteria: February 13, 2024
• First Posted (Actual): February 14, 2024

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: 202310115MIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: due to patients' privacy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No