Remimazolam in High Risk ERCP Patients

NCT ID: NCT06258356

Last Updated: 2024-02-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-15
• Study Completion Date: 2030-12-31

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.

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.

Conditions

the Severity and Duration of Intraoperative Hypotension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

patients receiving Remimazolam

Group Type: EXPERIMENTAL

Remimazolam

Intervention Type: DRUG

novel ultra-short-acting benzodiazepine-like anesthetic.

patients without Remimazolam

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

normal saline (compared to Remimazolam)

Interventions

Remimazolam

novel ultra-short-acting benzodiazepine-like anesthetic.

Intervention Type: DRUG

placebo

normal saline (compared to Remimazolam)

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

National Taiwan University Clinical Trial Center

Research Ethic Committee D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Chih-Jun Lai, MD

Role: CONTACT

littlecherrytw@gmail.com

_886-972652086

Other Identifiers

202310115MIND

Identifier Type: -

Identifier Source: org_study_id