NCT06258356

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Remimazolam	novel ultra-short-acting benzodiazepine-like anesthetic.
DRUG	placebo	normal saline (compared to Remimazolam)

Timeline

• Start date: 2024-02-15
• Primary completion: 2028-12-31
• Completion: 2030-12-31
• First posted: 2024-02-14
• Last updated: 2024-02-16