Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-30 @ 3:37 PM
Study NCT ID:
NCT06258356
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-16
First Post:
2024-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Remimazolam in High Risk ERCP Patients
Sponsor:
National Taiwan University Hospital
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: