Remimazolam in High Risk ERCP Patients

Not Applicable

Not yet recruiting

• Conditions: the Severity and Duration of Intraoperative Hypotension
• Interventions: Drug: placebo; Drug: Remimazolam

• Registration Number: NCT06258356
• Lead Sponsor: National Taiwan University Hospital

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.

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-02-06
• Study First Submitted QC: 2024-02-13
• Study First Posted: 2024-02-14
• Last Update Submitted: 2024-02-14
• Study Start: 2024-02-15
• Last Update Posted: 2024-02-16
• Primary Completion: 2028-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patients without Remimazolam	placebo	-
patients receiving Remimazolam	Remimazolam	-

Primary Outcome Measures

Name	Time	Method
the duration and severity of hypotension checklist	1 day (during the ERCP examination)	during the ERCP examination