Remimazolam in High Risk ERCP Patients

Launched by NATIONAL TAIWAN UNIVERSITY HOSPITAL · Feb 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called Remimazolam in patients who are undergoing a special procedure called endoscopic retrograde cholangiopancreatography (ERCP). This procedure is considered high-risk and can sometimes lead to low blood pressure during surgery, which is known as intraoperative hypotension. The goal of the trial is to see if Remimazolam can help reduce the chances of this low blood pressure, make it easier to begin the procedure quickly, and lead to fewer complications afterward.

To participate in this study, people need to be between 20 and 90 years old and have certain health conditions that make them high-risk, as categorized by the American Society of Anesthesiologists. However, those with serious heart, lung, or blood disorders, as well as other specific health issues, would not be eligible. If someone qualifies and chooses to participate, they will receive either Remimazolam or a different treatment during their ERCP and will be monitored closely for any side effects or complications. This trial is not yet recruiting participants, but it aims to improve the safety of this important medical procedure for patients in the future.

Gender

ALL

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.