Comparison of Efficacy of Sugammadex Versus Neostigmine in Reversing Neuromuscular Blocks in Patients Having Outpatient Endoscopic Retrograde Cholangiopancreatography (ERCP). A Randomized, Double-Blinded Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The investigators propose a single-center,assessor-Blinded, parallel group randomized trial to compare the efficacy of reversal of rocuronium induced neuromuscular blockade by sugammadex versus neostigmine in patients undergoing Endoscopic retrograde cholangiopancreatography at Cleveland Clinic Main Campus.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• ≥18 years old
• American Society of Anesthesiologist physical status 3-4
• Scheduled for outpatient endoscopic retrograde cholangiopancreatography
Locations
United States
Ohio
Cleveland Clinic Foundation
RECRUITING
Cleveland
Contact Information
Primary
Sabry Ayad, MD
Saayad@ccf.org
216-476-7052
Backup
Sandra Durbin
durbins3@ccf.org
Time Frame
Start Date: 2024-06-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 80
Treatments
Experimental: 2 mg/kg sugammadex
All participants will be given rocuromium for neuromuscular blocks during the procedure. Per randomization, patients in this group will be reversed with 2 mg/kg sugammadex.
Active_comparator: 0.07 mg/kg neostigmine
All participants will be given rocuromium for neuromuscular blocks during the procedure. Per randomization, patients in this group will be reversed with 0.07 mg/kg neostigmine (to a maximum of 5 mg).
Related Therapeutic Areas
Sponsors
Leads: The Cleveland Clinic
Collaborators: Merck Sharp & Dohme LLC