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Clinical trial

Comparison of Efficacy of Sugammadex Versus Neostigmine in Reversing Neuromuscular Blocks in Patients Having Outpatient Endoscopic Retrograde Cholangiopancreatography (ERCP). A Randomized, Double-Blinded Trial

ID
Name
23-378
Description
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.
Trial arms
Trial start
2024-05-15
Estimated PCD
2025-10-31
Trial end
2025-10-31
Status
Not yet recruiting
Treatment
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.
Arms:
2 mg/kg sugammadex
Other names:
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.
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).
Arms:
0.07 mg/kg neostigmine
Other names:
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).
Size
80
Primary endpoint
Time required from reversal of neuromuscular block to discharge readiness
First 24 hours after reversal of neuromuscular block
Eligibility criteria
Inclusion Criteria: * ≥18 years old * American Society of Anesthesiologist physical status 3-4 * Scheduled for outpatient endoscopic retrograde cholangiopancreatography Exclusion Criteria: * Difficult Airway * Neuromuscular Disorders (eg: ALS, Botulism, Myasthenia Gravis, Lambert-eaton syndrome) * End stage renal disease requiring dialysis * Pregnancy or breast-feeding * Allergy to Fentanyl * Allergy to Neuromuscular blocking drugs (eg: rocuronium) * Allergy to Neuromuscular reversal drugs (eg: sugammadex or neostigmine) * Allergy to glycopyrrolate
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'A single-center, Assessor-Blinded, parallel group randomized trial', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}
Updated at
2024-04-23

1 organization

2 products

1 indication

Organization
The Cleveland Clinic
Product
Sugammadex
Indication
Neuromuscular Blockade
Product
Neostigmine