What this study is
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 Fairview Hospital.
What's being tested
- 2 mg/kg sugammadex
Intervention · DRUG
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
Intervention · DRUG
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).
Study details
- Official title
- Comparison of Efficacy of Sugammadex Versus Neostigmine in Reversing Neuromuscular Blocks in Patients Having Outpatient Endoscopic Retrograde Cholangiopancreatography (ERCP). A Randomized, Double-Blinded Trial
- Sponsor
- The Cleveland Clinic
- Conditions
- Neuromuscular Blocks
- Enrolling
- 80 people
- Starts
- 2024-06-01
- Est. completion
- 2026-12-31
- Design
- Double-blind, randomized, parallel groups, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- ≥18 years old
- American Society of Anesthesiologist physical status 3-4
- Scheduled for outpatient endoscopic retrograde cholangiopancreatography
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openCleveland Clinic Fairview Hospital
Cleveland, Ohio, United States
- Erica Linna, RN · Contact216-492-0186Linnae@ccf.org
- Sabry Ayad, MD · Principal investigator
Recruiting
Study team
Sponsor
The Cleveland Clinic
Study ID 23-378
Principal investigator
Ryu Komatsu, MD
The Cleveland Clinic
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.