Sugammadex Vs Neostigmine in Reversing Neuromuscular Blocks in Outpatient ERCP. A Randomized, Double-Blinded Trial
Recruiting
Phase 3Interventional Study
Neuromuscular Blocks
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
80 (estimated)
Sponsor
The Cleveland Clinic · Other
Who this trial is looking for
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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.
Trial Locations
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Status
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)
…
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
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