Sugammadex Vs Neostigmine in Reversing Neuromuscular Blocks in Outpatient ERCP. A Randomized, Double-Blinded Trial

Study Overview
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Brief Summary
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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 Main Campus.

Detailed Description
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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. Participating patients and outcome assessors will be blinded to group assignment. The anesthesiologists who assume anesthesia care will not be blinded to group assignment. American Society of Anesthesiologists (ASA) physical status 3 and 4 adults scheduled for elective outpatient ERCP procedure with general anesthesia at Cleveland Clinic Main Campus will be included in the study. Patients will be excluded if they have suspected difficult airway, neuromuscular disorders, end-stage renal disease requiring hemodialysis, are allergic to fentanyl, neuromuscular blocking drugs or neuromuscular reversal drugs, or are pregnant or breastfeeding. Eighty patients scheduled for outpatient ERCP with general anesthesia and rocuronium-induced muscle relaxation will be randomized 1:1 to: 1) reversal by sugammadex; or 2) reversal by neostigmine. Randomization will be stratified by 2 factors: (1) patient's age (older than 60 versus younger than 60) and (2) diagnostic vs. interventional procedures. Randomization will be based on computer generated codes that will be maintained in web-based system until shortly before induction of anesthesia, thus concealing allocation so long as practical.

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

Conditions
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Neuromuscular Blocks

Intervention / Treatment
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* Drug: 2 mg/kg sugammadex
* Drug: 0.07 mg/kg neostigmine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2 mg/kg sugammadex<br>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. | Drug: 2 mg/kg sugammadex<br>* 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.<br>* 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.;|
| Active Comparator: 0.07 mg/kg neostigmine<br>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). | Drug: 0.07 mg/kg neostigmine<br>* 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).<br>* 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).;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time required from reversal of neuromuscular block to discharge readiness | To assess the time required from reversal of neuromuscular block to discharge readiness in patients randomized to sugammadex or neostigmine. | First 24 hours after reversal of neuromuscular block | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postoperative nausea and vomiting (PONV) in patients randomized to sugammadex or neostigmine. | Incidence of postoperative nausea and vomiting (PONV) in patients randomized to sugammadex or neostigmine. | 2 hours of post anesthetic recovery |