Study of Recovery of Strength After Surgery Comparing Two Different Medications for Reversal of Muscle Relaxant

Study Overview
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Brief Summary
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The purpose of this study is to compare two different medications (neostigmine/glycopyrrolate and sugammadex) to see if one drug improves patient comfort regarding the return of muscle strength after surgery.

Official Title
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Randomized Controlled Assessor Blinded Clinical Trial of Sugammadex Versus Neostigmine /Glycopyrrolate for Reversal of Rocuronium Induced Neuromuscular Blockade: Time to Discharge From Post Anesthesia Care Unit and Patient Satisfaction With Recovery

Conditions
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Surgery

Intervention / Treatment
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* Drug: Neostigmine+glycopyrrolate
* Drug: Sugammadex


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients age 18 years of age or greater who are capable of giving consent Undergoing surgical procedures of expected length 6 </= hours requiring NMB Exclusion Criteria: Pregnancy History of documented anaphylaxis or contraindication to any of the study medications Active coronary disease with a positive cardiac stress test History of severe chronic obstructive pulmonary disease (COPD) defined as an FEV1 < 50% of predicted Serum Creatinine >/= 2.0 mg/dL Severe hepatic dysfunction accompanied by coagulopathy Definition: Known liver Disease AND INR > 1.5 (except for patients on anticoagulants) AND Platelet count <100,00/ul without other obvious cause Chronic sustained release opioid for > 2 weeks duration pre op (in the 30 days prior to surgery) Use of toremifene Significant cognitive impairment or documented psychologic impairment Myasthenia gravis or other neuromuscular disease Patients who are not eligible for standard anesthetic induction, eg, those needing rapid sequence induction or awake fiberoptic bronchial intubation. American Society of Anesthesiologists (ASA) Status > 3

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: Neuromuscular blockade reversed with neostigmine/gly<br> | Drug: Neostigmine+glycopyrrolate<br>* At the conclusion of surgery neuromuscular blockade reversed with neostigmine/glycopyrrolate<br>|
| Active Comparator: Neuromuscular blockade reversed with sugammadex<br> | Drug: Sugammadex<br>* At the conclusion of surgery neuromuscular blockade reversed with sugammadex<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure Participants' Recovery Time Post-Surgery | Determine whether SUG, as compared to NEO decreases time for patients to be ready for discharge from the PACU post-surgery. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neuromuscular blockade, sugammadex, SUG, neostigmine, NEO/GLYCO, 17-207