Study of Recovery of Strength After Surgery Comparing Two Different Medications for Reversal of Muscle Relaxant
Overview
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.
Full Title of Study: “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”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Outcomes Assessor)
- Study Primary Completion Date: March 3, 2022
Interventions
- Drug: Neostigmine+glycopyrrolate
- At the conclusion of surgery neuromuscular blockade reversed with neostigmine/glycopyrrolate
- Drug: Sugammadex
- At the conclusion of surgery neuromuscular blockade reversed with sugammadex
Arms, Groups and Cohorts
- Experimental: Neuromuscular blockade reversed with neostigmine/gly
- Active Comparator: Neuromuscular blockade reversed with sugammadex
Clinical Trial Outcome Measures
Primary Measures
- Measure Participants’ Recovery Time Post-Surgery
- Time Frame: 1 day
- Determine whether SUG, as compared to NEO decreases time for patients to be ready for discharge from the PACU post-surgery.
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- German Echeverry, MD, Principal Investigator, Memorial Sloan Kettering Cancer Center
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