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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