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OpenTrials
Completed

NCT Number: NCT03116997

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

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.

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Key information

Conditions

Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Memoral Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neostigmine+glycopyrrolate

Drug

At the conclusion of surgery neuromuscular blockade reversed with neostigmine/glycopyrrolate

Sugammadex

Drug

At the conclusion of surgery neuromuscular blockade reversed with sugammadex

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Apr 17, 2017
Registry last updated
May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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