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

Phase 3

Completed

• Conditions: Surgery
• Interventions: Drug: Neostigmine+glycopyrrolate; Drug: Sugammadex

• Registration Number: NCT03116997
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-07
• Study First Submitted: 2017-04-12
• Study First Submitted QC: 2017-04-12
• Study First Posted: 2017-04-17
• Primary Completion: 2022-03-03
• Study Completion: 2022-03-03
• Status Verified: 2023-02
• Results First Submitted: 2023-02-08
• Results First Submitted QC: 2023-02-08
• Results First Posted: 2023-03-07
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neuromuscular blockade reversed with neostigmine/gly	Neostigmine+glycopyrrolate	-
Neuromuscular blockade reversed with sugammadex	Sugammadex	-

Primary Outcome Measures

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

Trial Locations

Locations (4)

Memoral Sloan Kettering Basking Ridge; 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Commack; 🇺🇸 Commack, New York, United States

Memoral Sloan Kettering Westchester; 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States