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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase

Completed

Phase 3

Conditions

Surgery

Treatments

Drug: Sugammadex

Drug: Neostigmine+glycopyrrolate

Study type

Interventional

Funder types

Other

Identifiers

NCT03116997

17-207

Details and patient eligibility

About

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.

Enrollment

201 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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