Study of Recovery of Strength After Surgery Comparing Two Different Medications for Reversal of M… (NCT03116997) | Clinical Trial Compass
CompletedPhase 3
Study of Recovery of Strength After Surgery Comparing Two Different Medications for Reversal of Muscle Relaxant
United States201 participantsStarted 2017-04-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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