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. 2017 Aug 14;2017(8):CD012763. doi: 10.1002/14651858.CD012763

NCT03116997.

Trial name or title Study of recovery of strength after surgery comparing two different medications for reversal of muscle relaxant
Methods Allocation: randomized
Intervention model: parallel assignment
Masking: participant, outcomes assessor
Primary purpose: treatment
Participants Estimated enrolment: 202
Inclusion criteria:
  • ≥ 18 years of age and capable of giving consent

  • Undergoing surgical procedures with expected length of 6 or fewer hours requiring NMB


Exclusion criteria:
  • Pregnancy

  • History of documented anaphylaxis or contraindication to any of the study medications

  • Surgical procedure for which both arms are required to be tucked at the patient's side

  • Active coronary disease with a positive cardiac stress test

  • History of severe chronic obstructive pulmonary disease (COPD) defined as FEV1 < 50% of predicted

  • Serum creatinine ≥ 2.0 mg/dL

  • Severe hepatic dysfunction accompanied by coagulopathy

  • Chronic sustained release opioid use preop for longer than 2 weeks

  • Use of toremifene

  • Significant cognitive impairment or documented psychological impairment

  • Myasthenia gravis or other neuromuscular disease

  • Not eligible for standard anaesthetic induction (e.g. needing rapid sequence induction or awake fiberoptic bronchial intubation)

  • ASA status > III

Interventions Control group:
At conclusion of surgery, neuromuscular blockade reversed with neostigmine/glycopyrrolate
Intervention group:
At conclusion of surgery, neuromuscular blockade reversed with sugammadex
Outcomes Primary outcome measures:
  • Measure participants' recovery time post surgery [Time Frame: 1 day]

  • Determine whether sugammadex as compared with neostigmine decreases time for patients to be ready for discharge from the PACU post surgery

Starting date 7 April 2017
Contact information United States, New Jersey
 Memoral Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States
 
 United States, New York 
 Memorial Sloan Kettering Cancer Center, Commack, New York, United StatesMemoral Sloan Kettering Westchester, Harrison, New York, United States
 Memorial Sloan Kettering Cancer Center, New York, New York, United States
 
 Contact: German Echeverry: echeverg@mskcc.org
Notes Currently recruiting participants. Estimated Study Completion Date: April 2019