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

NCT02860507.

Trial name or title Study to determine if administration of sugammadex impacts hospital efficiency
Methods Allocation: randomized
Endpoint classification: efficacy study
Intervention model: parallel assignment
Masking: double‐blind (participant, caregiver, investigator, outcomes assessor)
Primary purpose: treatment
Participants Estimated enrolment: 50
Inclusion criteria:
  • Scheduled for open ventral hernia repair or open colectomy

  • ASA class I to III

  • ≥ 18 years of age

  • Body mass index (BMI) < 45 kg/m2 and weight < 150 kg

  • Written informed consent


Exclusion criteria:
  • Medical conditions and/or surgical procedures that are not compatible with use of the TOF‐Watch SX (e.g. injuries to the thumbs/distal forearms, bilateral ulnar nerve damage, cardiac pacemaker)

  • Known or suspected neuromuscular disorders impairing neuromuscular blockade (e.g. myasthenia gravis)

  • Known or suspected significant renal dysfunction (e.g. creatinine clearance < 30 mL.min‐1)

  • Known or suspected family history of malignant hyperthermia; significant hepatic dysfunction

  • Known or suspected allergy to opiates/opioids, muscle relaxants, or other medications used during general anaesthesia

  • Known or suspected hypersensitivity to sugammadex or other cyclodextrins or rocuronium or any of its excipients

  • Contraindication to rocuronium or sugammadex

  • Pregnancy

  • Morbid obesity with BMI > 45 kg/m2 or weight > 150 kg

Interventions Neostigmine 0.06 mg/kg and glycopyrrolate 0.04 mg/kg IV
Sugammadex 4 mg/kg
Outcomes Primary outcome measures:
  • Operating room (OR) turnover time when sugammadex is used instead of combination of neostigmine and glycopyrrolate [Time Frame: through start of next surgery, average of 2 hours] [Designated as safety issue: no]


Secondary outcome measures:
  • Number of participants who experience postoperative nausea and vomiting, postoperative pain, and postoperative complications [Time Frame: through discharge from hospital, average of 72 hours] [Designated as safety issue: no]

Starting date August 2016
Contact information Enrico Camporesi, Attending Anesthesiologist & Director of Research, SE, University of South Florida
Notes This study is enrolling participants by invitation only. Estimated Primary Completion Date: May 2017