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:
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:
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 |