Clinical trial NCT02860507: Study to Determine if Administration of Sugammadex Impacts Hospital Efficiency
Official title: A Randomized, Blinded-assessor, Single Center Study to Determine if Administration of Sugammadex, When Used to Reverse Deep Neuromuscular Blockade (NMB) After Open Abdominal Surgery, Impacts Hospital Efficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neuromuscular Blockade
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2016-08-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective Randomized Double Blinded
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of Sugammadex in rapidly reversing deep neuromuscular blockaded (induced by rocuronium)

Detailed description: Participants in the study group will receive a single bolus of Sugammadex (4.0mg/kg) prior to extubation. In the post-anesthesia care unit (PACU), a blinded safety-assessor will use the visual analog scale to clinically assess post-operative pain. Post-operative nausea and vomiting (PONV) will be assessed using a PONV rating scale every 30 minutes until PACU discharge. All patients will be monitored with continuous pulse-oximetry.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for open ventral hernia repair or open colectomy
* ASA class I-III
* 18 years and older
* Subjects with a body mass index (BMI) of \<45kg/m2 and weight less than 150kg
* Subjects who have given written informed consent

Exclusion Criteria:

* Subjects with medical conditions and/or undergoing surgical procedures that are not compatible with the use of the TOF-Watch® SX (e.g., injuries to the thumbs/distal forearms, bilateral ulnar nerve damage or subjects with cardiac pacemaker
* Subjects known or suspected to have neuromuscular disorders impairing neuromuscular blockade (e.g., subjects with myasthenia gravis)
* Subjects known or suspected to have significant renal dysfunction (e.g. creatinine clearance \< 30 mL.min-1
* Subjects known or suspected to have a (family)history of malignant hyperthermia; have significant hepatic dysfunction
* Subjects known or suspected to have an allergy to opiates/opioids, muscle relaxants or other medications used during general anesthesia;
* Subjects known or suspected to be hypersensitive to Sugammadex or other cyclodextrins or Rocuronium or any of its excipients
* Subjects who have a contraindication to, Rocuronium or Sugammadex
* Female subjects who are pregnant
* Morbidly obese subjects with a BMI \> 45 kg/m2 or weight more than 150 kg

Primary outcomes:
measure: Operating Room (OR) Turnover Time When Using Sugammadex Instead of Combination of Neostigmine and Glycopyrrolate.
timeFrame: through start of next surgery, average of 2 hours
Secondary outcomes:
measure: Number of Patients Who Experience Postoperative Nausea and Vomiting, Post-operative Pain, and Post-operative Complications
timeFrame: through discharge from hospital, average of 72 hours
Other outcomes:
Locations:
Study officials:
References:
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