Study to Determine if Administration of Sugammadex Impacts Hospital Efficiency

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

Detailed Description
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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.

Official Title
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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

Conditions
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Neuromuscular Blockade

Intervention / Treatment
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* Drug: sugammadex
* Drug: Neostigmine
* Drug: Glycopyrrolate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective Randomized Double Blinded
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Neostigmine + Glycopyrrolate<br>Neostigmine 0.06 mg/kg and Glycopyrrolate 0.04mg/kg iv | Drug: Neostigmine<br> <br> Drug: Glycopyrrolate<br> <br> |
| Experimental: sugammadex<br>Sugammadex 4mg/kg | Drug: sugammadex<br> <br> * Other names: Bridion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operating Room (OR) Turnover Time When Using Sugammadex Instead of Combination of Neostigmine and Glycopyrrolate. |  | through start of next surgery, average of 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Who Experience Postoperative Nausea and Vomiting, Post-operative Pain, and Post-operative Complications |  | through discharge from hospital, average of 72 hours |