Study to Determine if Administration of Sugammadex Impacts Hospital Efficiency

Phase 4

Completed

• Conditions: Neuromuscular Blockade
• Interventions: Drug: Neostigmine; Drug: sugammadex; Drug: Glycopyrrolate

• Registration Number: NCT02860507
• Lead Sponsor: University of South Florida

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.

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-02
• Study First Submitted QC: 2016-08-08
• Study First Posted: 2016-08-09
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Results First Submitted: 2018-11-19
• Status Verified: 2019-04
• Results First Submitted QC: 2019-04-10
• Last Update Submitted: 2019-04-10
• Results First Posted: 2019-04-12
• Last Update Posted: 2019-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neostigmine + Glycopyrrolate	Glycopyrrolate	Neostigmine 0.06 mg/kg and Glycopyrrolate 0.04mg/kg iv
Neostigmine + Glycopyrrolate	Neostigmine	Neostigmine 0.06 mg/kg and Glycopyrrolate 0.04mg/kg iv
sugammadex	sugammadex	Sugammadex 4mg/kg

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Number of Patients Who Experience Postoperative Nausea and Vomiting, Post-operative Pain, and Post-operative Complications	through discharge from hospital, average of 72 hours