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Completed

NCT Number: NCT02860507

Study to Determine if Administration of Sugammadex Impacts Hospital Efficiency

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sugammadex

Drug

Other names: Bridion

Neostigmine

Drug

Glycopyrrolate

Drug

Primary outcomes

  1. Operating Room (OR) Turnover Time When Using Sugammadex Instead of Combination of Neostigmine and Glycopyrrolate.

    Time frame: through start of next surgery, average of 2 hours

Secondary outcomes

  1. Number of Patients Who Experience Postoperative Nausea and Vomiting, Post-operative Pain, and Post-operative Complications

    Time frame: through discharge from hospital, average of 72 hours

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 9, 2016
Registry last updated
Apr 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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