Study to Determine if Administration of Sugammadex Impacts Hospital Efficiency

April 10, 2019 updated by: Enrico Camporesi, University of South Florida

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Neostigmine + Glycopyrrolate
Neostigmine 0.06 mg/kg and Glycopyrrolate 0.04mg/kg iv
Drug: Neostigmine
Drug: Glycopyrrolate
Experimental: sugammadex
Sugammadex 4mg/kg
Drug: sugammadex
Other Names:
  • Bridion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
through start of next surgery, average of 2 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
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
through discharge from hospital, average of 72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Florida

Collaborators

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

August 2, 2016

First Submitted That Met QC Criteria

August 8, 2016

First Posted (Estimate)

August 9, 2016

Study Record Updates

Last Update Posted (Actual)

April 12, 2019

Last Update Submitted That Met QC Criteria

April 10, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TGH015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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