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Sugammadex vs Placebo to Prevent Residual Neuromuscular Block

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02728726
Recruitment Status : Completed
First Posted : April 5, 2016
Last Update Posted : December 1, 2020
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
University of Texas
Respiratory Motion, Inc.
Information provided by (Responsible Party):
J. Ross Renew, M.D., Mayo Clinic

Brief Summary:
The study is designed to determine whether patients who receive sugammadex immediately after tracheal extubation will exhibit a decrease in the incidence of postoperative residual paralysis and an associated decrease in the incidence of postoperative respiratory depression.

Condition or disease Intervention/treatment Phase
General Surgery Drug: sugammadex Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Double---Blinded, Controlled Trial to Compare the Effectiveness of Sugammadex vs. Placebo to Prevent Residual Neuromuscular Block in the Post---Anesthesia Care Unit as Evaluated With a Non---Invasive Respiratory Volume Monitor
Actual Study Start Date : June 2016
Actual Primary Completion Date : December 2019
Actual Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment group
study drug (sugammadex) administered intravenously at 2 mg/kg after routine reversal of anesthesia is performed and patient is extubated.
Drug: sugammadex
Placebo Comparator: Control group
placebo administered intravenously after routine reversal of anesthesia is performed and patient is extubated.
Drug: Placebo



Primary Outcome Measures :
  1. Determine whether patients who receive sugammadex immediately after tracheal extubation will exhibit a decrease in the incidence of postoperative residual paralysis and an associated decrease in the incidence of postoperative respiratory depression [ Time Frame: Within the first 5 minutes of arrival to recovery room ]
    Measure Train of Four by using TOF Watch device



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing surgery with general anesthesia
  • Patients weighing > or = 80 pounds
  • Patients not intubated prior to surgery
  • Patients who are able to give informed consent

Exclusion Criteria:

  • Patients unable to give informed consent.
  • Patients whose condition will not allow for placement of the electrode PadSet of ExSpiron
  • Patients who are anticipated to remain intubated in recovery period.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02728726


Locations
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United States, Florida
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
United States, Texas
The University of Texas, UTHealth
Houston, Texas, United States, 77030
Sponsors and Collaborators
Mayo Clinic
Merck Sharp & Dohme Corp.
University of Texas
Respiratory Motion, Inc.
Investigators
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Principal Investigator: J Ross Renew, MD Mayo Clinic
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Responsible Party: J. Ross Renew, M.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02728726    
Obsolete Identifiers: NCT02822001
Other Study ID Numbers: 15-008685
First Posted: April 5, 2016    Key Record Dates
Last Update Posted: December 1, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by J. Ross Renew, M.D., Mayo Clinic:
Postoperative respiratory depression
Neuromuscular Agents
Additional relevant MeSH terms:
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Delayed Emergence from Anesthesia
Postoperative Complications
Pathologic Processes