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Sugammadex vs Placebo to Prevent Residual Neuromuscular Block

Primary Purpose

General Surgery

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Sugammadex
Placebo
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for General Surgery focused on measuring Postoperative respiratory depression, Neuromuscular Agents

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic Florida
  • The University of Texas, UTHealth

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sugammadex

Placebo

Arm Description

Subjects will have Sugammadex administered after routine reversal of anesthesia is performed and patient is extubated.

Subjects will have Placebo administered after routine reversal of anesthesia is performed and patient is extubated.

Outcomes

Primary Outcome Measures

Decreased Minute Ventilation (MV)
The number of subjects who have a MV as defined as [MV <80% MV predicted (MVPRED) based on Body Surface Area]. MV (or respiratory minute volume or minute volume) is the volume of gas inhaled (inhaled minute volume) or exhaled (exhaled minute volume) from a person's lungs per minute.
Decreased Average Minute Ventilation (MV)
The number of subjects who have an average MV <80% MV predicted (MVPRED) based on Body Surface Area. MV (or respiratory minute volume or minute volume) is the volume of gas inhaled (inhaled minute volume) or exhaled (exhaled minute volume) from a person's lungs per minute.

Secondary Outcome Measures

Train of Four (TOF) Ratio
The number of subjects to have a normal TOF ratio (>0.90) indicative of full neuromuscular recovery in the Post-anesthesia care unit (PACU)

Full Information

First Posted
March 15, 2016
Last Updated
June 21, 2022
Sponsor
Mayo Clinic
Collaborators
Merck Sharp & Dohme LLC, University of Texas, Respiratory Motion, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02728726
Brief Title
Sugammadex vs Placebo to Prevent Residual Neuromuscular Block
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
Merck Sharp & Dohme LLC, University of Texas, Respiratory Motion, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
General Surgery
Keywords
Postoperative respiratory depression, Neuromuscular Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
260 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sugammadex
Arm Type
Experimental
Arm Description
Subjects will have Sugammadex administered after routine reversal of anesthesia is performed and patient is extubated.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will have Placebo administered after routine reversal of anesthesia is performed and patient is extubated.
Intervention Type
Drug
Intervention Name(s)
Sugammadex
Other Intervention Name(s)
Bridion
Intervention Description
Sugammadex will be administered intravenously at 2 mg/kg after routine reversal of anesthesia is performed and subject is extubated.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered intravenously at 2 mg/kg after routine reversal of anesthesia is performed and subject is extubated.
Primary Outcome Measure Information:
Title
Decreased Minute Ventilation (MV)
Description
The number of subjects who have a MV as defined as [MV <80% MV predicted (MVPRED) based on Body Surface Area]. MV (or respiratory minute volume or minute volume) is the volume of gas inhaled (inhaled minute volume) or exhaled (exhaled minute volume) from a person's lungs per minute.
Time Frame
15---30 minutes after Post-anesthesia care unit (PACU) arrival
Title
Decreased Average Minute Ventilation (MV)
Description
The number of subjects who have an average MV <80% MV predicted (MVPRED) based on Body Surface Area. MV (or respiratory minute volume or minute volume) is the volume of gas inhaled (inhaled minute volume) or exhaled (exhaled minute volume) from a person's lungs per minute.
Time Frame
15---30 minutes after Post-anesthesia care unit (PACU) arrival
Secondary Outcome Measure Information:
Title
Train of Four (TOF) Ratio
Description
The number of subjects to have a normal TOF ratio (>0.90) indicative of full neuromuscular recovery in the Post-anesthesia care unit (PACU)
Time Frame
upon PACU discharge, approximately 8 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J Ross Renew, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
The University of Texas, UTHealth
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Sugammadex vs Placebo to Prevent Residual Neuromuscular Block

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