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Completed

NCT Number: NCT02728726

Sugammadex vs Placebo to Prevent Residual Neuromuscular Block

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.

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Key information

Conditions

General Surgery

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic Florida, Jacksonville, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Sugammadex

Drug

Sugammadex will be administered intravenously at 2 mg/kg after routine reversal of anesthesia is performed and subject is extubated.

Other names: Bridion

Placebo

Drug

Placebo will be administered intravenously at 2 mg/kg after routine reversal of anesthesia is performed and subject is extubated.

Primary outcomes

  1. Decreased Minute Ventilation (MV)

    Time frame: 15---30 minutes after Post-anesthesia care unit (PACU) arrival

    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.

  2. Decreased Average Minute Ventilation (MV)

    Time frame: 15---30 minutes after Post-anesthesia care unit (PACU) arrival

    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 outcomes

  1. Train of Four (TOF) Ratio

    Time frame: upon PACU discharge, approximately 8 hours

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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Merck Sharp & Dohme LLC
  • Respiratory Motion, Inc.
  • University of Texas

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 5, 2016
Registry last updated
Jul 14, 2022

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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