Sugammadex vs Placebo to Prevent Residual Neuromuscular Block

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

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.

Study Overview

• Status: Completed
• Conditions: General Surgery
• Intervention / Treatment: Drug: Sugammadex; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 260
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Florida
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas, UTHealth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sugammadex; Subjects will have Sugammadex administered after routine reversal of anesthesia is performed and patient is extubated.	Drug: Sugammadex; Sugammadex will be administered intravenously at 2 mg/kg after routine reversal of anesthesia is performed and subject is extubated.; Other Names: Bridion
Placebo Comparator: Placebo; Subjects will have Placebo administered after routine reversal of anesthesia is performed and patient is extubated.	Drug: Placebo; Placebo will be administered intravenously at 2 mg/kg after routine reversal of anesthesia is performed and subject is extubated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	15---30 minutes after Post-anesthesia care unit (PACU) arrival
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.	15---30 minutes after Post-anesthesia care unit (PACU) arrival

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	upon PACU discharge, approximately 8 hours

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Merck Sharp & Dohme LLC; University of Texas; Respiratory Motion, Inc.
• Investigators: Principal Investigator: J Ross Renew, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: March 15, 2016
• First Submitted That Met QC Criteria: April 4, 2016
• First Posted (Estimate): April 5, 2016

Study Record Updates

• Last Update Posted (Actual): July 14, 2022
• Last Update Submitted That Met QC Criteria: June 21, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Postoperative respiratory depression; Neuromuscular Agents
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Delayed Emergence from Anesthesia
• Other Study ID Numbers: 15-008685

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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