Sugammadex vs Placebo to Prevent Residual Neuromuscular Block

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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General Surgery

Intervention / Treatment
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* Drug: Sugammadex
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative respiratory depression, Neuromuscular Agents