Sugammadex vs Placebo to Prevent Residual Neuromuscular Block

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2019-12-31

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.

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Detailed Description

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Conditions

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General Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sugammadex

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

Group Type EXPERIMENTAL

Sugammadex

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Sugammadex

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Bridion

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No