Title
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
Phase
Phase 4Lead Sponsor
Mayo ClinicStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
General SurgeryIntervention/Treatment
sugammadex ...Study Participants
260The 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.
Sugammadex will be administered intravenously at 2 mg/kg after routine reversal of anesthesia is performed and subject is extubated.
Placebo will be administered intravenously at 2 mg/kg after routine reversal of anesthesia is performed and subject is extubated.
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.
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.
| Event Type | Organ System | Event Term | Sugammadex | Placebo |
|---|
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.
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.
The number of subjects to have a normal TOF ratio (>0.90) indicative of full neuromuscular recovery in the Post-anesthesia care unit (PACU)
