Sugammadex vs Placebo to Prevent Residual Neuromuscular Block

Mayo Clinic

Status and phase: Completed; Phase 4

Conditions: General Surgery

Treatments: Drug: Placebo; Drug: Sugammadex

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02728726

15-008685

Details and patient eligibility

About

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.

Enrollment: 260 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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260 participants in 2 patient groups, including a placebo group

Sugammadex

Experimental group

Description:

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

Treatment:

Drug: Sugammadex

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo