Sugammadex vs Placebo to Prevent Residual Neuromuscular Block
NCT02728726 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 260
Last updated 2022-07-14
Summary
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.
Conditions
- General Surgery
Interventions
- DRUG
-
Sugammadex
Sugammadex will be administered intravenously at 2 mg/kg after routine reversal of anesthesia is performed and subject is extubated.
- DRUG
-
Placebo will be administered intravenously at 2 mg/kg after routine reversal of anesthesia is performed and subject is extubated.
Sponsors & Collaborators
- collaborator INDUSTRY
-
University of Texas
collaborator OTHER -
Respiratory Motion, Inc.
collaborator INDUSTRY - lead OTHER
Principal Investigators
-
J Ross Renew, MD · Mayo Clinic
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 100 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-06-30
- Primary Completion
- 2019-12-31
- Completion
- 2019-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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