Role of Sugammadex as Reversal Agent in Patients Extubated Immediately After Isolated Coronary Artery Bypass Grafting Surgery
NCT03939923 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 84
Last updated 2023-12-27
Summary
The purpose of this study is to examine whether the use of Sugammadex will reduce time from reversal to extubation and improve other post extubation outcomes in Coronary artery bypass grafting patients. This study is a prospective, clinical interventional, randomized single blinded single-center design. The nurses in the cardiac intensive care unit will be blinded to treatment allocation (Group 1 or 2).
Conditions
- Surgery
- Coronary Artery Disease
Interventions
- DRUG
-
Rocuronium
Intubation with Rocuronium 1.0-1.2 mg/kg (vitals maintained within 20% of baseline. Subjects may be re-dosed with rocuronium at 0.1-0.4 mg/kg during the procedure.
- DRUG
-
Neostigmine
Reversal with neostigmine (0.04-0.07 mg/kg up to 5 mg maximal dosage)
- DRUG
-
Glycopyrrolate
Reversal glycopyrrolate (0.07-0.015mg/kg up to 1 mg maximal dosage)
- DRUG
-
Sugammadex
Reversal with Sugammadex (2mg/kg)
Sponsors & Collaborators
-
West Virginia University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-05-01
- Primary Completion
- 2021-07-30
- Completion
- 2021-07-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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