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Sugammadex vs Traditional Reversal in ASA 4 Patients
NCT01761552Phase 4
Key facts
- Status
- Unknown
- Start
- Aug 2013
- Primary completion
- Dec 2015
- Countries
- 1
- Sponsor
- Hadassah Medical Organization
- Modality
- Biodegradable Polymers, Small Molecules
- Drugs
- Sugammadex
- Conditions
- neuromuscular blockade (NMB)
01
Overview
Phase 4, randomised, open-label trial of Sugammadex in neuromuscular blockade (NMB) (2 arms), sponsored by Hadassah Medical Organization. Primary endpoint: Extubation in the operating room before transfer to the PACU or ICU versus keeping the patient intubated when transferred at 24 hours. Status: unknown.
02
Design
2 arms- Study design
- RandomizedOpen-label
Sugammadex
Sugammadex Reversal
Traditional Reversal
Atropine/Neostigmine
03
Who it enrols
Adult ASA 4 or 4E patients undergoing bowel, urogenital, or orthopedic surgery under general anesthesia with neuromuscular blockade. Excludes severe renal/hepatic impairment and DNR orders.
04
Endpoints
Primary
Extubation in the operating room before transfer to the PACU or ICU versus keeping the patient intubated when transferred
Secondary
Time to extubation
Atelectasis
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