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Low Dose Sugammadex Combined With Neostigmine and Glycopyrrolate Versus Full Dose Sugammadex for NMB Reversal
NCT02375217Phase 4
Key facts
- Status
- Completed
- Start
- Oct 2014
- Primary completion
- Oct 2015
- Countries
- 1
- Sponsor
- American University of Beirut Medical Center
- Modality
- Biodegradable Polymers, Small Molecules
- Drugs
- Sugammadex
- Conditions
- neuromuscular blockade (NMB)
01
Overview
Phase 4, randomised trial of Sugammadex in neuromuscular blockade (NMB) (2 arms), sponsored by American University of Beirut Medical Center. Primary endpoint: Train of Four ratio of 0.9 at 5 minutes. Started Oct 2014; status: completed.
02
Design
2 arms- Study design
- Randomized
Group 1 : (NS)
Half dose Sugammadex + Neostigmine + Glycopyrrolate
Group 2 : (S)
Full dose Sugammadex
03
Who it enrols
Adult patients (18-70 years) undergoing elective surgery under general anesthesia requiring muscle relaxants. Excludes patients with end-stage renal disease or CKD (GFR < 60), allergy to sugammadex or rocuronium, pregnant patients, and emergency surgeries.
04
Endpoints
Primary
Train of Four ratio of 0.9
Secondary
Time to return of TOF ratio to 0.9
Time till extubation
Residual neuro-muscular blockade
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