Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Sugammadex vs Neostigmine Reversal After Thoracic Anesthesia
NCT02256280Phase 4
Key facts
- Status
- Terminated
- Start
- Jan 2015
- Primary completion
- Mar 2020
- Countries
- 1
- Sponsor
- Fondazione IRCCS - Istituto Nazionale dei Tumori di Milano
- Modality
- Biodegradable Polymers, Small Molecules
- Drugs
- Sugammadex
- Conditions
- neuromuscular blockade (NMB)
01
Overview
Phase 4, randomised, double-blind trial of Sugammadex in neuromuscular blockade (NMB) (2 arms), sponsored by Fondazione IRCCS - Istituto Nazionale dei Tumori di Milano. Primary endpoint: Mean time from reversal administration to Train-of-four-ratio (TOF-ratio) = 0.9. Started Jan 2015; status: terminated.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Sugammadex
Sugammadex 2 or 4 mg/kg IV
Neostigmine
Neostigmine 0.05-0.07 mg/kg + Atropine 0.02 mg/kg IV
03
Who it enrols
Adult patients (18-70 years) scheduled for pulmonary resection or similar thoracic surgeries, with BMI 18-30. Excludes patients with severe COPD, asthma, renal failure (eGFR < 30), neuromuscular disorders, or significant cardiovascular disease.
04
Endpoints
Primary
Mean time from reversal administration to Train-of-four-ratio (TOF-ratio) = 0.9
Secondary
Mean time from reversal administration to TOF-ratio = 1.0
Mean time from reversal administration to extubation
Muscular weakness incidence
Hypoxemia or hypercapnia incidence
Adverse events incidence
Postoperative complications incidence
Beyond the preview
Go deeper on NCT02256280.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT02256280.