Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Sugammadex Dosing Based on IBW in Bariatric Surgery
NCT02713113Phase 3
Key facts
- Status
- Completed
- Start
- Mar 2015
- Primary completion
- Feb 2016
- Countries
- 1
- Sponsor
- Assiut University
- Modality
- Biodegradable Polymers, Small Molecules
- Drugs
- Sugammadex
- Conditions
- neuromuscular blockade (NMB)
01
Overview
Phase 3, randomised trial of Sugammadex in neuromuscular blockade (NMB) (3 arms), sponsored by Assiut University. Primary endpoint: Time to reversal of neuromuscular blockade at 2 hours. Started Mar 2015; status: completed.
02
Design
3 arms- Study design
- Randomized
1.5 mg/kg IBW
Sugammadex 1.5 mg/kg based on Ideal Body Weight
2 mg/kg IBW
Sugammadex 2 mg/kg based on Ideal Body Weight
4 mg/kg IBW
Sugammadex 4 mg/kg based on Ideal Body Weight
03
Who it enrols
Morbidly obese patients (BMI > 40) aged 18-60 scheduled for elective laparoscopic bariatric surgery under general anesthesia using rocuronium. Excludes patients with liver/renal dysfunction, disabling neuropsychiatric disorders, history of stroke/brain trauma in last 12 months, hypersensitivity to anesthetics, history of MI/CHF, difficult intubation, or NMB disorders.
04
Endpoints
Primary
Time to reversal of neuromuscular blockade
Secondary
Time to extubation
Beyond the preview
Go deeper on NCT02713113.
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 NCT02713113.