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Pharmacokinetics of Sugammadex in Obese Patients During Laparoscopic Surgery
NCT05328778Phase 4
Key facts
- Status
- Completed
- Start
- Apr 2022
- Primary completion
- Jan 2025
- Countries
- 1
- Sponsor
- General Hospital of Southern Theater Command of the People's Liberation Army
- Modality
- Biodegradable Polymers, Small Molecules
- Drugs
- Sugammadex
- Conditions
- neuromuscular blockade (NMB)
01
Overview
Phase 4, open-label trial of Sugammadex in neuromuscular blockade (NMB) (3 arms), sponsored by General Hospital of Southern Theater Command of the People's Liberation Army. Primary endpoints: Plasma Concentration of Sugammadex at 8 hours and Train-of-Four (TOF) ratio of Recovery Time. Started Apr 2022; status: completed.
02
Design
3 arms- Study design
- Non-randomizedOpen-label
Normal Weight group
n=16, 18.5kg/m² ≤ BMI ≤ 24.9kg/m²
Obese group
n=16, 25≤BMI≤39.9kg/m²
Morbidly Obese group
n=16, BMI≥40kg/m²
03
Who it enrols
Patients undergoing laparoscopic or bariatric surgery with ASA physical status I-II, excluding those with neuromuscular diseases, malignant hyperthermia, or pregnant/lactating women.
04
Endpoints
Primary
Plasma Concentration of Sugammadex
Train-of-Four (TOF) ratio of Recovery Time
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