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Sugammadex for Reversal of Rocuronium in Surgical Patients with Pulmonary Disease
NCT00475215Phase 3
Key facts
- Status
- Completed
- Start
- Oct 2005
- Primary completion
- Aug 2006
- Sponsor
- Merck & Co.
- Modality
- Biodegradable Polymers, Small Molecules
- Drugs
- Sugammadex
- Conditions
- neuromuscular blockade (NMB)
01
Overview
Phase 3, randomised, single-blind trial of Sugammadex in neuromuscular blockade (NMB) (2 arms), sponsored by Merck & Co. Primary endpoints: Time From Start of Sugammadex Administration to Recovery of T4/T1 Ratio to 0.9 up to 90 minutes and Percentage of Participants Experiencing ≥1 Adverse Event(s) up to 7 days. Started Oct 2005; status: completed.
02
Design
2 arms- Study design
- RandomizedSingle-blind
Sugammadex 2.0 mg/kg
Sugammadex 2.0 mg/kg IV after rocuronium
Sugammadex 4.0 mg/kg
Sugammadex 4.0 mg/kg IV after rocuronium
03
Who it enrols
Adult surgical patients (ASA 1-3) with a history of pulmonary disease scheduled for general anesthesia requiring rocuronium.
04
Endpoints
Primary
Time From Start of Sugammadex Administration to Recovery of T4/T1 Ratio to 0.9
Percentage of Participants Experiencing ≥1 Adverse Event(s)
Secondary
Time From Start of Sugammadex Administration to Recovery of T4/T1 Ratio to 0.7
Time From Start of Sugammadex Administration to Recovery of T4/T1 Ratio to 0.8
Level of Consciousness Assessment
Five-Second Head Lift Assessment
General Muscle Weakness Assessment
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