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Sugammadex Dose-Finding for Reversal of Rocuronium or Vecuronium in Caucasians
NCT00552929Phase 2
Key facts
- Status
- Completed
- Start
- Oct 2005
- Primary completion
- Sep 2006
- Sponsor
- Merck & Co.
- Modality
- Biodegradable Polymers, Small Molecules
- Drugs
- Sugammadex
- Conditions
- neuromuscular blockade (NMB)
01
Overview
Phase 2, randomised, open-label trial of Sugammadex in neuromuscular blockade (NMB) (10 arms), sponsored by Merck & Co. Primary endpoint: Time From Start of Sugammadex Administration to Recovery of the Neuromuscular Response to a Ratio of 0.9 for Train-Of-Four (TOF) Stimulation. Started Oct 2005; status: completed.
02
Design
10 arms- Study design
- RandomizedOpen-label
Sugammadex 0.5 mg/kg (Rocuronium)
Sugammadex 0.5 mg/kg after Rocuronium
Sugammadex 1.0 mg/kg (Rocuronium)
Sugammadex 1.0 mg/kg after Rocuronium
Sugammadex 2.0 mg/kg (Rocuronium)
Sugammadex 2.0 mg/kg after Rocuronium
Sugammadex 4.0 mg/kg (Rocuronium)
Sugammadex 4.0 mg/kg after Rocuronium
Sugammadex 8.0 mg/kg (Rocuronium)
Sugammadex 8.0 mg/kg after Rocuronium
Sugammadex 0.5 mg/kg (Vecuronium)
Sugammadex 0.5 mg/kg after Vecuronium
4 more in the full profile.
03
Who it enrols
Caucasian participants aged 20-65 scheduled for elective surgery under sevoflurane anesthesia requiring neuromuscular blockade.
04
Endpoints
Primary
Time From Start of Sugammadex Administration to Recovery of the Neuromuscular Response to a Ratio of 0.9 for Train-Of-Four (TOF) Stimulation
Secondary
Time From Start of Sugammadex Administration to a T4/T1 Recovery Ratio of 0.7
Time From Start of Sugammadex Administration to a T4/T1 Recovery Ratio of 0.8
Number of Participants With An Adverse Event (AE)
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