Efficacy of Sugammadex for the Reversal of Moderate and Deep Rocuronium Induced Neuromuscular Block in Patients Pretreated With Magnesium Sulphate (MagSug)

NCT01440933 Phase 2 COMPLETED

Sugammadex is a new reversal agent for neuromuscular blockers (curare). It encapsulates the curare molecule and terminates immediately its action. The recommended dose is 2 mg/kg for a slight neuromuscular block and 4 mg/kg for a profound neuromuscular block. Magnesium sulphate is frequently used in perioperative medicine and it is known to reinforce the neuromuscular block induced for instance by rocuronium. The researchers want to investigate, whether higher doses of sugammadex must be given to antagonize the neuromuscular block induced by rocuronium in patients who received magnesium sulphate.

Details

Lead sponsor	University Hospital, Geneva
Phase	Phase 2
Status	COMPLETED
Enrolment	32
Start date	2011-09
Completion	2012-06

Conditions

• Neuromuscular Block

Interventions

• Magnesium Sulfate
• Placebo comparator

Primary outcomes

• Time from start administration of sugammadex to recovery T4/T1 ratio to 0.9 — Participants will be followed for the duration of hospital stay, an expected average of 2 days
  Neuromuscular function will be assessed by acceleromyography of the adductor pollicis with a TOF-Watch SX® monitor (Organon Oss, The Netherlands). After induction of anesthesia and loss of consciousness, the acceleromyograph will be calibrated using the implemented TOF-Watch SX® calibration mode 2. Train-of-four (TOF) stimulation will be used (supramaximal square wave impulse of 200 µs duration, four stimuli at two Hz, 15 seconds interval). The units of measurement are seconds and minutes. Measurement will be continued until a TOF ration of 1.0 is reached.

Countries

Switzerland