Status:
COMPLETED
Efficacy of Sugammadex in Magnesium Pretreated Patients
Lead Sponsor:
University Hospital, Geneva
Conditions:
Neuromuscular Block
Eligibility:
MALE
18-60 years
Phase:
PHASE2
Brief Summary
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 neuromus...
Detailed Description
Neuromuscular blocking agents (NMBAs) are frequently used in anaesthesia and intensive care medicine for tracheal intubation, artificial ventilation, and continued muscle relaxation during surgical in...
Eligibility Criteria
Inclusion
- Age ≥18 to 60 years, male.
- American Society of Anesthesiology \[ASA\] status I or II.
- Able to read and understand the information sheet and to sign and date the consent form.
- Scheduled for elective surgery lasting at least 60 minutes under general anaesthesia requiring neuromuscular relaxation using rocuronium bromide for endotracheal intubation.
Exclusion
- A history of allergy or hypersensitivity to rocuronium, sugammadex or magnesium
- Neuromuscular disease.
- Preoperative medications known to influence neuromuscular function (for instance, certain antibiotics \[aminoglycosides\] and anticonvulsants \[phenytoine\]).
- Electrolyte abnormalities (for instance, hypermagnaesemia).
- Hepatic dysfunction (i.e bilirubin \<1.5 upper limit normal (ULN), alanine aminotransferase (ALT) \<2.5 x ULN, aspartate aminotransferase (AST) \<2.5 x ULN)
- Renal insufficiency (i.e. Creatinine \<1.5 x ULN, creatinine clearance \<30ml/minute).
- Atrioventricular heart block
- Patients with magnesium treatment
- Patients with a body mass index \<19 or \>28 kg m-2.
- Pregnant, or intending to become pregnant, women.
- Breastfeeding women.
- Expected difficult intubation or mask ventilation.
- Patient having participated in any clinical trial within 30 days, inclusive, of signing the informed consent form of the current trial.
- Patients needing continuous or repeat rocuronium administration for surgical reasons.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01440933
Start Date
September 1 2011
End Date
June 1 2012
Last Update
July 10 2012
Active Locations (1)
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1
University Hospitals of Geneva
Geneva, Switzerland, 1211