Efficacy of Sugammadex in Magnesium Pretreated Patients

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: Male

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 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Geneva
• Treatments: Magnesium Sulfate; Rocuronium

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.