Magnesium Sulphate and Rocuronium in Patients Over 60

Pedro Rotava

Status and phase: Completed; Phase 1

Conditions: Head and Neck Cancer

Treatments: Drug: Magnesium Sulfate; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01804205

MgRoc 60

Details and patient eligibility

About

The purpose of this study is to evaluate the effects of MgSO4 administration on the pharmacodynamics of rocuronium in patients with 60 or more years of age.

Enrollment: 64 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 60 years or older
• ASA physical status I-III
• Scheduled for elective oncologic head and neck surgery

Exclusion criteria

• Severe renal insufficiency (calculated creatinine clearance < 30 ml/min)
• Pre-operatory serum magnesium values > 2.5 mEq/l
• Patients receiving medications known to affect neuromuscular function (furosemide, aminoglycoside, anticonvulsivants, calcio channel blocker, litium, azatioprine, cyclofosfamide)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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64 participants in 2 patient groups, including a placebo group

Magnesium sulfate group

Experimental group

Description:

In the magnesium group, patients received MgSO4 30 mg/kg in 0.9% physiological saline (total volume 100 ml) intravenously, for 10 min, and then continuous intravenous infusion of MgSO4 at a rate of 1 g/h during the surgical procedure until the maximum of 3 h.

Treatment:

Drug: Magnesium Sulfate

Control group

Placebo Comparator group

Description:

Controls received 100 ml of 0.9% physiological saline, for 10 min, and then continuous intravenous infusion of saline at a rate of 33 ml/h during the surgical procedure until the maximum of 3 h.

Treatment:

Drug: Placebo