Magnesium Sulphate and Rocuronium in Patients Over 60

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Magnesium Sulphate on the Pharmacodynamics of Rocuronium in Patients 60 Years or Older: Randomised and Double-Blind Study

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Drug: Magnesium Sulfate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Magnesium sulfate group<br>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. | Drug: Magnesium Sulfate<br>* 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<br>|
| Placebo Comparator: Control group<br>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. | Drug: Placebo<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total recovery time of neuromuscular block (DurTOF0.9) | Time from the start of injection of rocuronium until TOF ratio 0.9 | Within the surgical procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset time | Time from the start of injection of rocuronium until 95% depression of the first twitch (T1) of the TOF | Within the surgical procedure | 
| Clinical duration (Dur25%) | Time from the start of injection of rocuronium until T1 of the TOF had recovered to 25% of the initial T1 value | Within the surgical procedure | 
| Recovery index (Dur25-75%) | Time between 25% and 75% recovery of the initial T1 value | Within the surgical procedure | 
| Recovery time (Dur25%TOF0.9) | Time between 25% recovery of the initial T1 value and a TOF ratio of 0.9 | Within the surgical procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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elderly, magnesium sulfate, rocuronium, neuromuscular block, onset time