Magnesium Sulphate and Rocuronium in Patients Over 60

Phase 1

Completed

• Conditions: Head and Neck Cancer
• Interventions: Drug: Placebo; Drug: Magnesium Sulfate

• Registration Number: NCT01804205
• Lead Sponsor: Pedro Rotava

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Study First Submitted: 2013-02-28
• Study First Submitted QC: 2013-03-02
• Study First Posted: 2013-03-05
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-12
• Last Update Posted: 2018-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Placebo	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.
Magnesium sulfate group	Magnesium Sulfate	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.

Primary Outcome Measures

Name	Time	Method
Total recovery time of neuromuscular block (DurTOF0.9)	Within the surgical procedure	Time from the start of injection of rocuronium until TOF ratio 0.9

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Instituto Nacional de Câncer; 🇧🇷 Rio de Janeiro, Brazil