Magnesium Sulphate and Rocuronium in Patients Over 60

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01804205

Enrollment

Registered

2013-03-05

Start date

2008-09-30

Completion date

2012-03-31

Last updated

2018-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

Keywords

magnesium sulfate, rocuronium, neuromuscular block, onset time, elderly

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.

Interventions

DRUGMagnesium Sulfate

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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
Recovery index (Dur25-75%)	Within the surgical procedure	Time between 25% and 75% recovery of the initial T1 value
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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026