Skip to main content
OpenTrials
Completed

NCT Number: NCT01804205

Magnesium Sulphate and Rocuronium in Patients Over 60

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Instituto Nacional de Câncer

Rio de Janeiro, 20230130, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Magnesium sulfate

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Total recovery time of neuromuscular block (DurTOF0.9)

    Time frame: Within the surgical procedure

    Time from the start of injection of rocuronium until TOF ratio 0.9

Secondary outcomes

  1. Onset time

    Time frame: Within the surgical procedure

    Time from the start of injection of rocuronium until 95% depression of the first twitch (T1) of the TOF

  2. Clinical duration (Dur25%)

    Time frame: 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

  3. Recovery index (Dur25-75%)

    Time frame: Within the surgical procedure

    Time between 25% and 75% recovery of the initial T1 value

  4. Recovery time (Dur25%TOF0.9)

    Time frame: Within the surgical procedure

    Time between 25% recovery of the initial T1 value and a TOF ratio of 0.9

Sponsors and collaborators

Lead sponsor

Pedro Rotava

Other Gov

Collaborators

  • Instituto Nacional de Cancer, Brazil

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Mar 5, 2013
Registry last updated
Mar 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.