Completed
Effects of Magnesium Sulphate on the Pharmacodynamics of Rocuronium in Patients 60 Years or Older: Randomised and Double-Blind Study
What is being tested
Magnesium Sulfate
+ Placebo
Drug
Who is being recruted
Neoplasms
+ Neoplasms by Site
+ Head and Neck Neoplasms
Over 60 Years
+6 Eligibility Criteria
How is the trial designed
Supportive Care Study
Placebo-ControlledPhase 1
Interventional
Study Start: September 2008
Summary
Principal SponsorPedro Rotava
Last updated: March 14, 2018
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2008
Actual date on which the first participant was enrolled.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.
Principal SponsorPedro Rotava
Last updated: March 14, 2018
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
64 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 60 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
NeoplasmsNeoplasms by SiteHead and Neck Neoplasms
Criteria
3 inclusion criteria required to participate
60 years or older
ASA physical status I-III
Scheduled for elective oncologic head and neck surgery
3 exclusion criteria prevent from participating
Patients receiving medications known to affect neuromuscular function (furosemide, aminoglycoside, anticonvulsivants, calcio channel blocker, litium, azatioprine, cyclofosfamide)
Pre-operatory serum magnesium values > 2.5 mEq/l
Severe renal insufficiency (calculated creatinine clearance < 30 ml/min)
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalIn 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.
Group II
PlaceboControls 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.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
CompletedOne Study Center