- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01804205
Magnesium Sulphate and Rocuronium in Patients Over 60
March 12, 2018 updated by: Pedro Rotava
Effects of Magnesium Sulphate on the Pharmacodynamics of Rocuronium in Patients 60 Years or Older: Randomised and Double-Blind Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Rio de Janeiro, Brazil, 20230130
- Instituto Nacional de Câncer
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Magnesium sulfate group
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.
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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 Comparator: Control group
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.
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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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total recovery time of neuromuscular block (DurTOF0.9)
Time Frame: Within the surgical procedure
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Time from the start of injection of rocuronium until TOF ratio 0.9
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Within the surgical procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Onset time
Time Frame: Within the surgical procedure
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Time from the start of injection of rocuronium until 95% depression of the first twitch (T1) of the TOF
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Within the surgical procedure
|
Clinical duration (Dur25%)
Time Frame: Within the surgical procedure
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Time from the start of injection of rocuronium until T1 of the TOF had recovered to 25% of the initial T1 value
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Within the surgical procedure
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Recovery index (Dur25-75%)
Time Frame: Within the surgical procedure
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Time between 25% and 75% recovery of the initial T1 value
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Within the surgical procedure
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Recovery time (Dur25%TOF0.9)
Time Frame: Within the surgical procedure
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Time between 25% recovery of the initial T1 value and a TOF ratio of 0.9
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Within the surgical procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Pedro Rotava, MD, Instituto Nacional de Câncer
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Fuchs-Buder T, Claudius C, Skovgaard LT, Eriksson LI, Mirakhur RK, Viby-Mogensen J; 8th International Neuromuscular Meeting. Good clinical research practice in pharmacodynamic studies of neuromuscular blocking agents II: the Stockholm revision. Acta Anaesthesiol Scand. 2007 Aug;51(7):789-808. doi: 10.1111/j.1399-6576.2007.01352.x.
- Kussman B, Shorten G, Uppington J, Comunale ME. Administration of magnesium sulphate before rocuronium: effects on speed of onset and duration of neuromuscular block. Br J Anaesth. 1997 Jul;79(1):122-4. doi: 10.1093/bja/79.1.122.
- Czarnetzki C, Lysakowski C, Elia N, Tramer MR. Time course of rocuronium-induced neuromuscular block after pre-treatment with magnesium sulphate: a randomised study. Acta Anaesthesiol Scand. 2010 Mar;54(3):299-306. doi: 10.1111/j.1399-6576.2009.02160.x. Epub 2009 Nov 16.
- Dubois PE, Gourdin M, Jamart J, Broka SM, Eucher P, D'Hollander A. Early and late parameters describing the offset of neuromuscular blockade are highly intercorrelated. Acta Anaesthesiol Scand. 2012 Jan;56(1):76-82. doi: 10.1111/j.1399-6576.2011.02596.x.
- Rotava P, Cavalcanti IL, Barrucand L, Vane LA, Vercosa N. Effects of magnesium sulphate on the pharmacodynamics of rocuronium in patients aged 60 years and older: A randomised trial. Eur J Anaesthesiol. 2013 Oct;30(10):599-604. doi: 10.1097/EJA.0b013e328361d342.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Primary Completion (Actual)
March 1, 2012
Study Completion (Actual)
March 1, 2012
Study Registration Dates
First Submitted
February 28, 2013
First Submitted That Met QC Criteria
March 2, 2013
First Posted (Estimate)
March 5, 2013
Study Record Updates
Last Update Posted (Actual)
March 14, 2018
Last Update Submitted That Met QC Criteria
March 12, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Neoplasms by Site
- Head and Neck Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Reproductive Control Agents
- Calcium Channel Blockers
- Tocolytic Agents
- Magnesium Sulfate
Other Study ID Numbers
- MgRoc 60
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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