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NCT01804205 Clinical Trial

Magnesium Sulphate and Rocuronium in Patients Over 60

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01804205
Other study ID # MgRoc 60
Secondary ID
Status Completed
Phase Phase 1
First received February 28, 2013
Last updated March 12, 2018
Start date September 2008
Est. completion date March 2012

Study information
Verified date March 2018
Source Instituto Nacional de Cancer, Brazil
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 64
Est. completion date March 2012
Est. primary completion date March 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Magnesium 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
• Placebo
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

Locations
Country Name City State
Brazil Instituto Nacional de Câncer Rio de Janeiro

Sponsors (2)
Lead Sponsor Collaborator
Pedro Rotava Instituto Nacional de Cancer, Brazil

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

Czarnetzki C, Lysakowski C, Elia N, Tramèr 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Total recovery time of neuromuscular block (DurTOF0.9) Time from the start of injection of rocuronium until TOF ratio 0.9 Within the surgical procedure
Secondary Onset time Time from the start of injection of rocuronium until 95% depression of the first twitch (T1) of the TOF Within the surgical procedure
Secondary Clinical duration (Dur25%) Time from the start of injection of rocuronium until T1 of the TOF had recovered to 25% of the initial T1 value Within the surgical procedure
Secondary Recovery index (Dur25-75%) Time between 25% and 75% recovery of the initial T1 value Within the surgical procedure
Secondary Recovery time (Dur25%TOF0.9) Time between 25% recovery of the initial T1 value and a TOF ratio of 0.9 Within the surgical procedure
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