Clinical trial NCT01804205: Magnesium Sulphate and Rocuronium in Patients Over 60
Official title: Effects of Magnesium Sulphate on the Pharmacodynamics of Rocuronium in Patients 60 Years or Older: Randomised and Double-Blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Head and Neck Cancer
Keywords: magnesium sulfate
rocuronium
neuromuscular block
onset time
elderly
Lead sponsor: Instituto Nacional de Cancer, Brazil
Sponsor class: OTHER_GOV
Collaborators: name: Instituto Nacional de Cancer, Brazil
First posted: 2013-03-05
Enrollment: 64
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Total recovery time of neuromuscular block (DurTOF0.9)
timeFrame: Within the surgical procedure
Secondary outcomes:
measure: Onset time
timeFrame: Within the surgical procedure
measure: Clinical duration (Dur25%)
timeFrame: Within the surgical procedure
measure: Recovery index (Dur25-75%)
timeFrame: Within the surgical procedure
measure: Recovery time (Dur25%TOF0.9)
timeFrame: Within the surgical procedure
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Câncer
Study officials:
affiliation: Instituto Nacional de Cancer
name: Pedro Rotava, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1093/bja/79.1.122.
citation: 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.
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. doi: 10.1111/j.1399-6576.2007.01352.x.
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.
citation: 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.