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
Verified date | March 2018 |
Source | Instituto Nacional de Cancer, Brazil |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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) |
Country | Name | City | State |
---|---|---|---|
Brazil | Instituto Nacional de Câncer | Rio de Janeiro |
Lead Sponsor | Collaborator |
---|---|
Pedro Rotava | Instituto Nacional de Cancer, Brazil |
Brazil,
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
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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