Magnesium Sulphate and Rocuronium in Patients Over 60

Condition(s) targeted: Head and Neck Cancer

Intervention: Magnesium Sulfate (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Pedro Rotava

Official(s) and/or principal investigator(s):
Pedro Rotava, MD, Principal Investigator, Affiliation: Instituto Nacional de Cancer

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Primary outcome: Total recovery time of neuromuscular block (DurTOF0.9)

Secondary outcome:

Onset time

Clinical duration (Dur25%)

Recovery index (Dur25-75%)

Recovery time (Dur25%TOF0.9)

Minimum age: 60 Years. Maximum age: N/A. Gender(s): Both.

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)

Instituto Nacional de Câncer, Rio de Janeiro 20230130, Brazil

Related publications:

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.

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.

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.

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.

Starting date: September 2008
Last updated: March 2, 2013