Magnesium Sulphate and Rocuronium in Patients Over 60

NCT01804205 | Completed Phase 1

• 1 other identifier: MgRoc 60
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Keywords

magnesium sulfate; rocuronium; neuromuscular block; onset time; elderly

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Onset time

  Within the surgical procedure

• Clinical duration (Dur25%)

  Within the surgical procedure

• Recovery index (Dur25-75%)

  Within the surgical procedure

• Recovery time (Dur25%TOF0.9)

  Within the surgical procedure

Study Arms (2)

Magnesium sulfate group

EXPERIMENTAL

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.

Drug: Magnesium Sulfate

Control group

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Magnesium Sulfate DRUG

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

Magnesium sulfate group

Placebo DRUG

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

Control group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• ASA physical status I-III
• Scheduled for elective oncologic head and neck surgery

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pedro Rotava: lead
• Instituto Nacional de Cancer, Brazil: collaborator

Study Sites (1)

Instituto Nacional de Câncer

Rio de Janeiro, 20230130, Brazil

Location

Related Publications (5)

• 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.

  PMID: 9301400 BACKGROUND

• 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.

  PMID: 19919585 BACKGROUND

• 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.

  PMID: 17635389 BACKGROUND

• 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.

  PMID: 22150409 BACKGROUND

• 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.

  PMID: 23635996 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Pedro Rotava, MD

  Instituto Nacional de Cancer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Mr

Study Record Dates

• First Submitted: February 28, 2013
• First Posted: March 5, 2013
• Study Start: September 1, 2008
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: March 14, 2018

Record last verified: 2018-03

Locations

BR (1)