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Magnesium Sulphate and Rocuronium in Patients Over 60

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Magnesium Sulfate
Placebo
Sponsored by
Pedro Rotava
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Cancer focused on measuring magnesium sulfate, rocuronium, neuromuscular block, onset time, elderly

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Instituto Nacional de Câncer

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Magnesium sulfate group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Total recovery time of neuromuscular block (DurTOF0.9)
Time from the start of injection of rocuronium until TOF ratio 0.9

Secondary Outcome Measures

Onset time
Time from the start of injection of rocuronium until 95% depression of the first twitch (T1) of the TOF
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
Recovery index (Dur25-75%)
Time between 25% and 75% recovery of the initial T1 value
Recovery time (Dur25%TOF0.9)
Time between 25% recovery of the initial T1 value and a TOF ratio of 0.9

Full Information

First Posted
February 28, 2013
Last Updated
March 12, 2018
Sponsor
Pedro Rotava
Collaborators
Instituto Nacional de Cancer, Brazil
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1. Study Identification

Unique Protocol Identification Number
NCT01804205
Brief Title
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

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Pedro Rotava
Collaborators
Instituto Nacional de Cancer, Brazil

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
magnesium sulfate, rocuronium, neuromuscular block, onset time, elderly

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Magnesium sulfate group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Total recovery time of neuromuscular block (DurTOF0.9)
Description
Time from the start of injection of rocuronium until TOF ratio 0.9
Time Frame
Within the surgical procedure
Secondary Outcome Measure Information:
Title
Onset time
Description
Time from the start of injection of rocuronium until 95% depression of the first twitch (T1) of the TOF
Time Frame
Within the surgical procedure
Title
Clinical duration (Dur25%)
Description
Time from the start of injection of rocuronium until T1 of the TOF had recovered to 25% of the initial T1 value
Time Frame
Within the surgical procedure
Title
Recovery index (Dur25-75%)
Description
Time between 25% and 75% recovery of the initial T1 value
Time Frame
Within the surgical procedure
Title
Recovery time (Dur25%TOF0.9)
Description
Time between 25% recovery of the initial T1 value and a TOF ratio of 0.9
Time Frame
Within the surgical procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro Rotava, MD
Organizational Affiliation
Instituto Nacional de Cancer
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Nacional de Câncer
City
Rio de Janeiro
ZIP/Postal Code
20230130
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
9301400
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.
Results Reference
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PubMed Identifier
19919585
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.
Results Reference
background
PubMed Identifier
17635389
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.
Results Reference
background
PubMed Identifier
22150409
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.
Results Reference
background
PubMed Identifier
23635996
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.
Results Reference
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Magnesium Sulphate and Rocuronium in Patients Over 60

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