Additional identifiers
EudraCT number
2004-002818-11
ClinicalTrials.gov number
Protocol/serial number
Version 5
Study information
Scientific title
Acronym
MAGNETS
Study hypothesis
The prophylactic perioperative correction of magnesium deficiency by infusion of magnesium sulphate to all patients presenting for thoracotomy or thoracolaparotomy for pneumonectomy, lobectomy or oesophagectomy will significantly reduce the incidence of supra-ventricular dysrhythmias post operatively.
Ethics approval
South Birmingham Research Ethics Committee. Date of approval: 04/05/2005 (ref: 05/Q2707/1)
Study design
Single-centre prospective double-blind randomised placebo-controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Supra-ventricular dysrhythmias in patients following non-cardiac thoracic surgery
Intervention
Patients are randomised into either the placebo or magnesium groups. Patients receive either placebo or 5 g magnesium sulphate infusion intra-operatively, day 1 and day 2 post-operatively. Continuous electrocardiogram (ECG) recording for 5 days will be commenced using a holter (non-invasive) recorder after induction of anaesthesia. ECG data will be analysed by a cardiac physiologist who is blinded from which treatment group the patient is in.
Intervention type
Drug
Phase
Not Specified
Drug names
Magnesium sulphate
Primary outcome measure
To demonstrate a clinically and statistically significant reduction in the incidence of postoperative supra-ventricular dysrhythmias in the patient group who have received magnesium in comparison to the placebo group. It is aimed that patients have holter monitoring for 5 days post-operatively.
Secondary outcome measures
1. Length of hospital stay
2. Thirty-day mortality
Overall trial start date
01/06/2006
Overall trial end date
30/06/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Both male and female patients
2. Above 18 years; no upper age limit
3. Patients presenting to the Department of Thoracic Surgery at Birmingham Heartlands Hospital for elective lobectomy, bi-lobectomy, pneumonectomy or oesophagectomy
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200
Participant exclusion criteria
1. Evidence of renal failure (serum creatinine of >130)
2. Liver failure
3. Pre-existing cardiac arrhythmia
4. Undergoing long-term treatment for an arrhythmia
5. On long-term treatment with nifedipine or aminoglycosides
6. Known hypersensitivity to magnesium sulphate
7. If preoperative magnesium level is equal or greater than 1.2 mmol/l
8. If they are unwilling or unable to give informed consent for their participation or if they withdraw consent
9. Patients who have participated in another interventional study within the previous 3 months
Recruitment start date
01/06/2006
Recruitment end date
30/06/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
2nd Floor
Birmingham
B5 5SS
United Kingdom
Sponsor information
Organisation
Heart of England NHS Foundation Trust (UK)
Sponsor details
Research and Development Department
1st Floor
Lincoln House
Bordesley Green East
Birmingham
B5 5SS
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
British Heart Foundation (UK)
Alternative name(s)
BHF
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both public and private)
Location
United Kingdom
Funder name
European Association of Cardiothoracic Anaesthesiologists (EACTA) (Ireland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21558066
Publication citations
-
Results
Saran T, Perkins GD, Javed MA, Annam V, Leong L, Gao F, Stedman R, Does the prophylactic administration of magnesium sulphate to patients undergoing thoracotomy prevent postoperative supraventricular arrhythmias? A randomized controlled trial., Br J Anaesth, 2011, 106, 6, 785-791, doi: 10.1093/bja/aer096.