Condition category
Circulatory System
Date applied
11/06/2008
Date assigned
18/07/2008
Last edited
22/08/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Roger Stedman

ORCID ID

Contact details

2nd Floor
Lincoln House
Heartlands Hospital
Bordesley Green East
Birmingham
B5 5SS
United Kingdom

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 measures

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

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

http://www.heartofengland.nhs.uk

Funders

Funder type

Charity

Funder name

British Heart Foundation (UK)

Alternative name(s)

BHF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

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

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21558066

Publication citations

  1. 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.

Additional files

Editorial Notes