Cancer: Lung Cancer Lung
Conditions
Interventions
Patients will be randomly allocated in equal numbers to treatment with or without magnesium sulphate and followed-up during the in-hospital perioperative period.
Sponsors
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Eligibility
Inclusion criteria
Inclusion criteria: 240 subjects will be recruited. The investigator will be responsible for screening all patients listed for lung surgery at the CTC. Evidence from Terzi et al [32], had demonstrated that incidences of AF occurred in 10.7% of patients on magnesium sulphate as compared with 26.7% of control patients. We predict that at 90% power (2-sided ¿=0.05), 240 patients allowing for drop outs, deaths etc) are required to detect at least a 16% reduction in incidences of AF. Inclusion Criteria: 1. Elective for non-cardiac thoracic operations for lung cancer (lobectomy and pneumonectomy) 2. Ability to provide informed consent
Exclusion criteria
Exclusion criteria: 1. Patients not undergoing major lung resection (see above) 2. Impaired renal function, preoperative creatinine >200 mol/L 3. Myocardial infarction within the last 6 months 4. Urgent or emergency operations 5. Video assisted thoracic surgery 6. Currently on drugs with antiarrhythmic properties 7. Patients with a history of preoperative cardiac arrhythmias
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Atrial fibrillation will be assessed using a standard 12-lead ECG measurement from the onset of the Q wave to the end of the S wave. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Myocardial Infarction will be defined by two of the following three criteria if present: Unequivocal ECG changes. Elevation of cardiac enzyme(s): 3 times upper limit of creatinine kinase CK/CKMB) and above twice the upper limit of normal or elevated troponin (T/I). Chest pain typical of ischaemia lasting for more than 20 minutes. 2. Respiratory complications as determined by the requirement for postoperative mechanical ventilation greater than 24 hours or reintubation for ventilatory support after the day of surgery; pneumonia - defined as fever eukocytosis, pulmonary infiltrate requiring antibiotic therapy; air leak from thoracostomy tubes for more than six days postoperatively; lobar collapse on postoperative chest radiograph; empyema and bronchopleural fistula. Sputum retention defined as failure to clear bronchial secretions that can result in: bronchial obstruction, atelectasis, lobar collapse, secondary pulmonary infection. 3. Renal Complications - postoperative rise in serum creatinine above 200µmol/litre or requirement of postoperative dialysis support in a patient with normal preoperative renal function was considered to be a renal complication. 4. Neurological complications - a postoperative new cerebrovascular accident or transient ischaemic attack was considered to be a neurological complication. 5. Pulmonary embolus defined as a blockage of an artery in the lungs by fat, air, tumor tissue, or blood clot. 6. Death is defined as all-cause mortality and the cause of death will have to be specified. In the analysis, all deaths during the study period will be compared between the two groups. | — |
Countries
United Kingdom
Outcome results
None listed