Amiodarone prophylaxis for atrial fibrillation in patients undergoing surgery for lung cancer: A controlled, randomized, double blinded trial.

INTERVENTION: Trade Name: Cordarone Pharmaceutical Form: Tablet INN or Proposed INN: Amiodarone CAS Number: 19774824 Other descriptive name: Cordarone Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Cordarone Pharmaceutical Form: Intravenous infusion INN or Proposed INN: Amiodarone CAS Number: 19774824 Other descriptive name: Cordarone Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50‐ Pharmaceutical form of the placebo: Injection* Route of administration of the placebo: Intravenous bolus use (Noncurrent) CONDITION: Atrial fibrillation after lung resection due to cancer in the lung ; MedDRA version: 9.1 Level: LLT Classification code 10003658 Term: Atrial fibrillation ; MedDRA version: 9.1 Level: LLT Classification code 10025065 Term: Lung carcinoma cell type unspecified recurrent PRIMARY OUTCOME: Main Objective: To reduce the incidence of atrial fibrillation after lung resection due to lung cancer Primary end point(s): 1) Atrial fibrillation; 2) Symptomatic atrial fibrillation; 3) Length of stay Secondary Objective: To compile the cost‐effectiveness of the instituted prophylaxis INCLUSION CRITERIA: 1) Enlisted for lungresection due to pulmonary neoplasma 2) Elective surgery 3) Willingness of randomisation 4) Above 18 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range