A double-blind study comparing safety, tolerability and efficacy of iodixanol 320 mgI/ml and ioxaglate 320 mgI/ml in cerebral arteriography.

Iodixanol is a new nonionic dimer, isotonic with blood at all concentrations. Iodixanol 320 mgI/ml was compared in a double-blind, randomized study to the ionic dimer ioxaglate 320 mgI/ml for evaluation of safety and efficacy parameters during cerebral arteriography. Eighty adult patients were enrolled and all completed the trial. Radiographic efficacy was assessed from the diagnostic information and the radiographic density. Safety was evaluated by recording discomfort and other adverse events, changes in ECG, heart rate and blood pressure, changes in intra-arterial blood pressure and circulation time. No difference between the two contrast media were noted radiographically. No clinically important changes from baseline or between the two contrast media were found in ECG, heart rate, blood pressure or intra-arterial blood pressure. Although not statistically significant, a somewhat longer mean circulation time was found with iodixanol, probably due to its slightly higher viscosity. Injection-associated warmth sensation and pain were more intense with ioxaglate than with iodixanol, and pain was statistically more frequent after injection of ioxaglate. A high incidence of adverse events other than discomfort is reported in this study, mainly related to the selective arteriographic procedure itself. The adverse events related to the contrast medium were more frequent with ioxaglate (27% of the total number of adverse events) than with iodixanol (10%). The new isotonic nonionic dimer iodixanol offers significantly better comfort to the patient than does ioxaglate. This is an important feature, especially in relatively risky procedures that are unpleasant for the patients, such as conventional cerebral angiography.

RCT Entities:   Population Interventions Outcomes