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First clinical trial with iohexol in myelography
Acta Radiologica: Diagnosis
|January 1, 1983
Summary
This clinical trial found iohexol safe for lumbar myelography, with only minor side effects in 8 patients. No seizures or significant changes in cerebrospinal fluid parameters were observed.
Area of Science:
- Radiology
- Neurology
- Clinical Trials
Background:
- Lumbar myelography is a diagnostic procedure.
- Iohexol is a non-ionic contrast agent.
- Previous contrast agents have had associated adverse events.
Purpose of the Study:
- To evaluate the safety and tolerability of iohexol in lumbar myelography.
- To assess clinical and laboratory parameters following iohexol administration.
Main Methods:
- An open, non-comparative clinical trial involving 30 patients.
- Iohexol doses of 10-15 ml (180 mg I/ml) administered.
- Clinical assessments and laboratory tests performed pre-procedure and up to 48 hours post-procedure.
- Spinal re-puncture at 6 or 24 hours post-myelography.
Main Results:
- Only minor, temporary side effects reported in 8 patients.
- No seizures or electroencephalogram (EEG) abnormalities observed.
- No significant increase in cerebrospinal fluid (CSF) parameters including white blood cell count, protein, or IgG.
Conclusions:
- Iohexol is a safe and well-tolerated contrast agent for lumbar myelography.
- The study supports the use of iohexol in this clinical application.
- Further multicenter trials confirmed these findings.