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Lumbar myelography with iohexol and metrizamide: a comparative multicenter prospective study.

Diagnostic quality of radiographs and adverse reactions associated with the use of metrizamide and iohexol as contrast agents in lumbar myelography were compared in a prospective randomized double blind study in 350 patients at seven centers. The contrast media were administered in comparable volumes at a concentration of 180 mg I per ml. Overall quality of radiographic visualization was graded good or excellent in 95% of 175 metrizamide studies and in 98% of 175 iohexol studies. Ninety-three patients examined using metrizamide (53%) and 130 patients examined using iohexol (74%) experienced no discomfort during or after myelography. Postmyelographic headache was associated with 38% of metrizamide examinations and 21% of iohexol examinations. Nausea and vomiting were also more common with metrizamide. Five patients examined using metrizamide (3%) experienced transient confusion and disorientation following lumbar myelography. No such reactions were observed following iohexol myelography.

Adolescent↗

Lumbar myelography with iohexol in outpatients: prospective multicenter evaluation of safety.

A multicenter open, noncomparative evaluation of the safety of iohexol was prospectively conducted in 81 adult outpatients undergoing screen-film lumbar myelography. Iohexol (180 milligrams of iodine per milliliter) was administered via a lumbar route at a dose of 8-17 mL. Computed tomography (CT) was performed after myelography. The safety of iohexol was assessed by monitoring adverse reactions and neurologic status and by measuring vital signs and serum laboratory values. The most frequent adverse reaction was headache (16 of 81 patients [19.7%]). Twelve patients complained of a headache on the day of the myelographic procedure, and four patients reported a headache 24 hours after the procedure. Nausea or vomiting occurred in four of 81 patients (4.9%) only on the day myelography was performed. No other neurologic abnormalities were found. Iohexol produced myelographic and CT studies of good to excellent quality in all patients. This study indicates that iohexol can be employed safely in lumbar myelography of adult outpatients.

Adult↗

Evaluation of the vascular clinical trial program of metrizamide and iohexol.

The vascular clinical trial programs of the contrast media metrizamide (Amipaque) and iohexol ( Omnipaque ), organized by Nyegaard & Co. AS in Northern Europe were assessed and compared. The comparison comprised some selected characteristics of the programs, self-assessment by the investigators involved in both programs (questionnaire) and assessment of the standard of the trial reports (2 evaluators). It was found that Nyegaard clinical research staff spent in average 4 1/2 month for one iohexol trial compared with one month for one of metrizamide. The reason for this found to be a higher priority, increased regulatory requirements and a uniform data pool established for the iohexol program. In general, a quality improvement was revealed for the iohexol program over the metrizamide program. The 2 evaluators as well as the questioned investigators found the reporting standard of the iohexol trials significantly higher (p less than or equal to p less than or equal to 0.05) than that of the metrizamide trials.

Angiography↗

Measuring the size of the extracellular fluid space using bromide, iohexol, and sodium dilution.

There is a need to find methods to assess the size of the extracellular fluid (ECF) volume without involving radioactive tracers. For this purpose, we applied 3 methods for measuring the ECF volume in 10 male volunteers (mean age, 34 yr). Steady-state plasma bromide concentration (control) was compared to the results of kinetic analysis of plasma iohexol and to kinetic analysis of the dilution of serum sodium after IV infusion of 1 L of isotonic mannitol. The volume of distribution of these tracers was used to indicate the ECF volume. The results disclosed statistically significant correlations between the results of all 3 methods, although the average sodium dilution showed 0.7 L lower values than iohexol and 1.4 L lower than bromide. All three methods correlated significantly with body weight. The percentage of the body weight indicated by the methods was 18.3% (3.1%) for sodium, 19.6% (1.0%) for iohexol, and 20.5% (1.1%) for bromide. We conclude that sodium dilution may be performed at bedside but iohexol and bromide showed less intersubject variability. Iohexol simultaneously measures the glomerular filtration rate and should be a viable clinical option if the hospital performs routine assessments of kidney function using this tracer.

Adult↗

Iodixanol in paediatric gastrointestinal imaging: safety and efficacy comparison with iohexol.

Iodixanol (Visipaque) is a dimeric, non-ionic iodinated contrast medium that is isotonic with blood at all clinically relevant concentrations. Iodixanol was compared in a randomized, double blind, parallel group, phase III multicentre trial with a monomeric, non-ionic contrast medium, iohexol (Omnipaque), at two concentrations assessing safety, tolerability and radiographic efficacy during contrast enhanced gastrointestinal radiography examinations of children. 154 children entered the trial; 152 formed the safety population and 147 the efficacy population. All examinations were performed following standard departmental practice. Children were assigned into either a high or low concentration group (iodixanol, 150 mgI ml(-1) and 320 mgI ml(-1) vs iohexol, 140 mgI ml(-1) and 300 mgI ml(-1)). The primary outcome measure for efficacy was the overall quality of visualization, which was assessed using a 100 mm visual analogue scale (VAS). The secondary efficacy variables assessed were quality of contrast opacification, mucosal coating and overall quality of diagnostic information. Safety evaluation involved patient follow-up for at least 48 h. Taste acceptance was also assessed. There was no statistically significant difference between the two contrast media with regard to the primary and secondary efficacy variables assessed, although higher ratings were observed for iodixanol. The 100 mm VAS score overall was 86 mm for iodixanol and 82 mm for iohexol (95% confidence interval -2.56, 10.42). The frequency of adverse events was lower for patients receiving iodixanol. Adverse events, mainly diarrhoea, occurred in 12 patients (16.2%) in the iodixanol group and 28 patients (35.9%) in the iohexol group. This reached statistical significance (p=0.006). Overall, iodixanol is well suited for examinations of the gastrointestinal tract, giving good efficacy results and fewer adverse events than iohexol.

Adolescent↗

Anticoagulant effects of contrast materials: in vitro study of iohexol, ioxaglate, and diatrizoate.

It has been reported that clot formation may occur when blood is mixed directly with nonionic contrast medium in a syringe during angiography. To investigate this possibility, we performed three in vitro experiments to determine the anticoagulant properties of a low-osmolar, nonionic contrast medium (iohexol); a low-osmolar, ionic medium (ioxaglate); and a high-osmolar, ionic medium (diatrizoate). In the first experiment, human arterial blood was incubated at room temperature in an angiographic syringe with each of the three media for 60 min, after which the mixture was filtered for clots. In the second experiment, the clotting times of venous blood in heparinized saline or serial dilutions of the three agents were determined. In the third experiment, the partial thromboplastin time of platelet-poor plasma in heparinized saline or serial dilutions of the three agents was measured. No clots were observed in any of the arterial blood samples. Iohexol prolonged the normal 15-min clotting time of venous blood to 160 min, compared with a clotting time of at least 330 min for ioxaglate and diatrizoate. Iohexol prolonged the normal 36-sec partial thromboplastin time of platelet-poor plasma to 40 sec, compared with 50 sec for diatrizoate and 54 sec for ioxaglate. Our data show that iohexol, like ioxaglate and diatrizoate, inhibits clot formation when mixed with blood in a syringe. It prolongs the clotting time to approximately the same degree as 600 U/l of heparinized saline, but to a lesser degree than the other two media. All three media have a minimal effect on the partial thromboplastin time. Our results do not show any risk of clot formation in the usual clinical setting in which there is inadvertent mixing of blood with iohexol, ioxaglate, or diatrizoate in an angiographic syringe.

Angiography↗

Effects in vivo of iohexol and diatrizoate on human plasma acetyl- and butyryl-cholinesterase activity.

PURPOSE: The aim of this study was to evaluate the effects of two iodinate contrast agents (CA), iohexol and diatrizoate, on human plasma acetyl-(AC) and butyrylcholinesterase(BC) activity. MATERIAL AND METHODS: Forty-eight patients (24 males and 24 females) scheduled for intravenous pyelography were randomly divided into four groups of 6 males and 6 females each, receiving as CA, respectively: iohexol (Omnipaque, Schering) 0.6 ml/kg body weight (G1); iohexol 1.2 mg/kg (G2); sodium and meglumine diatrizoate 58% (Urografin, Schering) 0.6 ml/kg (G3); sodium and meglumine diatrizoate 58% 1.2 ml/kg (G4). Blood samples were taken before and 5, 10, and 20 min after the injection. Enzymatic activity of AC and BC were measured by spectrophotometry. Plasma concentration of K, Na, Ca, and Mg was measured in all blood samples; blood pressure and plasma pH were measured after each sample collection. Statistical analysis was performed by Student's test. RESULTS: In G1 a reversible decrease of AC (12.9%) and BC (8.2%) plasma activity was observed at 10 min. In G2 a progressive decrease of AC (13.9%) and BC (18.4%) plasma activity was observed with a maximum at 20 min. In G3 a modest reversible decrease of BC plasma activity (5.4%) was observed. In G4 a modest progressive decrease of AC (7.3%) and BC (6.5%) plasma activities was observed. In all cases, AC and BC plasma activities remained within the normal range of values. Plasma concentration of K, Na, Ca, and Mg, as well as pH and systolic and diastolic pressure, did not show any change. No adverse effects was observed in our patients. CONCLUSIONS: Iohexol and diatrizoate induce in vivo a significant decrease of AC and BC plasma activities. The decrease is more pronounced for iohexol, a non ionic CA, which has a lower pharmacotoxicity than diatrizoate and adverse effects rate. No inference can be drawn about the relationship between plasma cholinesterase activity and adverse effects.

Butyrylcholinesterase↗

A double-blind comparative study on the contrast quality, tolerance and safety of ioversol 300 versus iohexol 300 in central venous angiography (C.V. DSA).

A prospective, randomised, double-blind study was performed to test the contrast quality, tolerance and safety of ioversol 300 mg/ml (Optiray 300, Mallinckrodt Medical, Inc., St-Louis, USA) versus iohexol 300 mg/ml (Omnipaque 300, Schering AG, Berlin). The study was conducted on 80 patients with peripheral vascular disease, who underwent central venous pelvis-leg angiography. The angiograms in the ioversol group were rated "very good" and "good" in 75.6% of the cases versus 51.3% in the iohexol group. Patient tolerance was nearly identical in both groups. On the 4 point rating scale for pain and heat sensations (1 = none; 4 = severe), the average heat scores were 1.28 for ioversol and 1.44 for iohexol. None of the patients complained of pain when receiving the injection. There were clinically significant changes of blood pressure in 3 patients out of each group and tachycardia in 5 patients in the ioversol group and 9 patients in the iohexol group. Seven out of 80 patients reported mild to moderate side-effects. These were related to the contrast medium in the case of 2 patients in both the ioversol and the iohexol group. All reactions resolved spontaneously or could be controlled by treatment.

Adult↗

Addition of sodium to the nonionic contrast medium iohexol during coronary angiography in man. Lack of electrocardiographic or hemodynamic effects.

It has recently been claimed that lack of sodium in nonionic contrast media may increase the risk of ventricular arrhythmias during coronary angiography. Thus, the influence of sodium addition to the nonionic contrast medium iohexol was studied in 75 patients with severe coronary heart disease. The study design was randomized, parallel and double-blind, and iohexol was given either with or without addition of NaCl (28 mmol/l). Both formulations induced a transient drop in arterial blood pressure, and prolongation of the QT interval and QRS duration at 10 s only (p less than 0.01). The electrical QRS axis was significantly changed by the coronary artery injections after 10 s, but not later. No differences between iohexol with and without NaCl were observed for any of the variables studied. No serious arrhythmias were observed. Thus, the addition of NaCl (28 mmol/l) to iohexol did not influence the electrocardiographic or hemodynamic changes induced by iohexol during coronary angiography.

Aged↗

[Speech disturbance following myelography with iohexol: a case report].

Iohexol (Omnipaque) is a non-ionic contrast media for neuroradiology, which causes the neurological complications on rare occasions. A 63-year-old, righthanded female suffered from dysphemia 12 hours after myelography with iohexol via lumbar puncture. The initial cerebral computed tomography scan revealed the generalized contrast media uptake into the cisterns, which was typical to the finding after intrathecal iohexol injection. Although the cerebral magnetic resonance (MR) imaging 7 days after attack also demonstrated no abnormal finding, the electrical encephalogram revealed the sporadic sharp wave activity. Her nonfluent speech deficit had recovered gradually, however, the neurogenic stuttering was still remained. Some literatures previously reported the cases with speech deficits as complications of metrizamide myelography, whereas, a case manifesting as speech disturbance following myelography with iohexol has been not reported. Metrizamide is also a non-ionic agent and had a lower incidence of speech disturbance, which is supposed to be associated with a focal superficial neurotoxic reaction of the cerebrum. Therefore, our unfortunate case suggests that iohexol could rarely cause speech disturbance such as metrizamide.

Brain↗

Renal effects of iopentol and iohexol after intravenous injection.

Renal effects of the 2 non-ionic contrast media iopentol and iohexol were investigated and compared in a double-blind, randomized parallel study where 30 patients received iopentol, and 31 patients iohexol intravenously for abdominal CT. The dosage of contrast medium (350 mg I/ml) was 700 mg I/kg body weight. Only one patient (in the iohexol group) had an increase in serum creatinine of more than 50%. Iopentol and iohexol had no effects on the mean serum values of creatinine, urea, and beta 2-microglobulin (beta 2-MG) nor on creatinine clearance. The urinary excretion of albumin and beta 2-MG was also unchanged. The excretion of the proximal tubular enzymes alkaline phosphatase and N-acetyl-beta-glucosaminidase was increased. No significant difference between iopentol and iohexol was found.

Acetylglucosamine↗

A comparison of blood-brain barrier disruption by intracarotid iohexol and iodixanol in the rabbit.

A rabbit model was used to compare the effect on the blood-brain barrier of the intracarotid injection of two new contrast media: iohexol, a nonionic monomer, and iodixanol, a nonionic dimer. It was hypothesized that the low osmolality of iodixanol (272 mOsm/kg at 300 mgl/ml) would cause less disruption of the blood-brain barrier than the relatively higher osmolality of iohexol (690 mOsm/kg at 300 mgl/ml). The degree of blood-brain barrier disruption was assessed qualitatively, by observing the degree of cortical staining with Evans' Blue dye, and quantitatively, by calculating the difference in uptake of 99mTc-pertechnetate between injected and noninjected hemispheres. Statistical analysis of the results showed that both iodixanol and iohexol had a significantly greater effect on blood-brain barrier disruption than did isotonic saline (0.005 greater than p greater than .001), but that the effect of iodixanol was not significantly different from that of iohexol with respect to either Evans' Blue staining (p greater than .05) or pertechnetate uptake (.75 less than p less than .90). Thus, the low-osmolality iodixanol has no significant advantage over iohexol in terms of blood-brain barrier disruption after experimental carotid angiography.

Animals↗

Comparison of metrizamide and iohexol for cisternal myelographic examination of dogs.

A double-blind study, using metrizamide, iohexol, or Ringer's solution (control) as cisternal myelographic agents, was performed on 25 dogs. Before myelographic examination was done, each dog was subjected to physical, clinical pathologic, and neurologic examinations, as well as examinations by electroencephalography and computerized tomography. These were repeated 24 hours after completion of the myelographic examination. The group of dogs given metrizamide (group II) had a significantly greater occurrence of seizure activity (6 of 10) than did the control dogs (group I; 0 of 5) or dogs given iohexol (group III; 0 of 10; P less than 0.003). In group II, the CSF microprotein concentration was significantly greater 24 hours after myelography was done than were the values in groups I and III (P less than 0.003). Myelograms of the group II dogs (metrizamide) and group III dogs (iohexol) had similar diagnostic qualities. At 24 hours after myelographic examination was done, computerized tomography scan revealed that each dog given metrizamide and iohexol had myelographic contrast material in the brain and cervical spinal cord parenchyma. Seemingly, iohexol has good diagnostic quality, but is less epileptogenic than metrizamide when used in cervical myelographic examinations of dogs.

Animals↗

Iohexol: a new, nonionic agent in adult peripheral arteriography.

The safety and efficacy of iohexol, a new nonionic contrast agent, were compared with a diatrizoate (Renografin-76) in a double-blind, parallel study of peripheral arteriography by femoral puncture in 60 patients. Extra-large field serial peripheral arteriography was used and a posterior tibial nerve block was applied to all patients in the study. Similar changes in blood chemistry were observed following the injection of iohexol and diatrizoate but these changes did not require corrective measures. Significantly more patients complained of a sensation of severe heat after receiving diatrizoate (38%) than after the injection of iohexol (10%) (p = 0.001). Four patients in the diatrizoate group experienced one or more adverse reactions, including mild urticaria. Only mild nausea was reported by a single patient in the iohexol group. Overall, 100% of the studies were diagnostic but more of the radiographs taken after the injection of iohexol were rated excellent than after the injection of diatrizoate.

Adult↗

Non-ionic contrast media in cardioangiography in infants. A comparison of iohexol and metrizamide.

Iohexol (300 mg I/ml) was compared with metrizamide (300 mg I/ml) in pediatric cardioangiography. Forty consecutive patients below one year of age were included in an open, randomized, comparative two-group investigation. Immediate extrasystoles occurred frequently at injections of contrast medium, but the frequency did not differ significantly between metrizamide and iohexol. Both contrast media caused only minor changes in heart rate. Iohexol caused a significantly larger increase in end diastolic pressure following injections in the left ventricle than did metrizamide. The pressure changes registered were, however, moderate in both contrast media groups and the difference between the two contrast media is probably of no clinical importance. A moderate plasma volume expansion was noted after injection of both contrast media. Metrizamide caused a slight increase of ASAT in the 10 min blood sample which differed significantly from that of iohexol, but no increase of enzyme activity was noted after 24 h and the change was considered to be of no clinical importance. Image quality was similar with both contrast media. Iohexol and metrizamide were well tolerated in pediatric cardioangiography.

Angiocardiography↗

Iohexol in coronary angiography. A comparison of ionic and non-ionic contrast media.

Iohexol (350 mg I/ml) has been compared with meglumine-Na-Ca metrizoate (370 mg I/ml) in selective coronary angiography in 37 adult patients. Iohexol was very well tolerated and resulted in only minor changes in blood pressure and ECG parameters. Changes in blood pressure and R-R interval were significantly more marked following injections of metrizoate than after injections of iohexol. Arrhythmias were not observed following injections of iohexol, while two patients had AV block II after injection of metrizoate. Both contrast media gave similar and adequate demonstration of the coronary vessels. The findings suggest that iohexol has distinct advantages over metrizoate in selective coronary angiography.

Adult↗

Urography with iohexol. Comparison with metrizoate and iodamide.

Comparisons of the non-ionic medium iohexol with the ionic media Na-Ca-Mg metrizoate and meglumine iodamide, were performed in two separate trials. The difference in diagnostic properties between the media was not significant. There was a significantly lower frequency of subjective sensations after iohexol than after metrizoate, whereas the difference between iohexol and iodamide in this respect was small. Regarding other adverse reactions there was a small advantage in favour of iohexol compared with metrizoate, whereas iohexol caused significantly less adverse reactions than iodamide.

Adolescent↗

Cardioangiography in man using iohexol and meglumine-Na diatrizoate. A comparison of hemodynamic and electrocardiographic effects.

The initial clinical experience from 5 centers in the United States with iohexol for routine cardioangiography is presented. The investigation includes 124 patients who received iohexol and 127 patients who received meglumine-Na diatrizoate. Iohexol produced a lesser degree of systemic hypotension after coronary angiography and left ventriculography than diatrizoate. No deleterious electrocardiographic changes were observed after iohexol injections. Iohexol was well tolerated by the patients and it may become a preferred contrast medium for routine clinical cardioangiography.

Adult↗