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B. -i. Wenzel-hora - One of the best experts on this subject based on the ideXlab platform.
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Peripheral and penile angiography with Iotrolan 280 versus non-ionic monomers: results of the European clinical phase II and III trials
European Radiology, 1995Co-Authors: J. K. Gmeinwieser, B. -i. Wenzel-horaAbstract:To evaluate diagnostic quality, safety and local tolerance in peripheral arteriography, isotrolan (280 mg iodine/ml) was compared to the non-ionic monimers iopamidol (300 mg iodine/ml), iohexol (300 mg iodine/ml) and iopromide (300 mg iodine/ml) in nine randomized, double-blind, the suitability of Iotrolan 280 was evaluated in an interindividual, non-randomized, single-blind study. Pelvic-leg arteriography was performed in 298 patients, selctive femoral arteriography in 201, intra-arterial digital subtraction angiography in 20. Despite the 7% lower iodine content of Iotrolan, its contrast density was rated as good as that of the non-ionic monomers. Due to the few motion artifact, caused by motor pain reactions, the overall diagnostic quality of Iotrolan was good. The slightly higher viscosity of Iotrolan did not impair injectability. General tolerance was excellent with Iotrolan and with non-ionic monomers (2.3% minor adverse events versus 4.6%). With respect to local tolerance, Iotrolan demonstrated clear advantages. The frequency of completely painless injections was 91% in non-selective femoral angiography and 70% in penile arteiorgraphy (62, 25 and 10%, respectively, with comparator agents). in intra-arterial DSA of the hand, the injectio of iotrlan 280 was tolerated with minimal or no pain in 100% of patients (58% with iohexol 300). Iotrolan proved to be highly suitable for peripheral arteriography and for arteriography of the penis. Its major advantage is excellent local tolerance in examinations in which even low-osmolar non-ionic monomers may cause significant pain and unpleasant sensations of heat. Better local tolerance results in an improvement of diagnostic quality due to fewer motion artifacts.
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Clinical safety assessment of Iotrolan 280 in European clinical studies
European Radiology, 1995Co-Authors: O. M. Silvay-mandeau, C. Meissner, B. -i. Wenzel-horaAbstract:Iotrolan (280 mg iodine/ml) a new non ionic, isotonic dimeric, contrast agent, was evaluated in multicenter clinical stidues conducted in Europe between March 1987 and September 1992. The studies compared the efficacy and safety of the agent with the non-ionic monomeric contrast agents available at the time. Iotrolan was given intravenously to patients undergoing urography, head and body computed tomography phlebography and digital subtraction angiography. The agent was also studied after intra-arterial injections in cerebral, visceral and peripheral angiographic procedures as well as digital subtraction angiography. Data from 32 prospective double blind, randomized, controlled clinical studies, were evaluated. A total of 1203 patients received either iopromide, iohexol or iopamidol (all in concentration of 300 mg iodine/ml), and a further 1207 patients received iortrolan. As there were no sognificant differences ( P = 0.0853) in adverse events between the comparative agents, their adverse event data were pooled for evaluation with data from patients receiving Iotrolan. Adverse experiences were recorded in two categories — local tolerance (heat and pain) and general tolerance (generalized heat and adverse clinical events). After intra-arterial injection Iotrolan had a significantly lower incidence of local heat sensation ( P = 0.0001) and a significantly lower incidence of local pain ( P = 0.0001) compared with comparator agents. Also, after intravenous injection Iotrolan had a significantly lower incidence of local heat ( P = 0.0038). In the overall evaluation of general tolerance for all indications, Iotrolan was shown to produce significantly less generalized heat ( P = 0.0012) and a lower incidence of adverse events ( P = 0.061) compared with the reference agents.
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Iotrolan in pediatric examinations
European Radiology, 1995Co-Authors: J. Tröger, B. -i. Wenzel-hora, K. DargeAbstract:Iotrolan, a new non-ionic, dimeric, iodinated contrast agent, was compared with iohexol, a non-ionic, monomeric contrast agent, for suitability in pediatric patients. Two studies were performed. The gastrointestinal medication was studied in 20 infants using Iotrolan 300 versus iohexol 300. Contrast quality with Iotrolan 300 appears to be superior to iohexol 300. The renal indication was studied in a large, multicenter, double-blind trial, 167 children received intravenous doses of either Iotrolan 280 or iohexol 300 for urography, and contrast quality and safety were assessed. Iotrolan 280 appears to give better contrast quality in all areas of the kidney and the ureters. On the results of our experience, we recommend Iotrolan 300 for gastrointestinal imaging in pediatries, where barium sulfate is contraindicated, and Iotrolan 280 in pediatric urography. We suggest that Iotrolan 280 may also be suitable for all intravascular administrations.
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Iotrolan in urography: efficacy and tolerance in comparison with iohexol and iopamidol
European Radiology, 1995Co-Authors: J. M. G. Adolph, H. Engelkamp, W. Herbig, P. E. Peters, B. -i. Wenzel-horaAbstract:Iotrolan was compared with iohexol and iopamidol for efficacy and general tolerance in excretory urography in three controlled, randomized, inte-individual, double-blind studies. Two hundred and eighty-four patients received fixed doses of 100 ml, 120 ml or 150 ml Iotrolan 280 or iohexol 300/iopamidol 300 by rapid or bolus injection. Contrast quality in films taken 3–40 min after injection was rated by experienced radiologists both on an overall basis and with regard to distinct anatomical regions (parenchyma, pelvicalyceal system, ureter, bladder). In all studies, contrast quality was assessed as better in the Iotrolan group. In two studies (dosages 100 and 120 ml), significant differences in contrast quality were found in lavour of Iotrolan ( P < 0.05), and in the third study (dosage 150 ml) there was a trend towards better contrast quality in the Iotrolan group ( P = 0.06). General tolerance of Iotrolan was good with only minor side effects (Iotrolan 6.3%, iohexol/iopamidol 9.9%), but the difference was not significant. No severe adverse reactions were observed with Iotrolan. In comparison with non-ionic monomers, Iotrolan shows very good efficacy and general tolerance for excretory urography.
Tomoaki Miyazawa - One of the best experts on this subject based on the ideXlab platform.
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safety and pharmacokinetics of Iotrolan in hysterosalpingography retention and irritability compared with lipiodol
Investigative Radiology, 1995Co-Authors: Yoshiaki Miyamoto, Tomoaki Miyazawa, Ryoko Uchimoto, Taichi Tsujimoto, Katsumi Iwai, Kozue Ishida, Haruyoshi AzumaAbstract:RATIONALE AND OBJECTIVES.The authors compared the safety and pharmacokinetics of Iotrolan (water-soluble) in hysterosalpingography (HSG) with those of Lipiodol (oil-soluble).METHODS.Iotrolan and Lipiodol were administered intraperitoneally at doses of 100 mg iodine/kg to female rabbits. Retention in
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preclinical evaluation of Iotrolan as a contrast medium for angiography and urography
Nihon Igaku Hōshasen Gakkai zasshi. Nippon acta radiologica, 1992Co-Authors: Tomoaki Miyazawa, Chie Murayama, Ryoko Uchimoto, Bernhard FritzzierothAbstract:: Efficacy and tolerability of Iotrolan, a nonionic isotonic dimer, as a contrast medium for angiography and urography were investigated in animals. In the arteriography of rabbit femur, the efficacy of Iotrolan 280 mgI/ml was as good as iopamidol 300 mgI/ml and better than meglumine diatrizoate 306 mgI/ml. In rat urography, the efficacy of Iotrolan 280 mgI/ml was better than both iopamidol 370 mgI/ml and iohexol 350 mgI/ml. Vascular pain was less with Iotrolan 280 mgI/ml than with iohexol 300 mgI/ml in rats. Effect of Iotrolan on the pulmo-cardiovascular parameters, arterial pO2, hematocrit and plasma osmolality was less than iopamidol and diatrizoate in rabbits. Iotrolan induced no renal dysfunction and diuresis where iopamidol induced diuresis in rats. Effect of Iotrolan on the blood coagulation was similar to nonionic monomers and less than diatrizoate in rabbits. Because of its isotonicity, Iotrolan induced little water shift in the blood vessel and urinary tract, which would result in good efficacy and tolerability. These results suggest that Iotrolan is superior to ionic and nonionic monomers for angiography and urography.
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effect of water soluble contrast medium on the lung in rats comparison of Iotrolan iopamidol and diatrizoate
Investigative Radiology, 1990Co-Authors: Tomoaki Miyazawa, Hidehiko Nakagawa, Nozomu OshinoAbstract:: Aspiration is a serious complication of oral contrast media (CM). The authors investigated the effects of Iotrolan, iopamidol, and diatrizoate in rats' lungs. To quantify the lung damage induced by CM, pulmonary water and hemoglobin contents were determined. Arterial blood-gas exchange (pH, PCO2, and PO2) also was determined as an indicator of respiratory function. Iotrolan, iopamidol, or sodium/meglumine diatrizoate with a concentration of 300 mg I/mL was administered intrabronchially at a dose of 1 mL/kg. Physiologic saline was administered to the control group. Ten minutes after administration, arterial blood was collected and the lung was removed. Diatrizoate and iopamidol increased pulmonary water and hemoglobin contents and decreased blood PO2. The effect of Iotrolan on these parameters was slight and no significant differences were observed between the Iotrolan and saline groups. These results suggest that Iotrolan is a preferable CM for gastrointestinal examination in the case of suspected aspiration.
Danielle De Greef - One of the best experts on this subject based on the ideXlab platform.
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Comparison in myelography between iodixanol 270 and 320 mgI/ml and Iotrolan 300 mgI/ml: a multicentre, randomised, parallel-group, double-blind, phase III trial
European Radiology, 2002Co-Authors: Yvan Palmers, Fritz-peter Kuhn, Dirk Petersen, Danielle De GreefAbstract:The objective of the trial was to compare the safety and efficacy of the non-ionic, dimeric, isotonic contrast medium iodixanol (Visipaque 270 and 320 mgI/ml) with those of Iotrolan (Isovist 300 mgI/ml) in myelography. After lumbar or cervical puncture, 315 patients were examined in a multicentre, double-blind, randomised, comparative myelography study. Image quality, changes in vital signs, immediate and delayed adverse events were registered. There was a tendency for better images with iodixanol 320 than with iodixanol 270 and Iotrolan 300, but the overall quality was good or excellent with all products. The frequency of patients reporting adverse events and headache varied much across centres, but there was no statistically significant difference between the contrast media. The incidence of events was higher after lumbar puncture than after cervical puncture, in women rather than in men, and after puncture with a 22-gauge (G) bevel-tipped needle compared with a 24 G Sprotte needle. The frequency of headache did not correlate with the absence of pathology. The higher iodine concentration in iodixanol 320 could be an advantage for film quality. When compared with Iotrolan 300, iodixanol 320 and 270 give similar incidences of adverse events, including headache.
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comparison in myelography between iodixanol 270 and 320 mgi ml and Iotrolan 300 mgi ml a multicentre randomised parallel group double blind phase iii trial
European Radiology, 2002Co-Authors: Yvan Palmers, Fritz-peter Kuhn, Dirk Petersen, Danielle De GreefAbstract:The objective of the trial was to compare the safety and efficacy of the non-ionic, dimeric, isotonic contrast medium iodixanol (Visipaque 270 and 320 mgI/ml) with those of Iotrolan (Isovist 300 mgI/ml) in myelography. After lumbar or cervical puncture, 315 patients were examined in a multicentre, double-blind, randomised, comparative myelography study. Image quality, changes in vital signs, immediate and delayed adverse events were registered. There was a tendency for better images with iodixanol 320 than with iodixanol 270 and Iotrolan 300, but the overall quality was good or excellent with all products. The frequency of patients reporting adverse events and headache varied much across centres, but there was no statistically significant difference between the contrast media. The incidence of events was higher after lumbar puncture than after cervical puncture, in women rather than in men, and after puncture with a 22-gauge (G) bevel-tipped needle compared with a 24 G Sprotte needle. The frequency of headache did not correlate with the absence of pathology. The higher iodine concentration in iodixanol 320 could be an advantage for film quality. When compared with Iotrolan 300, iodixanol 320 and 270 give similar incidences of adverse events, including headache.
Kazuo Hanaoka - One of the best experts on this subject based on the ideXlab platform.
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Case Reports/Case Series Encephalopathy and rhabdomyolysis induced by Iotrolan during epiduroscopy (Encéphalopathie et rhabdomyolyse provoquées par l'Iotrolan durant l'épiduroscopie)
2020Co-Authors: Ju Mizuno, Tobias Gauss, Masahiro Suzuki, Masakazu Hayashida, Hideko Arita, Kazuo HanaokaAbstract:Purpose: We describe a complication of epiduroscopy with encephalopathy and rhabdomyolysis associated with the contrast medium Iotrolan. Clinical features: A 76-yr-old man with failed back surgery syndrome underwent epiduroscopy. Sufficient lysis could not be achieved in the epidural space above the level of L 4 due to dense adhesions and scar tissue. After epidural injections of Iotrolan and mepivacaine, he developed motor weakness and hypoesthesia in both legs, which lasted for three hours. He also became confused, agitated, disoriented, and developed neck stiffness and tremors involving the head and legs. Computed tomography revealed diffuse contrast enhancement within the intracranial cerebrospinal fluid (CSF) spaces, indicating an intraoperative dural tear. Marked increases in serum creatinine phosphokinase and myoglobin indicated subsequent acute rhabdomyolysis. Crystalloid infusion and semi-recumbent positioning facilitated Iotrolan absorption from the CSF, and the patient recovered uneventfully. Conclusions: Dural tear during epiduroscopy may allow access of contrast media into the CSF. Neurotoxicity secondary to Iotrolan within the CSF was a likely contributing factor to the encephalopathy and subsequent rhabdomyolysis. This is an instructive example of the importance of diagnosing inadvertent dural tear during epiduroscopy under Iotrolan, for avoidance of adverse events such as encephalopathy and rhabdomyolysis.
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encephalopathy and rhabdomyolysis induced by Iotrolan during epiduroscopy
Canadian Journal of Anaesthesia-journal Canadien D Anesthesie, 2007Co-Authors: Ju Mizuno, Tobias Gauss, Masahiro Suzuki, Masakazu Hayashida, Hideko Arita, Kazuo HanaokaAbstract:PURPOSE: We describe a complication of epiduroscopy with encephalopathy and rhabdomyolysis associated with the contrast medium Iotrolan. CLINICAL FEATURES: A 76-yr-old man with failed back surgery syndrome underwent epiduroscopy. Sufficient lysis could not be achieved in the epidural space above the level of L4 due to dense adhesions and scar tissue. After epidural injections of Iotrolan and mepivacaine, he developed motor weakness and hypoesthesia in both legs, which lasted for three hours. He also became confused, agitated, disoriented, and developed neck stiffness and tremors involving the head and legs. Computed tomography revealed diffuse contrast enhancement within the intracranial cerebrospinal fluid (CSF) spaces, indicating an intraoperative dural tear. Marked increases in serum creatinine phosphokinase and myoglobin indicated subsequent acute rhabdomyolysis. Crystalloid infusion and semi-recumbent positioning facilitated Iotrolan absorption from the CSF, and the patient recovered uneventfully. CONCLUSIONS: Dural tear during epiduroscopy may allow access of contrast media into the CSF. Neurotoxicity secondary to Iotrolan within the CSF was a likely contributing factor to the encephalopathy and subsequent rhabdomyolysis. This is an instructive example of the importance of diagnosing inadvertent dural tear during epiduroscopy under Iotrolan, for avoidance of adverse events such as encephalopathy and rhabdomyolysis.
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case reports case series encephalopathy and rhabdomyolysis induced by Iotrolan during epiduroscopy encephalopathie et rhabdomyolyse provoquees par l Iotrolan durant l epiduroscopie
2007Co-Authors: Ju Mizuno, Tobias Gauss, Masahiro Suzuki, Masakazu Hayashida, Hideko Arita, Kazuo HanaokaAbstract:Purpose: We describe a complication of epiduroscopy with encephalopathy and rhabdomyolysis associated with the contrast medium Iotrolan. Clinical features: A 76-yr-old man with failed back surgery syndrome underwent epiduroscopy. Sufficient lysis could not be achieved in the epidural space above the level of L 4 due to dense adhesions and scar tissue. After epidural injections of Iotrolan and mepivacaine, he developed motor weakness and hypoesthesia in both legs, which lasted for three hours. He also became confused, agitated, disoriented, and developed neck stiffness and tremors involving the head and legs. Computed tomography revealed diffuse contrast enhancement within the intracranial cerebrospinal fluid (CSF) spaces, indicating an intraoperative dural tear. Marked increases in serum creatinine phosphokinase and myoglobin indicated subsequent acute rhabdomyolysis. Crystalloid infusion and semi-recumbent positioning facilitated Iotrolan absorption from the CSF, and the patient recovered uneventfully. Conclusions: Dural tear during epiduroscopy may allow access of contrast media into the CSF. Neurotoxicity secondary to Iotrolan within the CSF was a likely contributing factor to the encephalopathy and subsequent rhabdomyolysis. This is an instructive example of the importance of diagnosing inadvertent dural tear during epiduroscopy under Iotrolan, for avoidance of adverse events such as encephalopathy and rhabdomyolysis.
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Encephalopathy and rhabdomyolysis induced by Iotrolan during epiduroscopy
Canadian Journal of Anesthesia, 2007Co-Authors: Ju Mizuno, Tobias Gauss, Masahiro Suzuki, Masakazu Hayashida, Hideko Arita, Kazuo HanaokaAbstract:Objectif Nous décrivons une complication survenue lors d’une épiduroscopie avec le produit de contraste Iotrolan consistant en une encéphalopathie et une rhabdomyolyse. Eléments cliniques Un homme de 76 ans présentant des séquelles d’un échec d’une chirurgie aux rachis a subi une épiduroscopie. Une lyse suffisante n’a pas pu être obtenue dans l’espace péridural au-dessus de L_4 à cause d’adhésions denses et de tissus cicatriciels. Suite à des injections péridurales d’Iotrolan et de mépivacaïne, il a développé une parésie ainsi qu’une hypoesthésie au niveau des membres inférieurs qui durèrent trois heures. Il est également devenu confus, agité, désorienté, et a développé une raideur du cou et des tremblements de la tête et des jambes. La tomodensitométrie a révélé un rehaussement diffus du produit de contraste dans les espaces intracrâniens du liquide céphalo-rachidien (LCR), indiquant une déchirure péropératoire de la dure-mère. Des augmentations significatives de la créatinine-phosphokinase sérique et de la myoglobine signalant une rhabdomyolyse aiguë ultérieure ont été observées. Une perfusion de cristalloïde ainsi qu’un positionnement semi-allongé ont facilité l’absorption de l’Iotrolan du LCR, et le patient s’est rétabli sans problème. Conclusions La déchirure de la dure-mère durant l’épiduroscopie peuvent permettre l’injection de produit de contraste dans le LCR. Une neurotoxicité due à l’Iotrolan dans le LCR est un facteur qui a possiblement contribué à l’encéphalopathie et à la rhabdomyolyse subséquente. Ceci est un exemple instructif de l’importance du diagnostic de la déchirure de la dure-mère commises par inadvertence durant l’épiduroscopie sous Iotrolan, afin d’éviter des complications telles que l’encéphalopathie et la rhabdomyolyse. Purpose We describe a complication of epiduroscopy with encephalopathy and rhabdomyolysis associated with the contrast medium Iotrolan. Clinical features A 76-yr-old man with failed back surgery syndrome underwent epiduroscopy. Sufficient lysis could not be achieved in the epidural space above the level of L^4 due to dense adhesions and scar tissue. After epidural injections of Iotrolan and mepivacaine, he developed motor weakness and hypoesthesia in both legs, which lasted for three hours. He also became confused, agitated, disoriented, and developed neck stiffness and tremors involving the head and legs. Computed tomography revealed diffuse contrast enhancement within the intracranial cerebrospinal fluid (CSF) spaces, indicating an intraoperative dural tear. Marked increases in serum creatinine phosphokinase and myoglobin indicated subsequent acute rhabdomyolysis. Crystalloid infusion and semi-recumbent positioning facilitated Iotrolan absorption from the CSF, and the patient recovered uneventfully. Conclusions Dural tear during epiduroscopy may allow access of contrast media into the CSF. Neurotoxicity secondary to Iotrolan within the CSF was a likely contributing factor to the encephalopathy and subsequent rhabdomyolysis. This is an instructive example of the importance of diagnosing inadvertent dural tear during epiduroscopy under Iotrolan, for avoidance of adverse events such as encephalopathy and rhabdomyolysis.
C. Meissner - One of the best experts on this subject based on the ideXlab platform.
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Clinical safety assessment of Iotrolan 280 in European clinical studies
European Radiology, 1995Co-Authors: O. M. Silvay-mandeau, C. Meissner, B. -i. Wenzel-horaAbstract:Iotrolan (280 mg iodine/ml) a new non ionic, isotonic dimeric, contrast agent, was evaluated in multicenter clinical stidues conducted in Europe between March 1987 and September 1992. The studies compared the efficacy and safety of the agent with the non-ionic monomeric contrast agents available at the time. Iotrolan was given intravenously to patients undergoing urography, head and body computed tomography phlebography and digital subtraction angiography. The agent was also studied after intra-arterial injections in cerebral, visceral and peripheral angiographic procedures as well as digital subtraction angiography. Data from 32 prospective double blind, randomized, controlled clinical studies, were evaluated. A total of 1203 patients received either iopromide, iohexol or iopamidol (all in concentration of 300 mg iodine/ml), and a further 1207 patients received iortrolan. As there were no sognificant differences ( P = 0.0853) in adverse events between the comparative agents, their adverse event data were pooled for evaluation with data from patients receiving Iotrolan. Adverse experiences were recorded in two categories — local tolerance (heat and pain) and general tolerance (generalized heat and adverse clinical events). After intra-arterial injection Iotrolan had a significantly lower incidence of local heat sensation ( P = 0.0001) and a significantly lower incidence of local pain ( P = 0.0001) compared with comparator agents. Also, after intravenous injection Iotrolan had a significantly lower incidence of local heat ( P = 0.0038). In the overall evaluation of general tolerance for all indications, Iotrolan was shown to produce significantly less generalized heat ( P = 0.0012) and a lower incidence of adverse events ( P = 0.061) compared with the reference agents.
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Renal tolerance of Iotrolan 280 —a meta-analysis of 14 double-blind studies
European Radiology, 1995Co-Authors: W. Clauß, J. Dinger, C. MeissnerAbstract:Clinical data from 14 randomized double-blind studies were reviewed to compare the renatl tolerance of non-ionic monomeric contrast agents (iopamidol 300, iopromide 300, iohexol 300) with the non-ionic dimer Iotrolan 280. A prospective study of Iotrolan 280 versus iohexol 300 in renally impaired patients was also evaluated. Differences between the contrast agents were investigated using sub-group analysis of patients with an increased risk of contrast-induced nephropathy. Both the prospective study and meta-analysis of previous studies indicate that Iotrolan 280 has less influence on renal function than the non-ionic monomeric comparator agents.