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An Open-label Comparison of a New Generic Sevoflurane Formulation With Original Sevoflurane in Patients Scheduled for Elective Surgery Under General Anesthesia
DC Field | Value | Language |
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dc.contributor.author | 변효진 | - |
dc.date.accessioned | 2016-02-04T11:28:40Z | - |
dc.date.available | 2016-02-04T11:28:40Z | - |
dc.date.issued | 2015 | - |
dc.identifier.issn | 0149-2918 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/140511 | - |
dc.description.abstract | Purpose: To compare the stability, effectiveness, and safety profiles of a new generic sevoflurane with those of the original sevoflurane formulation in patients undergoing elective surgery. Methods : An accelerated 3-month storage test was performed to evaluate the compositional changes in generic sevoflurane stored in glass bottles. In addition, 182 patients were randomly allocated to receive generic (n = 89 [54 men and 35 women]; mean [SD] age, 49.9 [11.6] years) or original (n = 93 [61 men and 32 women]; mean [SD] age, 49.6 [11.1] years) sevoflurane at a gas flow of 3 L/min for approximately 3 hours. The mean minimum alveolar concentration (MAC) during sevoflurane anesthesia was evaluated, and gas samples for measuring compound A were collected from the inspiratory limb of the circuit at preset intervals. Blood samples for measuring serum inorganic fluoride were obtained at preset intervals (pharmacokinetic group: generic/original sevoflurane = 45/46). Renal biomarkers, such as N-acetyl-β-glucosaminidase, α- and π-glutathione-S-transferase, albumin, urine protein and osmolality, serum creatinine and osmolality, creatinine clearance, and blood urea nitrogen, were measured at preset intervals (renal biomarker group: generic/original sevoflurane = 44/47). Adverse reactions were monitored for 72 hours after discontinuation of sevoflurane use. Findings : Generic sevoflurane contained in glass bottles was stable for 3 months. The mean MAC was similar for generic and original sevoflurane (median [range], 0.93 [0.67–1.29] vs 0.94 [0.63−1.5] vol%). Adverse event rates were similar (90.3% vs 84.3%), as were the AUClast of inorganic fluoride (333.7 [112.7−1264.7] vs 311.9 [81.5−1266.5] hours·μmol/L) and compound A (51.8 [6.3−204.5] vs 55.3 [10.8−270.6] hours·ppm). Biomarkers associated with renal injury were not significantly different between the 2 formulations. | - |
dc.description.statementOfResponsibility | open | - |
dc.format.extent | 887~901 | - |
dc.relation.isPartOf | CLINICAL THERAPEUTICS | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/2.0/kr/ | - |
dc.subject.MESH | Adult | - |
dc.subject.MESH | Aged | - |
dc.subject.MESH | Anesthesia, General/methods* | - |
dc.subject.MESH | Anesthetics, Inhalation/administration & dosage* | - |
dc.subject.MESH | Anesthetics, Inhalation/adverse effects | - |
dc.subject.MESH | Blood Urea Nitrogen | - |
dc.subject.MESH | Elective Surgical Procedures/methods | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Kidney/metabolism | - |
dc.subject.MESH | Kidney Function Tests | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Methyl Ethers/administration & dosage* | - |
dc.subject.MESH | Methyl Ethers/adverse effects | - |
dc.subject.MESH | Middle Aged | - |
dc.subject.MESH | Young Adult | - |
dc.title | An Open-label Comparison of a New Generic Sevoflurane Formulation With Original Sevoflurane in Patients Scheduled for Elective Surgery Under General Anesthesia | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Anesthesiology (마취통증의학) | - |
dc.contributor.googleauthor | Hyo-Jin Byon | - |
dc.contributor.googleauthor | Byung-Moon Choi | - |
dc.contributor.googleauthor | Ji-Yeon Bang | - |
dc.contributor.googleauthor | Eun-Kyung Lee | - |
dc.contributor.googleauthor | Sang-Seok Lee | - |
dc.contributor.googleauthor | Gyu-Jeong Noh | - |
dc.identifier.doi | 10.1016/j.clinthera.2015.01.012 | - |
dc.admin.author | false | - |
dc.admin.mapping | false | - |
dc.contributor.localId | A01863 | - |
dc.relation.journalcode | J00614 | - |
dc.identifier.eissn | 1879-114X | - |
dc.identifier.pmid | 25697421 | - |
dc.identifier.url | http://www.sciencedirect.com/science/article/pii/S0149291815000557 | - |
dc.subject.keyword | compound A | - |
dc.subject.keyword | effectiveness | - |
dc.subject.keyword | generic sevoflurane | - |
dc.subject.keyword | inorganic fluoride | - |
dc.contributor.alternativeName | Byon, Hyo Jin | - |
dc.contributor.affiliatedAuthor | Byon, Hyo Jin | - |
dc.rights.accessRights | not free | - |
dc.citation.volume | 37 | - |
dc.citation.number | 4 | - |
dc.citation.startPage | 887 | - |
dc.citation.endPage | 901 | - |
dc.identifier.bibliographicCitation | CLINICAL THERAPEUTICS, Vol.37(4) : 887-901, 2015 | - |
dc.identifier.rimsid | 30140 | - |
dc.type.rims | ART | - |
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