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dc.contributor.authorRigby-Jones, AE
dc.contributor.authorSneyd, JR
dc.contributor.authorVijn, P
dc.contributor.authorBoen, P
dc.contributor.authorCross, M
dc.date.accessioned2012-11-09T22:03:51Z
dc.date.available2012-11-09T22:03:51Z
dc.date.issued2010-12
dc.identifier.issn1471-2253
dc.identifier.issn1471-2253
dc.identifier.other10
dc.identifier.urihttp://hdl.handle.net/10026.1/1219
dc.description.abstract

<jats:title>Abstract</jats:title><jats:sec><jats:title>Background</jats:title><jats:p>Org 25435 is a new water-soluble alpha-amino acid ester intravenous anaesthetic which proved satisfactory in animal studies. This study aimed to assess the safety, tolerability and efficacy of Org 25435 and to obtain preliminary pharmacodynamic and pharmacokinetic data.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>In the Short Infusion study 8 healthy male volunteers received a 1 minute infusion of 0.25, 0.5, 1.0, or 2.0 mg/kg (n = 2 per group); a further 10 received 3.0 mg/kg (n = 5) or 4.0 mg/kg (n = 5). Following preliminary pharmacokinetic modelling 7 subjects received a titrated 30 minute Target Controlled Infusion (TCI), total dose 5.8-20 mg/kg.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Within the Short Infusion study, all subjects were successfully anaesthetised at 3 and 4 mg/kg. Within the TCI study 5 subjects were anaesthetised and 2 showed signs of sedation. Org 25435 caused hypotension and tachycardia at doses over 2 mg/kg. Recovery from anaesthesia after a 30 min administration of Org 25435 was slow (13.7 min). Pharmacokinetic modelling suggests that the context sensitive half-time of Org 25435 is slightly shorter than that of propofol in infusions up to 20 minutes but progressively longer thereafter.</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>Org 25435 is an effective intravenous anaesthetic in man at doses of 3 and 4 mg/kg given over 1 minute. Longer infusions can maintain anaesthesia but recovery is slow. Hypotension and tachycardia during anaesthesia and slow recovery of consciousness after cessation of drug administration suggest this compound has no advantages over currently available intravenous anaesthetics.</jats:p></jats:sec>

dc.format.extent10-
dc.format.mediumElectronic
dc.languageen
dc.language.isoeng
dc.publisherSpringer Science and Business Media LLC
dc.subject3214 Pharmacology and Pharmaceutical Sciences
dc.subject32 Biomedical and Clinical Sciences
dc.subjectClinical Trials and Supportive Activities
dc.subjectClinical Research
dc.subject6 Evaluation of treatments and therapeutic interventions
dc.subject6.1 Pharmaceuticals
dc.titleFirst administration to man of Org 25435, an intravenous anaesthetic: A Phase 1 Clinical Trial
dc.typejournal-article
dc.typeArticle
plymouth.author-urlhttps://www.ncbi.nlm.nih.gov/pubmed/20587019
plymouth.issue1
plymouth.volume10
plymouth.publisher-urlhttp://dx.doi.org/10.1186/1471-2253-10-10
plymouth.publication-statusPublished
plymouth.journalBMC Anesthesiology
dc.identifier.doi10.1186/1471-2253-10-10
plymouth.organisational-group/Plymouth
plymouth.organisational-group/Plymouth/Faculty of Health
plymouth.organisational-group/Plymouth/Faculty of Health/Peninsula Medical School
plymouth.organisational-group/Plymouth/Research Groups
plymouth.organisational-group/Plymouth/Research Groups/Plymouth Institute of Health and Care Research (PIHR)
plymouth.organisational-group/Plymouth/Users by role
plymouth.organisational-group/Plymouth/Users by role/Academics
dc.publisher.placeEngland
dcterms.dateAccepted2010-06-29
dc.identifier.eissn1471-2253
dc.rights.embargoperiodNot known
rioxxterms.versionofrecord10.1186/1471-2253-10-10
rioxxterms.licenseref.urihttp://www.rioxx.net/licenses/all-rights-reserved
rioxxterms.licenseref.startdate2010-06-29
rioxxterms.typeJournal Article/Review


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