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Article: A double-blind, crossover assessment of the sedative and analgesic effects of intranasal dexmedetomidine

TitleA double-blind, crossover assessment of the sedative and analgesic effects of intranasal dexmedetomidine
Authors
Issue Date2007
PublisherLippincott, Williams & Wilkins. The Journal's web site is located at http://www.anesthesia-analgesia.org
Citation
Anesthesia And Analgesia, 2007, v. 105 n. 2, p. 374-380 How to Cite?
AbstractBACKGROUND: The alpha2-receptor agonist, dexmedetomidine, provides sedation with facilitated arousal and analgesia with no respiratory depression. These properties render it potentially useful for anesthesia premedication, although parenteral administration is not practical in this setting. We designed this study to evaluate the sedative, anxiolytic, analgesic, and hemodynamic effects of dexmedetomidine administered intranasally in healthy volunteers. METHODS: Koch's design for crossover trials (three-treatment and two-period design) was adopted. The study was double-blind and there were three treatment groups: A (placebo), B (intranasal dexmedetomidine 1 μg/kg) and C (intranasal dexmedetomidine 1.5 μg/kg). Each of the 18 subjects participated in two study periods. The study drug was administered intranasally after baseline observations of modified Observer Assessment of Alertness/Sedation Scale, visual analog scale of sedation, bispectral index, visual analog scale of anxiety, pain pressure threshold measured by an electronic algometer, systolic blood pressure (SBP) and diastolic blood pressure, heart rate, respiratory rate, and oxygen saturation. These were repeated during the course of the study. RESULTS: Intranasal dexmedetomidine was well tolerated. Both 1 and 1.5 μg/kg doses equally produced significant sedation and decreases in bispectral index, SBP, diastolic blood pressure, and heart rate when compared with placebo (P < 0.05). The onset of sedation occurred at 45 min with a peak effect at 90-150 min. The maximum reduction in SBP was 6%, 23%, and 21% for Groups A, B, and C respectively. There was no effect on pain pressure threshold, oxygen saturation or respiratory rate. Anxiolysis could not be evaluated as no subjects were anxious at baseline. CONCLUSION: The intranasal route is effective, well tolerated, and convenient for the administration of dexmedetomidine. Future studies are required to evaluate the possible role of the noninvasive route of administration of dexmedetomidine in various clinical settings, including its role as premedication prior to induction of anesthesia. © 2007 by International Anesthesia Research Society.
Persistent Identifierhttp://hdl.handle.net/10722/147246
ISSN
2015 Impact Factor: 3.827
2015 SCImago Journal Rankings: 1.523
ISI Accession Number ID
References

 

DC FieldValueLanguage
dc.contributor.authorYuen, VMen_US
dc.contributor.authorIrwin, MGen_US
dc.contributor.authorHui, TWen_US
dc.contributor.authorYuen, MKen_US
dc.contributor.authorLee, LHYen_US
dc.date.accessioned2012-05-29T06:01:01Z-
dc.date.available2012-05-29T06:01:01Z-
dc.date.issued2007en_US
dc.identifier.citationAnesthesia And Analgesia, 2007, v. 105 n. 2, p. 374-380en_US
dc.identifier.issn0003-2999en_US
dc.identifier.urihttp://hdl.handle.net/10722/147246-
dc.description.abstractBACKGROUND: The alpha2-receptor agonist, dexmedetomidine, provides sedation with facilitated arousal and analgesia with no respiratory depression. These properties render it potentially useful for anesthesia premedication, although parenteral administration is not practical in this setting. We designed this study to evaluate the sedative, anxiolytic, analgesic, and hemodynamic effects of dexmedetomidine administered intranasally in healthy volunteers. METHODS: Koch's design for crossover trials (three-treatment and two-period design) was adopted. The study was double-blind and there were three treatment groups: A (placebo), B (intranasal dexmedetomidine 1 μg/kg) and C (intranasal dexmedetomidine 1.5 μg/kg). Each of the 18 subjects participated in two study periods. The study drug was administered intranasally after baseline observations of modified Observer Assessment of Alertness/Sedation Scale, visual analog scale of sedation, bispectral index, visual analog scale of anxiety, pain pressure threshold measured by an electronic algometer, systolic blood pressure (SBP) and diastolic blood pressure, heart rate, respiratory rate, and oxygen saturation. These were repeated during the course of the study. RESULTS: Intranasal dexmedetomidine was well tolerated. Both 1 and 1.5 μg/kg doses equally produced significant sedation and decreases in bispectral index, SBP, diastolic blood pressure, and heart rate when compared with placebo (P < 0.05). The onset of sedation occurred at 45 min with a peak effect at 90-150 min. The maximum reduction in SBP was 6%, 23%, and 21% for Groups A, B, and C respectively. There was no effect on pain pressure threshold, oxygen saturation or respiratory rate. Anxiolysis could not be evaluated as no subjects were anxious at baseline. CONCLUSION: The intranasal route is effective, well tolerated, and convenient for the administration of dexmedetomidine. Future studies are required to evaluate the possible role of the noninvasive route of administration of dexmedetomidine in various clinical settings, including its role as premedication prior to induction of anesthesia. © 2007 by International Anesthesia Research Society.en_US
dc.languageengen_US
dc.publisherLippincott, Williams & Wilkins. The Journal's web site is located at http://www.anesthesia-analgesia.orgen_US
dc.relation.ispartofAnesthesia and Analgesiaen_US
dc.subject.meshAdministration, Intranasalen_US
dc.subject.meshAdulten_US
dc.subject.meshAnalgesics, Non-Narcotic - Administration & Dosageen_US
dc.subject.meshAttention - Drug Effects - Physiologyen_US
dc.subject.meshBlood Pressure - Drug Effects - Physiologyen_US
dc.subject.meshCross-Over Studiesen_US
dc.subject.meshDexmedetomidine - Administration & Dosageen_US
dc.subject.meshDouble-Blind Methoden_US
dc.subject.meshFemaleen_US
dc.subject.meshHumansen_US
dc.subject.meshHypnotics And Sedatives - Administration & Dosageen_US
dc.subject.meshMaleen_US
dc.subject.meshPain Measurement - Drug Effectsen_US
dc.titleA double-blind, crossover assessment of the sedative and analgesic effects of intranasal dexmedetomidineen_US
dc.typeArticleen_US
dc.identifier.emailIrwin, MG:mgirwin@hku.hken_US
dc.identifier.authorityIrwin, MG=rp00390en_US
dc.description.naturelink_to_subscribed_fulltexten_US
dc.identifier.doi10.1213/01.ane.0000269488.06546.7cen_US
dc.identifier.pmid17646493-
dc.identifier.scopuseid_2-s2.0-34547593848en_US
dc.identifier.hkuros139036-
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-34547593848&selection=ref&src=s&origin=recordpageen_US
dc.identifier.volume105en_US
dc.identifier.issue2en_US
dc.identifier.spage374en_US
dc.identifier.epage380en_US
dc.identifier.isiWOS:000248343400017-
dc.publisher.placeUnited Statesen_US

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