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Dexmedetomidine and 5-year Outcome in Elderly Patients After Surgery
Impact of Dexmedetomidine on Long-term Outcome in Elderly Patients After Noncardiac Surgery: 5-year Follow-up of a Randomized Controlled Trial
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
Delirium is a frequent postoperative complication; a systematic review revealed that postoperative delirium occurs in 36.8% of surgical patients, and its prevalence increases with age. The occurrence of delirium is associated with worse long-term outcomes including worse functional recovery, decline in cognitive function, and increased mortality rate. Surgical stress, pain, and sleep disturbances are important factors leading to postoperative delirium in the elderly.
Dexmedetomidine is a highly selective alpha-2 adrenoreceptor agonist that provides anti-anxiety, sedation, and modest analgesia with minimal respiratory depression. For mechanically ventilated intensive care unit (ICU) patients, dexmedetomidine sedation improves the quality of sleep, decreases the incidence of delirium, and shortens the duration of ICU stay. For patients undergoing surgery, perioperative dexmedetomidine relieves the severity of stress response, decreases the requirement of anesthetics, and improves postoperative analgesia.
In the previous stage of the current study, 700 elderly patients who were admitted to the ICU after noncardiac surgery were recruited and randomized into two groups (dexmedetomidine group and placebo [normal saline] group). The results showed that prophylactic low-dose dexmedetomidine infusion during the early postoperative period ameliorated the subjective sleep quality and decreased the incidence of delirium (22.6% [79/350] with placebo vs. 9.1% [32/350] with dexmedetomidine; odds ratio 0.35, 95% confidence interval 0.22 to 0.54; p < 0.0001). The investigators hypothesize that low-dose dexmedetomidine infusion may also improve long-term outcome in this patient population.
The purpose of this 5-year follow-up study is to evaluate whether prophylactic low-dose dexmedetomidine infusion during the early postoperative period can improve the 5-year outcomes in elderly patients recruited in the previous randomized controlled trial.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Beijing, China, 100034
- Peking University First Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
Patients were included if they met all of the following criteria:
- Age of 65 years or older;
- Underwent elective noncardiac surgery under general anesthesia;
- Admitted to ICU after surgery.
Exclusion Criteria:
Patients were excluded if they met any of the following criteria:
- Preoperative history of schizophrenia, epilepsy, Parkinsonism or myasthenia gravis;
- Inability to communicate in the preoperative period (because of coma, profound dementia or language barrier);
- Brain injury or neurosurgery;
- Preoperative left ventricular ejection fraction < 30%, sick sinus syndrome, severe sinus bradycardia (< 50 beats per minute), or second-degree or greater atrioventricular block without pacemaker;
- Serious hepatic dysfunction (Child-Pugh class C);
- Serious renal dysfunction (undergoing dialysis before surgery); or
- Unlikely to survive for more than 24 hours.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: dexmedetomidine-groep
Voor patiënten die niet waren geïntubeerd, werd dexmedetomidine via een infuus toegediend met een snelheid van 0,1 microgram/kg per uur vanaf het begin van de studie op de dag van de operatie tot 8.00 uur op de eerste dag na de operatie.
Voor patiënten die werden geïntubeerd en mechanisch beademd, werd dexmedetomidine-infusie gestart nadat de Richmond Agitation Sedation Scale -2 of hoger was na opname op de intensive care tot 8.00 uur op de eerste dag na de operatie.
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lage dosis dexmedetomidine-infuus
Andere namen:
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Placebo-vergelijker: placebo groep
Normale zoutoplossing werd toegediend in dezelfde snelheid gedurende dezelfde duur als die in de placebogroep.
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normale infusie van zoutoplossing
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Duration of 5-year survival after surgery
Tijdsspanne: From the day of surgery until the end of the 5th year after surgery
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Duration of 5-year survival after surgery
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From the day of surgery until the end of the 5th year after surgery
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Survival rates after surgery
Tijdsspanne: At 6 months, 1 year, 2 years ,3 years, 4 years,and 5 years after surgery
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Survival rates at different timepoints after surgery
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At 6 months, 1 year, 2 years ,3 years, 4 years,and 5 years after surgery
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Cognitive function in 5-year survivors after surgery
Tijdsspanne: At the end of the 5th year after surgery
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Cognitive function is assessed with Telephone Interview for Cognitive Status-Modified (TICS-M).
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At the end of the 5th year after surgery
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Health related quality of life in 5-year survivors after surgery
Tijdsspanne: At the end of the 5th year after surgery
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Health related quality of life is assessed with World Health Organization Quality of Life-BREF (WHOQOL-BREF).
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At the end of the 5th year after surgery
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Survival rates in the subgroup of patients after cancer or non-cancer surgery
Tijdsspanne: At 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years after surgery
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Survival rates at different time-points in the subgroup of patients after cancer or non-cancer surgery
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At 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years after surgery
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Duration of survival in the subgroup of patients after cancer or non-cancer surgery
Tijdsspanne: From the day of surgery until the end of the 5th year after surgery
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Duration of survival in the subgroup of patients after cancer or non-cancer surgery
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From the day of surgery until the end of the 5th year after surgery
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Cognitive function in the subgroup of 5-year survivors after cancer or non-cancer surgery
Tijdsspanne: At the end of the 5th year after surgery
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Cognitive function is assessed with Telephone Interview for Cognitive Status-Modified (TICS-M)
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At the end of the 5th year after surgery
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Health related quality of life in the subgroup of 5-year survivors after cancer or non-cancer surgery
Tijdsspanne: At the end of the 5th year after surgery
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Health related quality of life is assessed with World Health Organization Quality of Life-BREF (WHOQOL-BREF).
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At the end of the 5th year after surgery
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Publicaties en nuttige links
Algemene publicaties
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- Shi CM, Wang DX, Chen KS, Gu XE. Incidence and risk factors of delirium in critically ill patients after non-cardiac surgery. Chin Med J (Engl). 2010 Apr 20;123(8):993-9.
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- Halaszynski TM. Pain management in the elderly and cognitively impaired patient: the role of regional anesthesia and analgesia. Curr Opin Anaesthesiol. 2009 Oct;22(5):594-9. doi: 10.1097/ACO.0b013e32833020dc.
- Rudolph JL, Ramlawi B, Kuchel GA, McElhaney JE, Xie D, Sellke FW, Khabbaz K, Levkoff SE, Marcantonio ER. Chemokines are associated with delirium after cardiac surgery. J Gerontol A Biol Sci Med Sci. 2008 Feb;63(2):184-9. doi: 10.1093/gerona/63.2.184.
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- Oto J, Yamamoto K, Koike S, Onodera M, Imanaka H, Nishimura M. Sleep quality of mechanically ventilated patients sedated with dexmedetomidine. Intensive Care Med. 2012 Dec;38(12):1982-9. doi: 10.1007/s00134-012-2685-y. Epub 2012 Sep 8.
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- Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62. doi: 10.1001/jama.291.14.1753.
- Ansaloni L, Catena F, Chattat R, Fortuna D, Franceschi C, Mascitti P, Melotti RM. Risk factors and incidence of postoperative delirium in elderly patients after elective and emergency surgery. Br J Surg. 2010 Feb;97(2):273-80. doi: 10.1002/bjs.6843.
- Girard TD, Pandharipande PP, Ely EW. Delirium in the intensive care unit. Crit Care. 2008;12 Suppl 3(Suppl 3):S3. doi: 10.1186/cc6149. Epub 2008 May 14.
- Ely EW, Gautam S, Margolin R, Francis J, May L, Speroff T, Truman B, Dittus R, Bernard R, Inouye SK. The impact of delirium in the intensive care unit on hospital length of stay. Intensive Care Med. 2001 Dec;27(12):1892-900. doi: 10.1007/s00134-001-1132-2. Epub 2001 Nov 8.
- Milbrandt EB, Deppen S, Harrison PL, Shintani AK, Speroff T, Stiles RA, Truman B, Bernard GR, Dittus RS, Ely EW. Costs associated with delirium in mechanically ventilated patients. Crit Care Med. 2004 Apr;32(4):955-62. doi: 10.1097/01.ccm.0000119429.16055.92.
- Balas MC, Happ MB, Yang W, Chelluri L, Richmond T. Outcomes Associated With Delirium in Older Patients in Surgical ICUs. Chest. 2009 Jan;135(1):18-25. doi: 10.1378/chest.08-1456. Epub 2008 Nov 18.
- Franco K, Litaker D, Locala J, Bronson D. The cost of delirium in the surgical patient. Psychosomatics. 2001 Jan-Feb;42(1):68-73. doi: 10.1176/appi.psy.42.1.68.
- Vaurio LE, Sands LP, Wang Y, Mullen EA, Leung JM. Postoperative delirium: the importance of pain and pain management. Anesth Analg. 2006 Apr;102(4):1267-73. doi: 10.1213/01.ane.0000199156.59226.af.
- Iirola T, Aantaa R, Laitio R, Kentala E, Lahtinen M, Wighton A, Garratt C, Ahtola-Satila T, Olkkola KT. Pharmacokinetics of prolonged infusion of high-dose dexmedetomidine in critically ill patients. Crit Care. 2011;15(5):R257. doi: 10.1186/cc10518. Epub 2011 Oct 26.
- Siddiqi N, Stockdale R, Britton AM, Holmes J. Interventions for preventing delirium in hospitalised patients. Cochrane Database Syst Rev. 2007 Apr 18;(2):CD005563. doi: 10.1002/14651858.CD005563.pub2.
- Shim JJ, Leung JM. An update on delirium in the postoperative setting: prevention, diagnosis and management. Best Pract Res Clin Anaesthesiol. 2012 Sep;26(3):327-43. doi: 10.1016/j.bpa.2012.08.003.
- Hudek K. Emergence delirium: a nursing perspective. AORN J. 2009 Mar;89(3):509-16; quiz 517-9. doi: 10.1016/j.aorn.2008.12.026.
- Roberts B, Rickard CM, Rajbhandari D, Turner G, Clarke J, Hill D, Tauschke C, Chaboyer W, Parsons R. Multicentre study of delirium in ICU patients using a simple screening tool. Aust Crit Care. 2005 Feb;18(1):6, 8-9, 11-4 passim. doi: 10.1016/s1036-7314(05)80019-0.
- Rabe-Jablonska J, Bienkiewicz W. [Anxiety disorders in the fourth edition of the classification of mental disorders prepared by the American Psychiatric Association: diagnostic and statistical manual of mental disorders (DMS-IV -- options book]. Psychiatr Pol. 1994 Mar-Apr;28(2):255-68. Polish.
- Roth-Isigkeit A, Borstel TV, Seyfarth M, Schmucker P. Perioperative serum levels of tumour-necrosis-factor alpha (TNF-alpha), IL-1 beta, IL-6, IL-10 and soluble IL-2 receptor in patients undergoing cardiac surgery with cardiopulmonary bypass without and with correction for haemodilution. Clin Exp Immunol. 1999 Nov;118(2):242-6. doi: 10.1046/j.1365-2249.1999.01050.x.
- Holmes JH 4th, Connolly NC, Paull DL, Hill ME, Guyton SW, Ziegler SF, Hall RA. Magnitude of the inflammatory response to cardiopulmonary bypass and its relation to adverse clinical outcomes. Inflamm Res. 2002 Dec;51(12):579-86. doi: 10.1007/pl00012432.
- Liu C, Zhang Y, She S, Xu L, Ruan X. A randomised controlled trial of dexmedetomidine for suspension laryngoscopy. Anaesthesia. 2013 Jan;68(1):60-6. doi: 10.1111/j.1365-2044.2012.07331.x. Epub 2012 Oct 29.
- Gozalo-Marcilla M, Hopster K, Gasthuys F, Hatz L, Krajewski AE, Schauvliege S. Effects of a constant-rate infusion of dexmedetomidine on the minimal alveolar concentration of sevoflurane in ponies. Equine Vet J. 2013 Mar;45(2):204-8. doi: 10.1111/j.2042-3306.2012.00613.x. Epub 2012 Aug 1.
- Park JK, Cheong SH, Lee KM, Lim SH, Lee JH, Cho K, Kim MH, Kim HT. Does dexmedetomidine reduce postoperative pain after laparoscopic cholecystectomy with multimodal analgesia? Korean J Anesthesiol. 2012 Nov;63(5):436-40. doi: 10.4097/kjae.2012.63.5.436. Epub 2012 Nov 16.
- Anger KE. Dexmedetomidine: a review of its use for the management of pain, agitation, and delirium in the intensive care unit. Curr Pharm Des. 2013;19(22):4003-13. doi: 10.2174/1381612811319220009.
- Oto J, Yamamoto K, Koike S, Imanaka H, Nishimura M. Effect of daily sedative interruption on sleep stages of mechanically ventilated patients receiving midazolam by infusion. Anaesth Intensive Care. 2011 May;39(3):392-400. doi: 10.1177/0310057X1103900309.
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Studie record data
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Primaire voltooiing (Werkelijk)
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Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
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Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Psychische aandoening
- Ziekten van het zenuwstelsel
- Neurologische manifestaties
- Verwardheid
- Neurologische gedragsmanifestaties
- Neurocognitieve stoornissen
- Delirium
- Fysiologische effecten van medicijnen
- Adrenerge middelen
- Neurotransmitter agenten
- Moleculaire mechanismen van farmacologische werking
- Depressiva van het centrale zenuwstelsel
- Agenten van het perifere zenuwstelsel
- Pijnstillers
- Sensorische systeemagenten
- Pijnstillers, niet-narcotisch
- Adrenerge alfa-2-receptoragonisten
- Adrenerge alfa-agonisten
- Adrenerge agonisten
- Hypnotica en sedativa
- Dexmedetomidine
Andere studie-ID-nummers
- Dex-5-2016
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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Klinische onderzoeken op Delirium
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Efficacy Care R&D LtdHadassah Medical OrganizationOnbekendDelirium | Delirium, oorzaak onbekend | Delirium van gemengde oorsprong | Delirium Verwarde toestand | Door drugs geïnduceerd deliriumIsraël
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Johns Hopkins UniversityNational Institute on Aging (NIA)Actief, niet wervendDelirium | Delirium bij opkomst | Gehoorverlies | Gehoorverlies, hoge frequentie | Gehoorverlies, perceptief | Delirium, oorzaak onbekend | Gehoorverlies, Bilateraal | Slechthorendheid | Delirium op oudere leeftijd | Delirium van gemengde oorsprong | Delirium bovenop dementie | Delirium Verwarde toestand | Delirium... en andere voorwaardenVerenigde Staten
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Oslo University HospitalUniversity of Melbourne; Norwegian Academy of MusicWervingDelirium op oudere leeftijd | Delirium van gemengde oorsprong | Delirium bovenop dementie | Delirium Verwarde toestandNoorwegen
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Universidad de SantanderOnbekendDelirium van gemengde oorsprong | Hypoactief delirium | Hyperactief deliriumColombia
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Chinese PLA General HospitalBeijing Tiantan HospitalWervingDelirium op oudere leeftijdChina
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Charite University, Berlin, GermanyBARMERWervingDelirium op oudere leeftijdDuitsland
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University Hospital, Basel, SwitzerlandInnosuisse - Swiss Innovation AgencyWervingPostoperatief delirium (POD)Zwitserland
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Konya City HospitalVoltooidPREOPERATIEVE SLAAPKWALITEIT BIJ POSTOPERATIEF DELIRIUMKalkoen
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Qin ZhangNational Natural Science Foundation of ChinaWerving
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Qin ZhangNational Natural Science Foundation of ChinaWervingDelirium, postoperatiefChina