- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03436472
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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Beijing, Kina, 100034
- Peking University first hospital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: dexmedetomidingruppen
För patienter som inte intuberades infunderades dexmedetomidin med en hastighet av 0,1 mikrogram/kg per timme från rekrytering av studien på operationsdagen till kl. 08.00 den första dagen efter operationen.
För patienter som var intuberade och mekaniskt ventilerade påbörjades infusion av dexmedetomidin efter att Richmond Agitation Sedation Scale var -2 eller högre efter inläggning på intensivvårdsavdelningen fram till kl. 08.00 den första dagen efter operationen.
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lågdos dexmedetomidininfusion
Andra namn:
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Placebo-jämförare: placebogruppen
Normal koksaltlösning infunderades i samma hastighet under samma varaktighet som den i placebogruppen.
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normal saltlösningsinfusion
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Duration of 5-year survival after surgery
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Survival rates after surgery
Tidsram: 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
Tidsram: 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
Tidsram: 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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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Survival rates in the subgroup of patients after cancer or non-cancer surgery
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Publikationer och användbara länkar
Allmänna publikationer
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- Mu DL, Wang DX, Li LH, Shan GJ, Li J, Yu QJ, Shi CX. High serum cortisol level is associated with increased risk of delirium after coronary artery bypass graft surgery: a prospective cohort study. Crit Care. 2010;14(6):R238. doi: 10.1186/cc9393. Epub 2010 Dec 30.
- 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.
- Pisani MA, Kong SY, Kasl SV, Murphy TE, Araujo KL, Van Ness PH. Days of delirium are associated with 1-year mortality in an older intensive care unit population. Am J Respir Crit Care Med. 2009 Dec 1;180(11):1092-7. doi: 10.1164/rccm.200904-0537OC. Epub 2009 Sep 10.
- Bickel H, Gradinger R, Kochs E, Forstl H. High risk of cognitive and functional decline after postoperative delirium. A three-year prospective study. Dement Geriatr Cogn Disord. 2008;26(1):26-31. doi: 10.1159/000140804. Epub 2008 Jun 24.
- Van Rompaey B, Schuurmans MJ, Shortridge-Baggett LM, Truijen S, Elseviers M, Bossaert L. Long term outcome after delirium in the intensive care unit. J Clin Nurs. 2009 Dec;18(23):3349-57. doi: 10.1111/j.1365-2702.2009.02933.x. Epub 2009 Sep 4.
- 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.
- de Rooij SE, van Munster BC, Korevaar JC, Levi M. Cytokines and acute phase response in delirium. J Psychosom Res. 2007 May;62(5):521-5. doi: 10.1016/j.jpsychores.2006.11.013.
- 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.
- Bekker A, Haile M, Kline R, Didehvar S, Babu R, Martiniuk F, Urban M. The effect of intraoperative infusion of dexmedetomidine on the quality of recovery after major spinal surgery. J Neurosurg Anesthesiol. 2013 Jan;25(1):16-24. doi: 10.1097/ANA.0b013e31826318af.
- 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.
- Jorden VSB, et al. Dexmedetomidine: clinical update. Semin Anesth Periop Med Pain 2002;21:265-74.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Mentala störningar
- Sjukdomar i nervsystemet
- Neurologiska manifestationer
- Förvirring
- Neurobehavioral manifestationer
- Neurokognitiva störningar
- Delirium
- Läkemedels fysiologiska effekter
- Adrenerga medel
- Neurotransmittormedel
- Molekylära mekanismer för farmakologisk verkan
- Depressiva medel i centrala nervsystemet
- Agenter från det perifera nervsystemet
- Analgetika
- Sensoriska systemagenter
- Analgetika, icke-narkotiska
- Adrenerga alfa-2-receptoragonister
- Adrenerga alfa-agonister
- Adrenerga agonister
- Hypnotika och lugnande medel
- Dexmedetomidin
Andra studie-ID-nummer
- Dex-5-2016
Plan för individuella deltagardata (IPD)
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Kliniska prövningar på Delirium
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Efficacy Care R&D LtdHadassah Medical OrganizationOkändDelirium | Delirium, orsak okänd | Delirium av blandat ursprung | Delirium Förvirringstillstånd | Läkemedelsinducerad deliriumIsrael
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Johns Hopkins UniversityNational Institute on Aging (NIA)Aktiv, inte rekryterandeDelirium | Delirium vid uppkomst | Hörselnedsättning | Hörselnedsättning, högfrekvent | Hörselnedsättning, sensorineural | Delirium, orsak okänd | Hörselnedsättning, bilateral | Hörselnedsättning | Delirium i ålderdom | Delirium av blandat ursprung | Delirium överlagrat på demens | Delirium Förvirringstillstånd | Delirium... och andra villkorFörenta staterna
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Oslo University HospitalUniversity of Melbourne; Norwegian Academy of MusicRekryteringDelirium i ålderdom | Delirium av blandat ursprung | Delirium överlagrat på demens | Delirium FörvirringstillståndNorge
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Universidad de SantanderOkändDelirium av blandat ursprung | Hypoaktivt delirium | Hyperaktivt deliriumColombia
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Imperial College Healthcare NHS TrustRekryteringHjärtkirurgi | Intensivvårdsavdelning Delirium | Postoperativt deliriumStorbritannien
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Chinese PLA General HospitalBeijing Tiantan HospitalRekrytering
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Charite University, Berlin, GermanyBARMERRekryteringDelirium i ålderdomTyskland
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Qin ZhangNational Natural Science Foundation of ChinaRekrytering
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Qin ZhangNational Natural Science Foundation of ChinaRekryteringDelirium, postoperativtKina
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University Hospital, Basel, SwitzerlandInnosuisse - Swiss Innovation AgencyRekryteringPostoperativt delirium (POD)Schweiz
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