- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03289325
Dexmedetomidine and Long-term Outcomes in Elderly Patients After Cardiac Surgery
Impact of Perioperative Dexmedetomidine on Long-term Outcomes in Elderly Patients After Cardiac Surgery: 6-year Follow-up of a Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Dexmedetomidine is a highly selective alpha 2-adrenergic receptor agonist that provides anti-anxiety, sedation, and modest analgesic effects. In a retrospective cohort study of patients undergoing cardiac surgery, perioperative dexmedetomidine administration was associated with decreased risk of 1-year mortality. Theoretically, perioperative dexmedetomidine may exert the following favorable for cardiac surgery patients: (1) reduces perioperative opioid consumption and thereby mitigates opioid-induced immunosuppression, (2) dampens hyper-inflammatory response induced by surgery, and (3) improves postoperative sleep quality. However, prospective studies investigating the long-term effects of perioperative dexmedetomidine in cardiac surgery patients are still lacking.
In a previous randomized controlled trial, 285 patients of 60 years or older who were scheduled to undergo coronary artery bypass graft surgery and/or valve replacement surgery were randomized to receive either perioperative dexmedetomidine administration (0.6 microgram/kg in 10 minutes before anesthesia induction, followed by a continuous infusion at a rate of 0.4 microgram/kg/h until the end of surgery, then a continuous infusion at a rate of 0.1 microgram/kg/h until the end of mechanical ventilation) or placebo (normal saline, administered in the same rate or volume for the same duration as in the dexmedetomidine group). The results showed that perioperative dexmedetomidine reduced the incidence of pulmonary complications and shortened the duration of mechanical ventilation after surgery.
The purpose of this 6-year follow-up study is to investigate the effects of perioperative dexmedetomidine on the long-term outcomes in elderly patients after cardiac surgery.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Beijing
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Beijing, Beijing, China, 100034
- Peking University First Hospital
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Beijing, Beijing, China, 100037
- Beijing Fuwai Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age of 60 years or older;
- Scheduled to undergo cardiac surgery (coronary artery bypass graft and/or valve replacement surgery);
- Provide written informed consents.
Exclusion Criteria: Patients who meet any of the following criteria will be excluded.
- Preoperative history of schizophrenia, epilepsia, Parkinson syndrome, or severe dementia;
- Inability to communicate in the preoperative period because of severe visual/auditory dysfunction or language barrier;
- History of brain injury or neurosurgery;
- Preoperative sick sinus syndrome, severe bradycardia (HR < 50 bpm), second-degree or above atrioventricular block without pacemaker;
- Severe hepatic dysfunction (Child-Pugh class C);
- Severe renal dysfunction (requirement of renal replacement therapy);
- Other conditions that are considered unsuitable for participation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: DEX group
The active drug (dexmedetomidine hydrochloride for injection) will be administered during a period from before anesthesia induction until the end of mechanical ventilation after surgery.
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Before anesthesia, dexmedetomidine hydrochloride for injection (200 ug/2 ml) will be diluted with normal saline to 50 ml (final dexmedetomidine concentration 4 ug/ml). Before anesthesia induction, a loading dose will be administered by intravenous infusion at a rate of [0.9*kg] ml/h for 10 minutes (i.e., dexmedetomidine 0.6 ug/kg in 10 minutes), followed by continuous infusion at a rate of [0.1*kg] ml/h (i.e., dexmedetomidine at a rate of 0.4 ug/kg/h) until the end of surgery. After surgery, the infusion rate will be decreased to [0.025*kg] ml/h (i.e., dexmedetomidine at a rate of 0.1 ug/kg/h) and continued until the end of mechanical ventilation.
Other Names:
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Placebo Comparator: CTRL group
The placebo drug (normal saline, or 0.9% sodium chloride for injection) will be administered in the same rate and volume for a same duration as that in the DEX group.
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Before anesthesia, 0.9% sodium chloride for injection 50 ml will be prepared. Before anesthesia induction, a loading dose will be administered by intravenous infusion at a rate of [0.9*kg] ml/h for 10 minutes, followed by continuous infusion at a rate of [0.1*kg] ml/h until the end of surgery. After surgery, the infusion rate will be decreased to [0.025*kg] ml/h and continued until the end of mechanical ventilation.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival after surgery
Time Frame: Up to 6 years after surgery
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Overall survival after surgery
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Up to 6 years after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Major adverse cardiovascular events-free survival after surgery
Time Frame: Up to 6 years after surgery
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Major adverse cardiovascular events include cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and myocardial revascularization.
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Up to 6 years after surgery
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Hospital-free survival after surgery
Time Frame: Up to 6 years after surgery
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Event indicates any medical condition that lead to hospitalization after surgery.
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Up to 6 years after surgery
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Cognitive function in 6-year survivors after surgery
Time Frame: At the 6th year after surgery
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Cognitive function is assessed with Telephone Interview for Cognitive Status-Modified (TICS-M; scores range from 0 to 50, with higher score indicating better cognitive function).
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At the 6th year after surgery
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Health related quality of life in 6-year survivors after surgery
Time Frame: At the 6th year after surgery
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Health related quality of life is assessed with the short-form 36-item health survey questionnaire (SF-36).
The SF-36 scale measures eight aspects of health status, i.e., physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health.
It also measures changes of subjective healthy status during the last year (reported health transition).
The scores of the above 9 items are calculated separately with scores range from 0 to 100, with higher score indicating better quality.
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At the 6th year after surgery
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Dong-Xin Wang, MD, PhD, Peking University First Hospital
Publications and helpful links
General Publications
- 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.
- 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.
- Thomason JW, Shintani A, Peterson JF, Pun BT, Jackson JC, Ely EW. Intensive care unit delirium is an independent predictor of longer hospital stay: a prospective analysis of 261 non-ventilated patients. Crit Care. 2005 Aug;9(4):R375-81. doi: 10.1186/cc3729. Epub 2005 Jun 1.
- Jackson JC, Gordon SM, Hart RP, Hopkins RO, Ely EW. The association between delirium and cognitive decline: a review of the empirical literature. Neuropsychol Rev. 2004 Jun;14(2):87-98. doi: 10.1023/b:nerv.0000028080.39602.17.
- 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.
- 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.
- 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.
- 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.
- Guenther U, Radtke FM. Delirium in the postanaesthesia period. Curr Opin Anaesthesiol. 2011 Dec;24(6):670-5. doi: 10.1097/ACO.0b013e32834c7b44.
- Morandi A, Pandharipande PP, Jackson JC, Bellelli G, Trabucchi M, Ely EW. Understanding terminology of delirium and long-term cognitive impairment in critically ill patients. Best Pract Res Clin Anaesthesiol. 2012 Sep;26(3):267-76. doi: 10.1016/j.bpa.2012.08.001.
- Groen JA, Banayan D, Gupta S, Xu S, Bhalerao S. Treatment of delirium following cardiac surgery. J Card Surg. 2012 Sep;27(5):589-93. doi: 10.1111/j.1540-8191.2012.01508.x.
- Hopkins RO, Jackson JC. Short- and long-term cognitive outcomes in intensive care unit survivors. Clin Chest Med. 2009 Mar;30(1):143-53, ix. doi: 10.1016/j.ccm.2008.11.001.
- Girard TD, Shintani AK, Ely EW. Comment on "Incidence, risk factors and consequences of ICU delirium" by Ouimet et al. Intensive Care Med. 2007 Aug;33(8):1479-80; author reply 1481-2. doi: 10.1007/s00134-007-0698-8. Epub 2007 Jun 5. No abstract available.
- Bidwell J. Interventions for preventing delirium in hospitalized non-ICU patients: A Cochrane review summary. Int J Nurs Stud. 2017 May;70:142-143. doi: 10.1016/j.ijnurstu.2016.11.010. Epub 2016 Nov 17. No abstract available.
- Ji F, Li Z, Nguyen H, Young N, Shi P, Fleming N, Liu H. Response to letters regarding article, "perioperative dexmedetomidine improves outcomes of cardiac surgery". Circulation. 2013 Oct 15;128(16):e339-40. doi: 10.1161/CIRCULATIONAHA.113.005450. No abstract available.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Hypnotics and Sedatives
- Dexmedetomidine
Other Study ID Numbers
- 2016-1188
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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