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Published in: Trials 1/2020

01-12-2020 | Heart Surgery | Study protocol

Effect of intraoperative dexmedetomidine infusion on delirium in adult patients following cardiac valve surgery: a protocol of a randomized, double-blinded, and placebo-controlled study

Authors: Hong-Bai Wang, Liang Zhang, Zhe Zhang, Su Yuan, Fu-Xia Yan, Qi-Peng Luo

Published in: Trials | Issue 1/2020

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Abstract

Background

Delirium is an acute status of brain dysfunction that commonly occurs in patients who have undergone cardiac surgery, and increases morbidity and mortality. It is associated with risk factors, such as older age, use of narcotics, cardiopulmonary bypass, and hypothermia. Dexmedetomidine infusion might exert a neuroprotective effect. However, the effect of perioperative administration of dexmedetomidine on the incidence of postoperative delirium (POD) in patients undergoing cardiac or non-cardiac surgery is yet controversial. The present study aimed to reveal the effect of intraoperative dexmedetomidine administration on the incidence of delirium in adult patients following cardiac surgery.

Methods

This single-center, randomized, double-blinded, and placebo-controlled trial consisted of 652 patients randomly divided into two groups: dexmedetomidine and placebo. 0.6 μg/kg dexmedetomidine will be infused 10 min after central vein catheterization, followed by a continuous infusion at a speed of 0.4 μg/kg/h until the end of surgery in the dexmedetomidine group, while normal saline will be administered at the same rate in the placebo group. The primary outcome is the incidence of POD during the first 7 days post-surgery. The secondary outcomes include duration of mechanical ventilation after surgery, duration of stay in the intensive care unit and the hospital after surgery, incidence of hypotension during or after dexmedetomidine infusion, acute kidney injury and sudden arrhythmia during the hospital stay postoperatively, and all-cause mortality in 30 and 90 days after surgery, respectively.

Discussion

This study was approved by the Ethics Committee of the Chinese Academy of Medical Sciences Fuwai Hospital on 6 March 2019 (2019-1180). The results will be disseminated at academic conferences and submitted to peer-reviewed publications. Either positive or negative results will provide guidance for clinical practice.

Trial registration

The Chinese Clinical Trial Registry (http://​www.​chictr.​org.​cn) ChiCTR1900022583. Registered on 17 April 2019.
Appendix
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Literature
1.
Lipowski ZJ. Delirium (acute confusional states). JAMA. 1987;258:1789–92.PubMed
2.
Munk L, Andersen G, Møller AM. Post-anaesthetic emergence delirium in adults: incidence, predictors and consequences. Acta Anaesthesiol Scand. 2016;60:1059–66.PubMed
3.
Sockalingam S, Parekh N, Bogoch II, Sun J, Mahtani R, Beach C, Bollegalla N, Turzanski S, Seto E, Kim J, Dulay P, Scarrow S, Bhalerao S. Delirium in the postoperative cardiac patient: a review. J Card Surg. 2005;20:560–7.PubMed
4.
Gleason LJ, Schmitt EM, Kosar CM, Tabloski P, Saczynski JS, Robinson T, Cooper Z, Rogers SO Jr, Jones RN, Marcantonio ER, Inouye SK. Effect of delirium and other major complications on outcomes after elective surgery in older adults. JAMA Surg. 2015;150:1134–40.PubMedPubMedCentral
5.
Shurtleff V, Radosevich JJ, Patanwala AE. Comparison of Ketamine- Versus Nonketamine-Based Sedation on Delirium and Coma in the Intensive Care Unit. 2020;35:536-41.
6.
O'Neal JB, Billings FT 4th, Liu X, Shotwell MS, Liang Y, Shah AS, Ehrenfeld JM, Wanderer JP, Shaw AD. Risk factors for delirium after cardiac surgery: a historical cohort study outlining the influence of cardiopulmonary bypass. Can J Anaesth. 2017;64:1129–37.PubMedPubMedCentral
7.
Leung JM, Sands LP, Newman S, Meckler G, Xie Y, Gay C, Lee K. Preoperative sleep disruption and postoperative delirium. J Clin Sleep Med. 2015;11:907–13.PubMedPubMedCentral
8.
Meier DE. Pain as a cause of agitated delirium. Arch Intern Med. 2012;172:1130.PubMed
9.
Koster S, Hensens AG, van der Palen J. The long-term cognitive and functional outcomes of postoperative delirium after cardiac surgery. Ann Thorac Surg. 2009;87:1469–74.PubMed
10.
Mangusan RF, Hooper V, Denslow SA, Travis L. Outcomes associated with postoperative delirium after cardiac surgery. Am J Crit Care. 2015;24:156–63.PubMed
11.
Krzych LJ, Wybraniec MT, Krupka-Matuszczyk I, Skrzypek M, Bolkowska A, Wilczyński M, Bochenek AA. Detailed insight into the impact of postoperative neuropsychiatric complications on mortality in a cohort of cardiac surgery subjects: a 23,000-patient-year analysis. J Cardiothorac Vasc Anesth. 2014;28:448–57.PubMed
12.
Zhang Z, Ferretti V, Güntan İ, Moro A, Steinberg EA, Ye Z, Zecharia AY, Yu X, Vyssotski AL, Brickley SG, Yustos R, Pillidge ZE, Harding EC, Wisden W, Franks NP. Neuronal ensembles sufficient for recovery sleep and the sedative actions of α2 adrenergic agonists. Nat Neurosci. 2015;18:553–61.PubMedPubMedCentral
13.
Nelson S, Muzyk AJ, Bucklin MH, Brudney S, Gagliardi JP. Defining the role of dexmedetomidine in the prevention of delirium in the intensive care unit. Biomed Res Int. 2015;2015:635737.PubMedPubMedCentral
14.
Lee C, Lee CH, Lee G, Lee M, Hwang J. The effect of the timing and dose of dexmedetomidine on postoperative delirium in elderly patients after laparoscopic major non-cardiac surgery: a double blind randomized controlled study. J Clin Anesth. 2018;47:27–32.PubMed
15.
Li CJ, Wang BJ, Mu DL, Hu J, Guo C, Li XY, Ma D, Wang DX. Randomized clinical trial of intraoperative dexmedetomidine to prevent delirium in the elderly undergoing major non-cardiac surgery. Br J Surg. 2020;107:e123–32.PubMed
16.
Karren EA, King AB, Hughes CG. Dexmedetomidine for prevention of delirium in elderly patients after non-cardiac surgery. J Thorac Dis. 2016;8:E1759–62.PubMedPubMedCentral
17.
Cheng XQ, Mei B, Zuo YM, Wu H, Peng XH, Zhao Q, Liu XS, Gu E, POCD Study Group. A multicentre randomised controlled trial of the effect of intra-operative dexmedetomidine on cognitive decline after surgery. Anaesthesia. 2019;74:741–50.PubMed
18.
Kim JA, Ahn HJ, Yang M, Lee SH, Jeong H, Seong BG. Intraoperative use of dexmedetomidine for the prevention of emergence agitation and postoperative delirium in thoracic surgery: a randomized-controlled trial. Can J Anaesth. 2019;66:371–9.PubMed
19.
Su X, Meng ZT, Wu XH, Cui F, Li HL, Wang DX, Zhu X, Zhu SN, Maze M, Ma D. Dexmedetomidine for prevention of delirium in elderly patients after non-cardiac surgery: a randomised, double-blind, placebo-controlled trial. Lancet. 2016;388:1893–902.PubMed
20.
Pereira JV, Sanjanwala RM, Mohammed MK, Le ML, Arora RC. Dexmedetomidine versus propofol sedation in reducing delirium among older adults in the ICU: a systematic review and meta-analysis. Eur J Anaesthesiol. 2020;37:121–31.PubMed
21.
Burry L, Hutton B, Williamson DR, Mehta S, Adhikari NK, Cheng W, Ely EW, Egerod I, Fergusson DA, Rose L. Pharmacological interventions for the treatment of delirium in critically ill adults. Cochrane Database Syst Rev. 2019;9:CD011749.PubMed
22.
Ji F, Li Z, Nguyen H, Young N, Shi P, Fleming N, Liu H. Perioperative dexmedetomidine improves outcomes of cardiac surgery. Circulation. 2013;127:1576–84.PubMedPubMedCentral
23.
Li X, Yang J, Nie XL, Zhang Y, Li XY, Li LH, Wang DX, Ma D. Impact of dexmedetomidine on the incidence of delirium in elderly patients after cardiac surgery: a randomized controlled trial. PLoS One. 2017;12:e0170757.PubMedPubMedCentral
24.
Cheng H, Li Z, Young N, Boyd D, Atkins Z, Ji F, Liu H. The effect of dexmedetomidine on outcomes of cardiac surgery in elderly patients. J Cardiothorac Vasc Anesth. 2016;30:1502–8.PubMedPubMedCentral
25.
Shu A, Liu X, Wang Q, Chen X, Zhan L. Study on cerebral protective effect of dexmedetomidine during anesthesia in cardiac valve replacement surgery. Int J Clin Exp Med. 2017;10:1066–72.
26.
Sheikh TA, Dar BA, Akhter N, Ahmad N. A comparative study evaluating effects of intravenous sedation by dexmedetomidine and propofol on patient hemodynamics and postoperative outcomes in cardiac surgery. Anesth Essays Res. 2018;12:555–60.PubMedPubMedCentral
27.
Chan AW, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hróbjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586.PubMedPubMedCentral
28.
Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989;28:193–213.PubMed
29.
Folstein MF, Folstein SE, McHugh PR. “Mini-mental state”. A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975;12:189–98.PubMed
30.
Shehabi Y, Howe BD, Bellomo R, Arabi YM, Bailey M, Bass FE, Bin Kadiman S, McArthur CJ, Murray L, Reade MC, Seppelt IM, Takala J, Wise MP, Webb SA, ANZICS Clinical Trials Group and the SPICE III Investigators. Early sedation with dexmedetomidine in critically ill patients. N Engl J Med. 2019;380:2506–17.PubMed
31.
Sessler CN, Gosnell MS, Grap MJ, Brophy GM, O'Neal PV, Keane KA, Tesoro EP, Elswick RK. The Richmond Agitation-Sedation Scale: validity and reliability in adult intensive care unit patients. Am J Respir Crit Care Med. 2002;166:1338–44.
32.
Ely EW, Inouye SK, Bernard GR, Gordon S, Francis J, May L, Truman B, Speroff T, Gautam S, Margolin R, Hart RP, Dittus R. Delirium in mechanically ventilated patients: validity and reliability of the confusion assessment method for the intensive care unit (CAM-ICU). JAMA. 2001;286:2703–10.PubMed
33.
Peterson JF, Pun BT, Dittus RS, Thomason JW, Jackson JC, Shintani AK, Ely EW. Delirium and its motoric subtypes: a study of 614 critically ill patients. J Am Geriatr Soc. 2006;54:479–84.PubMed
34.
Järvelä K, Porkkala H, Karlsson S, Martikainen T, Selander T, Bendel S. Postoperative delirium in cardiac surgery patients. J Cardiothorac Vasc Anesth. 2018;32:1597–602.PubMed
35.
Saleh SS, Racz M, Hannan E. The effect of preoperative and hospital characteristics on costs for coronary artery bypass graft. Ann Surg. 2009;249(2):335–41.PubMed
36.
Hannan EL, Cozzens K, King SB 3rd, Walford G, Shah NR. The New York State cardiac registries: history, contributions, limitations, and lessons for future efforts to assess and publicly report healthcare outcomes. J Am Coll Cardiol. 2012;59:2309–16.PubMed
37.
Rudiger A, Begdeda H, Babic D, Krüger B, Seifert B, Schubert M, Spahn DR, Bettex D. Intra-operative events during cardiac surgery are risk factors for the development of delirium in the ICU. Crit Care. 2016;20:264.PubMedPubMedCentral
38.
Hudetz JA, Iqbal Z, Gandhi SD, Patterson KM, Byrne AJ, Pagel PS. Postoperative delirium and short-term cognitive dysfunction occur more frequently in patients undergoing valve surgery with or without coronary artery bypass graft surgery compared with coronary artery bypass graft surgery alone: results of a pilot study. J Cardiothorac Vasc Anesth. 2011;25:811–6.PubMed
39.
Weerink MAS, Struys MMRF, Hannivoort LN, Barends CRM, Absalom AR, Colin P. Clinical pharmacokinetics and pharmacodynamics of dexmedetomidine. Clin Pharmacokinet. 2017;56:893–913.PubMedPubMedCentral
40.
Bao Y, Zhu Y, He G, Ni H, Liu C, Ma L, Zhang L, Shi D. Dexmedetomidine attenuates neuroinflammation in LPS-stimulated BV2 microglia cells through upregulation of miR-340. Drug Des Devel Ther. 2019;13:3465–75.PubMedPubMedCentral
41.
Huang J, Jiang Q. Dexmedetomidine protects against neurological dysfunction in a mouse intracerebral hemorrhage model by inhibiting mitochondrial dysfunction-derived oxidative stress. J Stroke Cerebrovasc Dis. 2019;28:1281–9.PubMed
42.
Smulter N, Lingehall HC, Gustafson Y, Olofsson B, Engström KG. Delirium after cardiac surgery: incidence and risk factors. Interact Cardiovasc Thorac Surg. 2013;17:790–6.PubMedPubMedCentral
43.
Shi C, Jin J, Qiao L, Li T, Ma J, Ma Z. Effect of perioperative administration of dexmedetomidine on delirium after cardiac surgery in elderly patients: a double-blinded, multi-center, randomized study. Clin Interv Aging. 2019;14:571–5.PubMedPubMedCentral
Metadata
Title
Effect of intraoperative dexmedetomidine infusion on delirium in adult patients following cardiac valve surgery: a protocol of a randomized, double-blinded, and placebo-controlled study
Authors
Hong-Bai Wang
Liang Zhang
Zhe Zhang
Su Yuan
Fu-Xia Yan
Qi-Peng Luo
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-04574-x

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