右美托咪定-艾氯胺酮联合鼻腔给药和苏醒性谵妄
右美托咪定-艾氯胺酮联合鼻腔给药对老年患者手术后苏醒性谵妄的影响:一项随机、双盲、安慰剂对照试验
研究概览
详细说明
谵妄是老年患者大手术后常见的脑功能障碍综合征。 手术后发生的谵妄包括苏醒期谵妄和术后谵妄。 全身麻醉后 17.5% 至 37.0% 的患者出现苏醒性谵妄。 据报道,非心脏手术后老年患者术后谵妄的发生率为 12.0% 至 32.9%。 众所周知,术后谵妄的发生与不良后果相关。 最近的研究发现,苏醒期谵妄还与不良围手术期结局相关,包括术后谵妄增加、更多非谵妄并发症、住院时间更长和医疗费用更高。
右美托咪定是一种高选择性 α2-肾上腺素受体激动剂,具有镇静、抗焦虑和镇痛作用。 术前或术中预防性给予右美托咪定也被证明可以降低术后谵妄的发生率。 右美托咪定经鼻给药现已广泛用于儿科术前镇静。 右美托咪定的鼻腔给药也用于成人。 在一项回顾性研究中,老年骨科手术患者术后经鼻给予右美托咪定(100 μg)可改善镇痛效果并减少躁动症状。 最近一项针对接受妇科腹腔镜手术的患者的研究表明,从术前第 1 天到术后第 5 天夜间滴鼻给药右美托咪定(1.5 µg/kg)可改善睡眠质量并降低术后谵妄的发生率。
Esketamine 是一种 N-甲基-D-天冬氨酸受体拮抗剂,已用作麻醉剂和镇痛剂。 建议小剂量静脉滴注氯胺酮用于术后镇痛。 艾氯胺酮是氯胺酮的 s-对映体,镇痛效力是氯胺酮的两倍。 FDA 批准经鼻给药艾氯胺酮用于治疗成人顽固性抑郁症。 一项随机试验表明,鼻腔施用艾氯胺酮可有效缓解成年患者的胸廓穿刺后疼痛,且无明显不良反应。 而术后疼痛是苏醒性谵妄和术后谵妄的常见危险因素。
这项随机试验旨在检验右美托咪定-艾氯胺酮联合鼻腔给药可能会降低老年患者手术后苏醒性谵妄发生率的假设。
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
-
-
Beijing
-
Beijing、Beijing、中国、100034
- Peking University First Hospital
-
-
参与标准
资格标准
适合学习的年龄
- 年长者
接受健康志愿者
描述
纳入标准:
- 年龄≥65岁;
- 安排在全身麻醉下进行住院择期或半择期手术,预计手术时间≤2小时;
- 计划术后住院至少 1 天。
排除标准:
- 因鼻部疾病(如鼻炎、鼻息肉或任何原因引起的鼻塞)不适合鼻内给药;
- 术前患有精神分裂症、癫痫、帕金森病、重症肌无力或谵妄;
- 术前因昏迷、严重痴呆或语言障碍而无法沟通;
- 脑外伤或神经外科手术;
- 上个月在睡前使用镇静剂或催眠药;
- 有甲状腺功能亢进症或嗜铬细胞瘤病史;
- 术前左心室射血分数<30%,或病态窦房结综合征、严重窦性心动过缓(心率<50次/分钟)、II度及以上房室传导阻滞且未安装起搏器,或入组前收缩压<90 mmHg;
- 严重肝功能障碍(Child-Pugh C级)、严重肾功能障碍(术前接受透析)或美国麻醉医师协会分级≥IV级;
- 手术后计划入住重症监护室;
- 对右美托咪定和/或艾氯胺酮过敏,或任何其他被认为不适合参与研究的情况。
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:右美托咪定-艾氯胺酮联合用药
右美托咪定 0.5 µg/kg 和艾氯胺酮 0.2 mg/kg 的混合物在手术前一天晚上 20:30 以及手术当天上午 07:30 和晚上 20:30 通过鼻喷雾给药。
|
右美托咪定 0.5 µg/kg 在手术前一天晚上 20:30 以及手术当天上午 07:30 和晚上 20:30 通过鼻喷雾给药。
Esketamine 0.2 mg/kg 在手术前一天晚上 20:30 以及手术当天上午 07:30 和晚上 20:30 通过鼻喷雾给药。
|
|
安慰剂比较:生理盐水
手术前一天晚上 20:30 以及手术当天上午 07:30 和晚上 20:30 通过鼻喷雾给予相同体积的安慰剂(生理盐水)。
|
手术前一天晚上 20:30 以及手术当天上午 07:30 和晚上 20:30 通过鼻腔喷雾给予相同体积的生理盐水。
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
手术后苏醒性谵妄的发生率
大体时间:留在麻醉后监护室期间
|
苏醒性谵妄通过里士满激动镇静量表(RASS;分数范围为 -5 [无法唤醒] 至 +4 [好斗],0 表示警觉和平静)和重症监护病房混乱评估方法 (CAM-ICU) 进行评估。进入麻醉后护理室后 5 分钟和 30 分钟。
|
留在麻醉后监护室期间
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
羽化躁动的发生率
大体时间:麻醉苏醒期间进入手术室
|
手术后从停止全身麻醉到离开手术室期间使用 RASS 评估苏醒期躁动。
任何时候RASS评分≥+2被定义为出现苏醒期躁动。
|
麻醉苏醒期间进入手术室
|
|
主观睡眠质量评分
大体时间:手术前一天晚上和手术当晚
|
主观睡眠质量通过理查兹-坎贝尔睡眠问卷 (RCSQ) 进行评估。
RCSQ 是一项自我报告的衡量标准,从五个项目评估夜间睡眠的感知,包括睡眠深度、睡眠潜伏期、觉醒次数、恢复睡眠和整体睡眠质量。
每个项目均采用100毫米视觉模拟量表进行评估(分数范围为0至100,分数越高表明睡眠质量越好)。
五项的平均分代表整体睡眠质量。
|
手术前一天晚上和手术当晚
|
|
神经认知恢复延迟的发生率
大体时间:手术后5天时
|
认知通过电话蒙特利尔认知评估(T-MoCA;分数范围从0到22,分数越高表明功能越好)进行评估。
T-MoCA 评分较基线降低≥1 个标准差 (SD) 被定义为神经认知恢复延迟。
|
手术后5天时
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
术后24小时内疼痛强度
大体时间:手术后 24 小时内
|
在手术当天的 5 分钟和 30 分钟以及上午 8 点到 10 点以及晚上 18 点到 20 点之间使用数字评定量表(NRS,11 级量表,其中 0=无疼痛,10=最严重疼痛)评估疼痛强度手术后第一天。
|
手术后 24 小时内
|
|
术后24小时内使用镇痛药
大体时间:手术后 24 小时内
|
包括阿片类镇痛药和非阿片类镇痛药。
|
手术后 24 小时内
|
|
术后 3 天内谵妄发生率
大体时间:手术后 3 天以内
|
术后谵妄每天两次(上午 8-10 点和下午 18-20 点)进行评估,针对非插管患者使用 3 分钟的意识模糊评估方法 (3D-CAM) 进行诊断访谈,或者针对重症监护室患者使用意识模糊评估方法 (CAM) -ICU)用于插管患者。
|
手术后 3 天以内
|
|
手术后住院时间
大体时间:手术后最多 30 天
|
手术后住院时间。
|
手术后最多 30 天
|
|
术后30天主观睡眠质量
大体时间:术后30天时
|
30 天的主观睡眠质量通过匹兹堡睡眠质量指数 (PSQI) 进行评估。
PSQI 是一份包含 7 项的调查问卷,由 19 个自评问题组成,用于评估上个月的睡眠质量,每个问题的权重均等,分为 0-3 级;分数越高表明睡眠质量越差
|
术后30天时
|
|
术后30天内术后并发症发生率
大体时间:手术后最多 30 天
|
术后并发症被定义为被认为有害且需要治疗干预的新发医疗事件,即 Clavien-Dindo 分类中的 II 级或更高级别。
|
手术后最多 30 天
|
合作者和调查者
调查人员
- 首席研究员:Dong-Xin Wang, MD, PhD、Peking University First Hospital
出版物和有用的链接
一般刊物
- 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 Oct 15;388(10054):1893-1902. doi: 10.1016/S0140-6736(16)30580-3. Epub 2016 Aug 16.
- Evered L, Silbert B, Knopman DS, Scott DA, DeKosky ST, Rasmussen LS, Oh ES, Crosby G, Berger M, Eckenhoff RG; Nomenclature Consensus Working Group. Recommendations for the nomenclature of cognitive change associated with anaesthesia and surgery-2018. Br J Anaesth. 2018 Nov;121(5):1005-1012. doi: 10.1016/j.bja.2017.11.087. Epub 2018 Jun 15.
- Austin PC. An Introduction to Propensity Score Methods for Reducing the Effects of Confounding in Observational Studies. Multivariate Behav Res. 2011 May;46(3):399-424. doi: 10.1080/00273171.2011.568786. Epub 2011 Jun 8.
- Card E, Pandharipande P, Tomes C, Lee C, Wood J, Nelson D, Graves A, Shintani A, Ely EW, Hughes C. Emergence from general anaesthesia and evolution of delirium signs in the post-anaesthesia care unit. Br J Anaesth. 2015 Sep;115(3):411-7. doi: 10.1093/bja/aeu442. Epub 2014 Dec 23.
- Zhang DF, Su X, Meng ZT, Li HL, Wang DX, Xue-Ying Li, Maze M, Ma D. Impact of Dexmedetomidine on Long-term Outcomes After Noncardiac Surgery in Elderly: 3-Year Follow-up of a Randomized Controlled Trial. Ann Surg. 2019 Aug;270(2):356-363. doi: 10.1097/SLA.0000000000002801.
- Jun JH, Kim KN, Kim JY, Song SM. The effects of intranasal dexmedetomidine premedication in children: a systematic review and meta-analysis. Can J Anaesth. 2017 Sep;64(9):947-961. doi: 10.1007/s12630-017-0917-x. Epub 2017 Jun 21.
- Lynch EP, Lazor MA, Gellis JE, Orav J, Goldman L, Marcantonio ER. The impact of postoperative pain on the development of postoperative delirium. Anesth Analg. 1998 Apr;86(4):781-5. doi: 10.1097/00000539-199804000-00019.
- 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.
- Molero P, Ramos-Quiroga JA, Martin-Santos R, Calvo-Sanchez E, Gutierrez-Rojas L, Meana JJ. Antidepressant Efficacy and Tolerability of Ketamine and Esketamine: A Critical Review. CNS Drugs. 2018 May;32(5):411-420. doi: 10.1007/s40263-018-0519-3.
- Bornemann-Cimenti H, Wejbora M, Michaeli K, Edler A, Sandner-Kiesling A. The effects of minimal-dose versus low-dose S-ketamine on opioid consumption, hyperalgesia, and postoperative delirium: a triple-blinded, randomized, active- and placebo-controlled clinical trial. Minerva Anestesiol. 2016 Oct;82(10):1069-1076. Epub 2016 Jun 21.
- Lee KH, Lee SJ, Park JH, Kim SH, Lee H, Oh DS, Kim YH, Park YH, Kim H, Lee SE. Analgesia for spinal anesthesia positioning in elderly patients with proximal femoral fractures: Dexmedetomidine-ketamine versus dexmedetomidine-fentanyl. Medicine (Baltimore). 2020 May;99(20):e20001. doi: 10.1097/MD.0000000000020001.
- Hu ZC, Xu G, Zhang XW, Ma K, Jin JJ, Li PS. [Meta-analysis of the effects of dexmedetomidine combined with ketamine during dressing changes in burn patients]. Zhonghua Shao Shang Za Zhi. 2020 Jun 20;36(6):458-464. doi: 10.3760/cma.j.cn501120-20190327-00145. Chinese.
- Schwenk ES, Viscusi ER, Buvanendran A, Hurley RW, Wasan AD, Narouze S, Bhatia A, Davis FN, Hooten WM, Cohen SP. Consensus Guidelines on the Use of Intravenous Ketamine Infusions for Acute Pain Management From the American Society of Regional Anesthesia and Pain Medicine, the American Academy of Pain Medicine, and the American Society of Anesthesiologists. Reg Anesth Pain Med. 2018 Jul;43(5):456-466. doi: 10.1097/AAP.0000000000000806.
- Chen LX, Ji DH, Zhang F, Li JH, Cui L, Bai CJ, Liu H, Liang Y. Richards-Campbell sleep questionnaire: psychometric properties of Chinese critically ill patients. Nurs Crit Care. 2019 Nov;24(6):362-368. doi: 10.1111/nicc.12357. Epub 2018 Jul 30.
- 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 Dec;150(12):1134-40. doi: 10.1001/jamasurg.2015.2606.
- Marcantonio ER. Postoperative delirium: a 76-year-old woman with delirium following surgery. JAMA. 2012 Jul 4;308(1):73-81. doi: 10.1001/jama.2012.6857.
- Silva AR, Regueira P, Albuquerque E, Baldeiras I, Cardoso AL, Santana I, Cerejeira J. Estimates of Geriatric Delirium Frequency in Noncardiac Surgeries and Its Evaluation Across the Years: A Systematic Review and Meta-analysis. J Am Med Dir Assoc. 2021 Mar;22(3):613-620.e9. doi: 10.1016/j.jamda.2020.08.017. Epub 2020 Oct 1.
- Berian JR, Zhou L, Russell MM, Hornor MA, Cohen ME, Finlayson E, Ko CY, Rosenthal RA, Robinson TN. Postoperative Delirium as a Target for Surgical Quality Improvement. Ann Surg. 2018 Jul;268(1):93-99. doi: 10.1097/SLA.0000000000002436.
- Silverstein JH, Timberger M, Reich DL, Uysal S. Central nervous system dysfunction after noncardiac surgery and anesthesia in the elderly. Anesthesiology. 2007 Mar;106(3):622-8. doi: 10.1097/00000542-200703000-00026. No abstract available.
- Huge V, Lauchart M, Magerl W, Schelling G, Beyer A, Thieme D, Azad SC. Effects of low-dose intranasal (S)-ketamine in patients with neuropathic pain. Eur J Pain. 2010 Apr;14(4):387-94. doi: 10.1016/j.ejpain.2009.08.002. Epub 2009 Sep 3.
- Uusalo P, Seppanen SM, Jarvisalo MJ. Feasibility of Intranasal Dexmedetomidine in Treatment of Postoperative Restlessness, Agitation, and Pain in Geriatric Orthopedic Patients. Drugs Aging. 2021 May;38(5):441-450. doi: 10.1007/s40266-021-00846-6. Epub 2021 Mar 16.
- Barrett W, Buxhoeveden M, Dhillon S. Ketamine: a versatile tool for anesthesia and analgesia. Curr Opin Anaesthesiol. 2020 Oct;33(5):633-638. doi: 10.1097/ACO.0000000000000916.
- Wolff K, Winstock AR. Ketamine : from medicine to misuse. CNS Drugs. 2006;20(3):199-218. doi: 10.2165/00023210-200620030-00003.
- Sapkota A, Khurshid H, Qureshi IA, Jahan N, Went TR, Sultan W, Alfonso M. Efficacy and Safety of Intranasal Esketamine in Treatment-Resistant Depression in Adults: A Systematic Review. Cureus. 2021 Aug 21;13(8):e17352. doi: 10.7759/cureus.17352. eCollection 2021 Aug.
- Mohanty S, Gillio A, Lindroth H, Ortiz D, Holler E, Azar J, Boustani M, Zarzaur B. Major Surgery and Long Term Cognitive Outcomes: The Effect of Postoperative Delirium on Dementia in the Year Following Discharge. J Surg Res. 2022 Feb;270:327-334. doi: 10.1016/j.jss.2021.08.043. Epub 2021 Oct 29.
- Huang H, Li H, Zhang X, Shi G, Xu M, Ru X, Chen Y, Patel MB, Ely EW, Lin S, Zhang G, Zhou J. Association of postoperative delirium with cognitive outcomes: A meta-analysis. J Clin Anesth. 2021 Dec;75:110496. doi: 10.1016/j.jclinane.2021.110496. Epub 2021 Sep 2.
- Crocker E, Beggs T, Hassan A, Denault A, Lamarche Y, Bagshaw S, Elmi-Sarabi M, Hiebert B, Macdonald K, Giles-Smith L, Tangri N, Arora RC. Long-Term Effects of Postoperative Delirium in Patients Undergoing Cardiac Operation: A Systematic Review. Ann Thorac Surg. 2016 Oct;102(4):1391-9. doi: 10.1016/j.athoracsur.2016.04.071. Epub 2016 Jun 22.
- Pereira JV, Aung Thein MZ, Nitchingham A, Caplan GA. Delirium in older adults is associated with development of new dementia: a systematic review and meta-analysis. Int J Geriatr Psychiatry. 2021 Jul;36(7):993-1003. doi: 10.1002/gps.5508. Epub 2021 Feb 27.
- Zhang Y, He ST, Nie B, Li XY, Wang DX. Emergence delirium is associated with increased postoperative delirium in elderly: a prospective observational study. J Anesth. 2020 Oct;34(5):675-687. doi: 10.1007/s00540-020-02805-8. Epub 2020 Jun 7.
- Igwe EO, Nealon J, O'Shaughnessy P, Bowden A, Chang HR, Ho MH, Montayre J, Montgomery A, Rolls K, Chou KR, Chen KH, Traynor V, Smerdely P. Incidence of postoperative delirium in older adults undergoing surgical procedures: A systematic literature review and meta-analysis. Worldviews Evid Based Nurs. 2023 Jun;20(3):220-237. doi: 10.1111/wvn.12649. Epub 2023 May 2.
- Zhang Y, Cui F, Ma JH, Wang DX. Mini-dose esketamine-dexmedetomidine combination to supplement analgesia for patients after scoliosis correction surgery: a double-blind randomised trial. Br J Anaesth. 2023 Aug;131(2):385-396. doi: 10.1016/j.bja.2023.05.001. Epub 2023 Jun 9.
- Wu J, Gao S, Zhang S, Yu Y, Liu S, Zhang Z, Mei W. Perioperative risk factors for recovery room delirium after elective non-cardiovascular surgery under general anaesthesia. Perioper Med (Lond). 2021 Feb 3;10(1):3. doi: 10.1186/s13741-020-00174-0.
- Gu WJ, Zhou JX, Ji RQ, Zhou LY, Wang CM. Incidence, risk factors, and consequences of emergence delirium after elective brain tumor resection. Surgeon. 2022 Oct;20(5):e214-e220. doi: 10.1016/j.surge.2021.09.005. Epub 2021 Nov 12.
- Tesfaye Mekonin G, Kelbesa Olika M, Birhanu Wedajo M, Tolasa Badada A, Dukessa Dubiwak A, Tageza Ilala T, Gebre MN. Prevalence of Emergence Delirium and Associated Factors among Older Patients Who Underwent Elective Surgery: A Multicenter Observational Study. Anesthesiol Res Pract. 2022 Sep 9;2022:2711310. doi: 10.1155/2022/2711310. eCollection 2022.
- Saravana-Bawan B, Warkentin LM, Rucker D, Carr F, Churchill TA, Khadaroo RG. Incidence and predictors of postoperative delirium in the older acute care surgery population: a prospective study. Can J Surg. 2019 Feb 1;62(1):33-38. doi: 10.1503/cjs.016817.
- Bao L, Liu T, Zhang Z, Pan Q, Wang L, Fan G, Li Z, Yin Y. The prediction of postoperative delirium with the preoperative bispectral index in older aged patients: a cohort study. Aging Clin Exp Res. 2023 Jul;35(7):1531-1539. doi: 10.1007/s40520-023-02408-9. Epub 2023 May 19.
- Liu XH, Zhang QF, Liu Y, Lu QW, Wu JH, Gao XH, Chen ZY. Risk factors associated with postoperative delirium in elderly patients undergoing hip surgery. Front Psychiatry. 2023 Oct 19;14:1288117. doi: 10.3389/fpsyt.2023.1288117. eCollection 2023.
- Ha A, Krasnow RE, Mossanen M, Nagle R, Hshieh TT, Rudolph JL, Chang SL. A contemporary population-based analysis of the incidence, cost, and outcomes of postoperative delirium following major urologic cancer surgeries. Urol Oncol. 2018 Jul;36(7):341.e15-341.e22. doi: 10.1016/j.urolonc.2018.04.012. Epub 2018 May 24.
- Park EA, Kim MY. Postoperative Delirium is Associated with Negative Outcomes and Long-Term Mortality in Elderly Koreans: A Retrospective Observational Study. Medicina (Kaunas). 2019 Sep 20;55(10):618. doi: 10.3390/medicina55100618.
- Oberai T, Woodman R, Laver K, Crotty M, Kerkhoffs G, Jaarsma R. Is delirium associated with negative outcomes in older patients with hip fracture: analysis of the 4904 patients 2017-2018 from the Australian and New Zealand hip fracture registry. ANZ J Surg. 2022 Jan;92(1-2):200-205. doi: 10.1111/ans.17421. Epub 2021 Dec 13.
- Ma X, Chu H, Han K, Shao Q, Yu Y, Jia S, Wang D, Wang Z, Zhou Y. Postoperative delirium after transcatheter aortic valve replacement: An updated systematic review and meta-analysis. J Am Geriatr Soc. 2023 Feb;71(2):646-660. doi: 10.1111/jgs.18104. Epub 2022 Nov 23.
- Shi Z, Mei X, Li C, Chen Y, Zheng H, Wu Y, Zheng H, Liu L, Marcantonio ER, Xie Z, Shen Y. Postoperative Delirium Is Associated with Long-term Decline in Activities of Daily Living. Anesthesiology. 2019 Sep;131(3):492-500. doi: 10.1097/ALN.0000000000002849.
- Moskowitz EE, Overbey DM, Jones TS, Jones EL, Arcomano TR, Moore JT, Robinson TN. Post-operative delirium is associated with increased 5-year mortality. Am J Surg. 2017 Dec;214(6):1036-1038. doi: 10.1016/j.amjsurg.2017.08.034. Epub 2017 Sep 20.
- Yokoyama C, Yoshitnai K, Ogata S, Fukushima S, Matsuda H. Effect of postoperative delirium after cardiovascular surgery on 5-year mortality. JA Clin Rep. 2023 Oct 13;9(1):66. doi: 10.1186/s40981-023-00658-0.
- Niu JY, Yang N, Tao QY, He Y, Hou YB, Ning RD, Yu JM. Effect of Different Administration Routes of Dexmedetomidine on Postoperative Delirium in Elderly Patients Undergoing Elective Spinal Surgery: A Prospective Randomized Double-Blinded Controlled Trial. Anesth Analg. 2023 Jun 1;136(6):1075-1083. doi: 10.1213/ANE.0000000000006464. Epub 2023 Apr 14.
- Ghazaly HF, Hemaida TS, Zaher ZZ, Elkhodary OM, Hammad SS. A pre-anesthetic bolus of ketamine versus dexmedetomidine for prevention of postoperative delirium in elderly patients undergoing emergency surgery: a randomized, double-blinded, placebo-controlled study. BMC Anesthesiol. 2023 Dec 11;23(1):407. doi: 10.1186/s12871-023-02367-8.
- Li S, Li R, Li M, Cui Q, Zhang X, Ma T, Wang D, Zeng M, Li H, Bao Z, Peng Y, Sessler DI. Dexmedetomidine administration during brain tumour resection for prevention of postoperative delirium: a randomised trial. Br J Anaesth. 2023 Feb;130(2):e307-e316. doi: 10.1016/j.bja.2022.10.041. Epub 2022 Dec 13.
- He J, Zhang X, Li C, Fu B, Huang Y, Li H. Dexmedetomidine nasal administration improves perioperative sleep quality and neurocognitive deficits in elderly patients undergoing general anesthesia. BMC Anesthesiol. 2024 Jan 30;24(1):42. doi: 10.1186/s12871-024-02417-9.
- Pfenninger EG, Durieux ME, Himmelseher S. Cognitive impairment after small-dose ketamine isomers in comparison to equianalgesic racemic ketamine in human volunteers. Anesthesiology. 2002 Feb;96(2):357-66. doi: 10.1097/00000542-200202000-00022.
- Xu J, Jian J, Zhang Y, Wu J, Qiu Y. The efficacy of nasal administration of esketamine in patients having moderate-to-severe pain after preoperative CT-guided needle localization: a randomized, double-blind, placebo-controlled trial. Front Med (Lausanne). 2024 Apr 9;11:1344160. doi: 10.3389/fmed.2024.1344160. eCollection 2024.
- He M, Zhu Z, Jiang M, Liu X, Wu R, Zhou J, Chen X, Liu C. Risk Factors for Postanesthetic Emergence Delirium in Adults: A Systematic Review and Meta-analysis. J Neurosurg Anesthesiol. 2024 Jul 1;36(3):190-200. doi: 10.1097/ANA.0000000000000942. Epub 2023 Nov 2.
- Sica R, Wilson JM, Kim EJ, Culley DJ, Meints SM, Schreiber KL. The Relationship of Postoperative Pain and Opioid Consumption to Postoperative Delirium After Spine Surgery. J Pain Res. 2023 Jan 28;16:287-294. doi: 10.2147/JPR.S380616. eCollection 2023.
- Xing F, Zhang TT, Yang Z, Qu M, Shi X, Li Y, Li Y, Zhang W, Wang Z, Xing N. Comparison of dexmedetomidine and a dexmedetomidine-esketamine combination for reducing dental anxiety in preschool children undergoing dental treatment under general anesthesia: A randomized controlled trial. J Affect Disord. 2024 Feb 15;347:569-575. doi: 10.1016/j.jad.2023.12.011. Epub 2023 Dec 6.
- Goldberg TE, Chen C, Wang Y, Jung E, Swanson A, Ing C, Garcia PS, Whittington RA, Moitra V. Association of Delirium With Long-term Cognitive Decline: A Meta-analysis. JAMA Neurol. 2020 Nov 1;77(11):1373-1381. doi: 10.1001/jamaneurol.2020.2273.
- Li A, Yuen VM, Goulay-Dufay S, Sheng Y, Standing JF, Kwok PCL, Leung MKM, Leung AS, Wong ICK, Irwin MG. Pharmacokinetic and pharmacodynamic study of intranasal and intravenous dexmedetomidine. Br J Anaesth. 2018 May;120(5):960-968. doi: 10.1016/j.bja.2017.11.100. Epub 2018 Feb 2.
- Aldecoa C, Bettelli G, Bilotta F, Sanders RD, Audisio R, Borozdina A, Cherubini A, Jones C, Kehlet H, MacLullich A, Radtke F, Riese F, Slooter AJ, Veyckemans F, Kramer S, Neuner B, Weiss B, Spies CD. European Society of Anaesthesiology evidence-based and consensus-based guideline on postoperative delirium. Eur J Anaesthesiol. 2017 Apr;34(4):192-214. doi: 10.1097/EJA.0000000000000594.
- Hesse S, Kreuzer M, Hight D, Gaskell A, Devari P, Singh D, Taylor NB, Whalin MK, Lee S, Sleigh JW, Garcia PS. Association of electroencephalogram trajectories during emergence from anaesthesia with delirium in the postanaesthesia care unit: an early sign of postoperative complications. Br J Anaesth. 2019 May;122(5):622-634. doi: 10.1016/j.bja.2018.09.016. Epub 2018 Oct 25.
- Tawab Saljuqi A, Hanna K, Asmar S, Tang A, Zeeshan M, Gries L, Ditillo M, Kulvatunyou N, Castanon L, Joseph B. Prospective Evaluation of Delirium in Geriatric Patients Undergoing Emergency General Surgery. J Am Coll Surg. 2020 May;230(5):758-765. doi: 10.1016/j.jamcollsurg.2020.01.029. Epub 2020 Feb 21.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 2024-405
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.