drugset / Trial / NCT07308756
Impact of Perioperative Dexmedetomidine and Esketamine on Postoperative Quality of Recovery
RandomizedFactorialQuadruple-blindPrevention
Summary
For patients after surgery, quality of recovery has significant impacts on the prognosis, quality of life, and rational allocation of medical resources. Dexmedetomidine and esketamine have each been used during the perioperative period and improved postoperative analgesia and subjective sleep quality. This 2x2 factorial trial is designed to explore the effects of dexmedetomidine, esketamine, and their combination on the quality of recovery in patients recovering from surgery under general anesthesia.
Timeline
- Start
- 2026-01-05
- Primary completion
- 2027-03
- Completion
- 2027-04
Publications
- Background 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.
- Background Guo J, Qiu D, Gu HW, Wang XM, Hashimoto K, Zhang GF, Yang JJ. Efficacy and safety of perioperative application of ketamine on postoperative depression: A meta-analysis of randomized controlled studies. Mol Psychiatry. 2023 Jun;28(6):2266-2276. doi: 10.1038/s41380-023-01945-z. Epub 2023 Jan 20.
- Background Xie M, Liang Y, Deng Y, Li T. Effect of S-ketamine on Postoperative Pain in Adults Post-Abdominal Surgery: A Systematic Review and Meta-analysis. Pain Physician. 2023 Jul;26(4):327-335.
- Background Wang S, Deng CM, Zeng Y, Chen XZ, Li AY, Feng SW, Xu LL, Chen L, Yuan HM, Hu H, Yang T, Han T, Zhang HY, Jiang M, Sun XY, Guo HN, Sessler DI, Wang DX. Efficacy of a single low dose of esketamine after childbirth for mothers with symptoms of prenatal depression: randomised clinical trial. BMJ. 2024 Apr 10;385:e078218. doi: 10.1136/bmj-2023-078218.
- Background Persson J, Hasselstrom J, Maurset A, Oye I, Svensson JO, Almqvist O, Scheinin H, Gustafsson LL, Almqvist O. Pharmacokinetics and non-analgesic effects of S- and R-ketamines in healthy volunteers with normal and reduced metabolic capacity. Eur J Clin Pharmacol. 2002 Feb;57(12):869-75. doi: 10.1007/s002280100353.
- Background Segmiller F, Ruther T, Linhardt A, Padberg F, Berger M, Pogarell O, Moller HJ, Kohler C, Schule C. Repeated S-ketamine infusions in therapy resistant depression: a case series. J Clin Pharmacol. 2013 Sep;53(9):996-8. doi: 10.1002/jcph.122. Epub 2013 Jul 24. No abstract available.
- Background Canuso CM, Singh JB, Fedgchin M, Alphs L, Lane R, Lim P, Pinter C, Hough D, Sanacora G, Manji H, Drevets WC. Efficacy and Safety of Intranasal Esketamine for the Rapid Reduction of Symptoms of Depression and Suicidality in Patients at Imminent Risk for Suicide: Results of a Double-Blind, Randomized, Placebo-Controlled Study. Focus (Am Psychiatr Publ). 2019 Jan;17(1):55-65. doi: 10.1176/appi.focus.17105. Epub 2019 Jan 7.
- Background 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.
- Background Bartova L, Papageorgiou K, Milenkovic I, Dold M, Weidenauer A, Willeit M, Winkler D, Kasper S. Rapid antidepressant effect of S-ketamine in schizophrenia. Eur Neuropsychopharmacol. 2018 Aug;28(8):980-982. doi: 10.1016/j.euroneuro.2018.05.007. Epub 2018 Jul 2.
- Background Smith-Apeldoorn SY, Veraart JK, Spijker J, Kamphuis J, Schoevers RA. Maintenance ketamine treatment for depression: a systematic review of efficacy, safety, and tolerability. Lancet Psychiatry. 2022 Nov;9(11):907-921. doi: 10.1016/S2215-0366(22)00317-0.
- Background Ma S, Chen M, Jiang Y, Xiang X, Wang S, Wu Z, Li S, Cui Y, Wang J, Zhu Y, Zhang Y, Ma H, Duan S, Li H, Yang Y, Lingle CJ, Hu H. Sustained antidepressant effect of ketamine through NMDAR trapping in the LHb. Nature. 2023 Oct;622(7984):802-809. doi: 10.1038/s41586-023-06624-1. Epub 2023 Oct 18.
- Background Brinck EC, Tiippana E, Heesen M, Bell RF, Straube S, Moore RA, Kontinen V. Perioperative intravenous ketamine for acute postoperative pain in adults. Cochrane Database Syst Rev. 2018 Dec 20;12(12):CD012033. doi: 10.1002/14651858.CD012033.pub4.
- Background Schnabel A, Meyer-Friessem CH, Reichl SU, Zahn PK, Pogatzki-Zahn EM. Is intraoperative dexmedetomidine a new option for postoperative pain treatment? A meta-analysis of randomized controlled trials. Pain. 2013 Jul;154(7):1140-9. doi: 10.1016/j.pain.2013.03.029. Epub 2013 Mar 27.
- Background Wu XH, Cui F, Zhang C, Meng ZT, Wang DX, Ma J, Wang GF, Zhu SN, Ma D. Low-dose Dexmedetomidine Improves Sleep Quality Pattern in Elderly Patients after Noncardiac Surgery in the Intensive Care Unit: A Pilot Randomized Controlled Trial. Anesthesiology. 2016 Nov;125(5):979-991. doi: 10.1097/ALN.0000000000001325.
- Background Lu W, Fu Q, Luo X, Fu S, Hu K. Effects of dexmedetomidine on sleep quality of patients after surgery without mechanical ventilation in ICU. Medicine (Baltimore). 2017 Jun;96(23):e7081. doi: 10.1097/MD.0000000000007081.
- Background Huupponen E, Maksimow A, Lapinlampi P, Sarkela M, Saastamoinen A, Snapir A, Scheinin H, Scheinin M, Merilainen P, Himanen SL, Jaaskelainen S. Electroencephalogram spindle activity during dexmedetomidine sedation and physiological sleep. Acta Anaesthesiol Scand. 2008 Feb;52(2):289-94. doi: 10.1111/j.1399-6576.2007.01537.x. Epub 2007 Nov 14.
- Background Tasbihgou SR, Barends CRM, Absalom AR. The role of dexmedetomidine in neurosurgery. Best Pract Res Clin Anaesthesiol. 2021 Jul;35(2):221-229. doi: 10.1016/j.bpa.2020.10.002. Epub 2020 Oct 14.
- Background Mo Y, Zimmermann AE. Role of dexmedetomidine for the prevention and treatment of delirium in intensive care unit patients. Ann Pharmacother. 2013 Jun;47(6):869-76. doi: 10.1345/aph.1AR708.
- Background Xu M, Zhang G, Tang Y, Wang R, Yang J. Impact of Regional Anesthesia on Subjective Quality of Recovery in Patients Undergoing Thoracic Surgery: A Systematic Review and Meta-Analysis. J Cardiothorac Vasc Anesth. 2023 Sep;37(9):1744-1750. doi: 10.1053/j.jvca.2023.05.003. Epub 2023 May 5.
- Background Joe YE, Kang CM, Lee HM, Kim KJ, Hwang HK, Lee JR. Quality of Recovery of Patients Who Underwent Curative Pancreatectomy: Comparison of Total Intravenous Anesthesia Versus Inhalation Anesthesia Using the QOR-40 Questionnaire. World J Surg. 2021 Aug;45(8):2581-2590. doi: 10.1007/s00268-021-06117-0. Epub 2021 Apr 21.
- Background Hung KC, Ko CC, Hsu CW, Pang YL, Chen JY, Sun CK. Association of peripheral nerve blocks with patient-reported quality of recovery in female patients receiving breast cancer surgery: a systematic review and meta-analysis of randomized controlled studies. Can J Anaesth. 2022 Oct;69(10):1288-1299. doi: 10.1007/s12630-022-02295-0. Epub 2022 Jul 26.
- Background Hung KC, Chu CC, Hsing CH, Chang YP, Li YY, Liu WC, Chen IW, Chen JY, Sun CK. Association between perioperative intravenous lidocaine and subjective quality of recovery: A meta-analysis of randomized controlled trials. J Clin Anesth. 2021 Dec;75:110521. doi: 10.1016/j.jclinane.2021.110521. Epub 2021 Sep 20.
- Background Nilsson U, Gruen R, Myles PS. Postoperative recovery: the importance of the team. Anaesthesia. 2020 Jan;75 Suppl 1:e158-e164. doi: 10.1111/anae.14869.
- Background Campfort M, Cayla C, Lasocki S, Rineau E, Leger M. Early quality of recovery according to QoR-15 score is associated with one-month postoperative complications after elective surgery. J Clin Anesth. 2022 Jun;78:110638. doi: 10.1016/j.jclinane.2021.110638. Epub 2022 Jan 13.
- Background Shulman MA, Myles PS, Chan MT, McIlroy DR, Wallace S, Ponsford J. Measurement of disability-free survival after surgery. Anesthesiology. 2015 Mar;122(3):524-36. doi: 10.1097/ALN.0000000000000586.
- Background Tahiri M, Sikder T, Maimon G, Teasdale D, Hamadani F, Sourial N, Feldman LS, Guralnick J, Fraser SA, Demyttenaere S, Bergman S. The impact of postoperative complications on the recovery of elderly surgical patients. Surg Endosc. 2016 May;30(5):1762-70. doi: 10.1007/s00464-015-4440-2. Epub 2015 Jul 21.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexmedetomidine | Other / unclassified | 0.2 ug/kg | — |
| Subject | Esketamine | Other / unclassified | 0.1 mg/kg | — |
Indications
No indication recorded.