Effect of Subanesthetic Dose of Esketamine on Sleep Quality
Summary
The goal of this clinical trial is to explore whether subanesthetic doses of esketamine can improve the sleep quality of patients undergoing modified radical mastectomy for breast cancer. In this study, 184 people are expected to participate from admission to three days after surgery. The process requires participants to cooperate with the completion of the digital rating scale, the Athens Insomnia Scale, the Visual Analog Pain Rating Scale, the Hospital Anxiety and Depression Rating Scale, and the collection of venous blood for research indicators (IL-6, TNF-α, cor, BDNF). If participants agree to participate in this study, the investigators will assign a unique identification number to each participant and create a medical record for participants. One day before surgery, the investigators will conduct assessments using the Athens Insomnia Scale, the Visual Analog Pain Rating Scale, and the Hospital Anxiety and Depression Scale, and collect approximately 6 mL of venous blood. One day after surgery, the investigators will repeat the assessments using the Athens Insomnia Scale, the Visual Analog Pain Rating Scale, and the Hospital Anxiety and Depression Scale. Additionally, the investigators will collect another 6 mL of venous blood and monitor the use of analgesics. The investigators will follow up with participants three days after the surgery. During this follow-up, investigators will assess any sleep disturbances, administer the Hospital Anxiety and Depression Scale, and review the use of analgesics.
Timeline
- Start
- 2024-12-30
- Primary completion
- 2026-12-31
- Completion
- 2027-04-30
Publications
- Results Sun J, Wang XD, Liu H, Xu JG. Ketamine suppresses endotoxin-induced NF-kappaB activation and cytokines production in the intestine. Acta Anaesthesiol Scand. 2004 Mar;48(3):317-21. doi: 10.1111/j.0001-5172.2004.0312.x.
- Results Kohtala S, Alitalo O, Rosenholm M, Rozov S, Rantamaki T. Time is of the essence: Coupling sleep-wake and circadian neurobiology to the antidepressant effects of ketamine. Pharmacol Ther. 2021 May;221:107741. doi: 10.1016/j.pharmthera.2020.107741. Epub 2020 Nov 12.
- Results Song B, Zhu J. A Novel Application of Ketamine for Improving Perioperative Sleep Disturbances. Nat Sci Sleep. 2021 Dec 25;13:2251-2266. doi: 10.2147/NSS.S341161. eCollection 2021.
- Results Song B, Zhu JC. Mechanisms of the Rapid Effects of Ketamine on Depression and Sleep Disturbances: A Narrative Review. Front Pharmacol. 2021 Dec 14;12:782457. doi: 10.3389/fphar.2021.782457. eCollection 2021.
- Results Wang M, Zhang B, Zhou Y, Wang C, Zheng W, Liu W, Zhan Y, Lan X, Ning Y. Sleep improvement is associated with the antidepressant efficacy of repeated-dose ketamine and serum BDNF levels: a post-hoc analysis. Pharmacol Rep. 2021 Apr;73(2):594-603. doi: 10.1007/s43440-020-00203-1. Epub 2021 Jan 2.
- Results Bahji A, Vazquez GH, Zarate CA Jr. Comparative efficacy of racemic ketamine and esketamine for depression: A systematic review and meta-analysis. J Affect Disord. 2021 Jan 1;278:542-555. doi: 10.1016/j.jad.2020.09.071. Epub 2020 Sep 23.
- Results Murrough JW, Iosifescu DV, Chang LC, Al Jurdi RK, Green CE, Perez AM, Iqbal S, Pillemer S, Foulkes A, Shah A, Charney DS, Mathew SJ. Antidepressant efficacy of ketamine in treatment-resistant major depression: a two-site randomized controlled trial. Am J Psychiatry. 2013 Oct;170(10):1134-42. doi: 10.1176/appi.ajp.2013.13030392.
- Results Luo M, Song B, Zhu J. Sleep Disturbances After General Anesthesia: Current Perspectives. Front Neurol. 2020 Jul 8;11:629. doi: 10.3389/fneur.2020.00629. eCollection 2020.
- Results Qiu D, Wang XM, Yang JJ, Chen S, Yue CB, Hashimoto K, Yang JJ. Effect of Intraoperative Esketamine Infusion on Postoperative Sleep Disturbance After Gynecological Laparoscopy: A Randomized Clinical Trial. JAMA Netw Open. 2022 Dec 1;5(12):e2244514. doi: 10.1001/jamanetworkopen.2022.44514.
- Results Matthews EE, Berger AM, Schmiege SJ, Cook PF, McCarthy MS, Moore CM, Aloia MS. Cognitive behavioral therapy for insomnia outcomes in women after primary breast cancer treatment: a randomized, controlled trial. Oncol Nurs Forum. 2014 May;41(3):241-53. doi: 10.1188/14.ONF.41-03AP.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Esketamine | Other / unclassified | 0.3 mg/kg | Intravenous |