Clinical trial · Interventional
Effect of Subanesthetic Dose of Esketamine on Sleep Quality
Effect of Subanesthetic Dose of Esketamine on Sleep Quality in Patients With Breast Cancer After Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Surgery | — | UNRESOLVED | — |
| Esketamine | — | UNRESOLVED | — |
| Insomnia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Esketamine at low dose | Drug | — | UNRESOLVED |
| Normal Saline (0.9% NaCl) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- esketamine group
- description
- After the patient is induced with general anesthesia, esketamine (0.3 mg/kg/h) will be continuously infused during the operation until the end of the operation.
- interventionNames
- Drug: Esketamine at low dose
- type
- PLACEBO_COMPARATOR
- label
- control group
- description
- After the patient's general anesthesia induction is completed, normal saline will be continuously infused until the end of the operation, and the infusion volume is the same as that of the esketamine group.
- interventionNames
- Other: Normal Saline (0.9% NaCl)
Primary outcomes (1)
- measure
- The incidence of PSD on postoperative day -1
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients diagnosed with breast cancer by pathology and immunohistochemistry 2. Patients receiving neoadjuvant chemotherapy 3. Age 18 to 65 years old; d) ; 4. ASA grade Ⅰ - Ⅲ 5. BMI 18 to 30 kg/m2 Exclusion Criteria: * 1: Patients refuse to participate in the study 2: BMI \> 30 kg/m2 3: Recent history of drug abuse 4: Allergy to or contraindications to esketamine 5: Cognitive dysfunction or inability to communicate 6: Severe dysfunction of important organs such as liver and kidney function
References
Publications (10)
- RESULTSun 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. PMID 14982564
- RESULTKohtala 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. PMID 33189715
- RESULTSong 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. PMID 34992482
- RESULTSong 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. PMID 34970147
- RESULTWang 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. PMID 33387333
- RESULTBahji 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. PMID 33022440
- RESULTMurrough 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.