An Intraoperative Sub-Anesthetic Dose of Esketamine on Postoperative Depressive Symptoms in Perimenopausal Women with Breast Cancer Undergoing Modified Radical Mastectomy: Protocol for a Randomized, Triple-Blinded, Controlled Trial.
Lin-Lin Liu, Jing-Hui Hu, Jing-Jing Pan, Hong Liu, Fu-Hai Ji, Ke Peng
International journal of general medicine 2023 DOI: 10.2147/ijgm.s421265 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial (protocol) Placebo-controlled Peer reviewed |
|---|---|
| Sample size | 130 |
| Population | Perimenopausal women aged 45-60 years with breast cancer undergoing unilateral modified radical mastectomy |
| Intervention | Esketamine |
| Dose | 0.25 mg/kg i.v. |
| Duration | Follow-up to day 180 postoperatively |
| Measures | Beck's Depression Inventory (BDI) |
| Topics | Esketamine |
| Keywords | Breast cancer Depressive symptoms Modified radical mastectomy Perimenopausal women |
| Key findings | The protocol proposes that a single intraoperative sub-anesthetic dose of esketamine (0.25 mg/kg) may reduce the incidence of postoperative depressive symptoms in perimenopausal women after modified radical mastectomy, compared with placebo. The trial is designed to test this hypothesis, with depressive symptoms at day 30 (Beck's Depression Inventory) as the primary outcome; no results are yet available. |
Abstract
Depressive symptoms are common among perimenopausal women with breast cancer having modified radical mastectomy. Esketamine exerts antidepressant effects. This study aims to assess whether an intraoperative sub-anesthetic dose of esketamine prevents postoperative depressive symptoms in these patients. In this randomized, triple-blinded, placebo-controlled trial, we will enroll 130 perimenopausal women (aged 45-60 years) with breast cancer undergoing unilateral modified radical mastectomy. Patients will be randomly assigned with a 1:1 ratio to receive either esketamine (0.25 mg/kg i.v.) or normal saline after anesthesia induction and before skin incision. The primary outcome is the incidence of depressive symptoms at day 30 postoperatively, assessed using the Beck's Depression Inventory (BDI). Secondary outcomes include incidence of depressive symptoms and BDI scores at day 1, 3, and 180 postoperatively, anxiety symptoms and scores at day 1, 3, 30, and 180 postoperatively, pain intensity and quality of recovery at day 1 and 2 postoperatively, nausea and vomiting within 48 hours postoperatively, length of postoperative hospital stay, and cancer-specific outcomes. Data will be analyzed in the modified intention-to-treat population. This is the first trial to evaluate the effects of a sub-anesthetic dose of esketamine on depressive symptoms in perimenopausal women after modified radical mastectomy. The results of this study will help to improve their mental health and recovery after breast cancer surgery. Chinese Clinical Trial Registry (ChiCTR2200064348).
Comparable studies
Other randomized controlled trials on esketamine, most cited first.
Citations in the library
Cited by 4
- Esketamine in depression: putative biomarkers from clinical research. European Archives of Psychiatry and Clinical Neuroscience July 13, 2024
- Esketamine reduces postoperative depression in breast cancer through TREK-1 channel inhibition and neurotransmitter modulation. Cancer cell international February 18, 2025
- The psychoactive effects of repeated ketamine infusions and their mechanistic role in the treatment of alcohol use disorder: Secondary analysis of a randomised controlled trial Addiction February 16, 2026
- Effects of Continuous Perioperative Esketamine Infusion on Postoperative Depression in Breast Cancer Patients: A Randomized Controlled Double-Blind Trial. Drug Design, Development and Therapy October 29, 2025
Cites 12
- mTOR-Dependent Synapse Formation Underlies the Rapid Antidepressant Effects of NMDA Antagonists Science August 19, 2010
- Synthesizing the Evidence for Ketamine and Esketamine in Treatment-Resistant Depression: An International Expert Opinion on the Available Evidence and Implementation American Journal of Psychiatry March 17, 2021
- BDNF Release Is Required for the Behavioral Actions of Ketamine The International Journal of Neuropsychopharmacology October 31, 2014
- Efficacy and safety of adjunctive therapy using esketamine or racemic ketamine for adult treatment-resistant depression: A randomized, double-blind, non-inferiority study. Journal of Affective Disorders November 14, 2019
- Maintenance ketamine treatment for depression: a systematic review of efficacy, safety, and tolerability. The Lancet Psychiatry November 1, 2022
and 7 more in the library