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

doi:10.2147/IJGM.S421265

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

Int J Gen Med. 2023 Aug 8:16:3373-3381. doi: 10.2147/IJGM.S421265. eCollection 2023.

Authors

Lin-Lin Liu^#^{1

2}, Jing-Hui Hu^#^{1

2}, Jing-Jing Pan^#^{1

3}, Hong Liu⁴, Fu-Hai Ji^{1

2}, Ke Peng^{1

2}

Affiliations

¹ Departments of Anesthesiology, First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, People's Republic of China.
² Institute of Anesthesiology, Soochow University, Suzhou, Jiangsu, People's Republic of China.
³ Department of Anesthesiology, Guanyun People's Hospital, Lianyungang, Jiangsu, People's Republic of China.
⁴ Department of Anesthesiology and Pain Medicine, University of California Davis Health, Sacramento, CA, USA.

^# Contributed equally.

Abstract

Background: 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.

Methods: 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.

Discussion: 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.

Trial registration: Chinese Clinical Trial Registry (ChiCTR2200064348).

Keywords: breast cancer; depressive symptoms; esketamine; modified radical mastectomy; perimenopausal women.

Grants and funding

This work is supported by the Suzhou Medical Health Science and Technology Innovation Project (SKY2022136 to KP), Jiangsu Medical Association Anesthesia Research Project (SYH-32021-0036 (2021031) to KP), College Students’ Extracurricular Academic Research Project of Soochow University (KY2023101A to JHH), National Natural Science Foundation of China (82072130 to FHJ), Key Medical Research Projects in Jiangsu Province (ZD2022021 to FHJ), and Suzhou Clinical Medical Center for Anesthesiology (Szlcyxzxj202102 to FHJ). The funders have no role in study design, management, data collection, analysis, data interpretation, writing of the report, or the decision to submit the report for publication.