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STUDY PROTOCOL

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

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Pages 3373-3381 | Received 14 May 2023, Accepted 02 Aug 2023, Published online: 08 Aug 2023

References

  • Arnold M, Morgan E, Rumgay H, et al. Current and future burden of breast cancer: global statistics for 2020 and 2040. Breast. 2022;66:15–23. doi:10.1016/j.breast.2022.08.010
  • Carreira H, Williams R, Funston G, Stanway S, Bhaskaran K. Associations between breast cancer survivorship and adverse mental health outcomes: a matched population-based cohort study in the United Kingdom. PLoS Med. 2021;18(1):e1003504. doi:10.1371/journal.pmed.1003504
  • Kim SY, Kim SW, Shin IS, et al. Changes in depression status during the year after breast cancer surgery and impact on quality of life and functioning. Gen Hosp Psychiatry. 2018;50:33–37. doi:10.1016/j.genhosppsych.2017.09.009
  • Maass SW, Roorda C, Berendsen AJ, Verhaak PF, de Bock GH. The prevalence of long-term symptoms of depression and anxiety after breast cancer treatment: a systematic review. Maturitas. 2015;82(1):100–108. doi:10.1016/j.maturitas.2015.04.010
  • Tang R, Luo M, Li J, et al. Symptoms of anxiety and depression among Chinese women transitioning through menopause: findings from a prospective community-based cohort study. Fertil Steril. 2019;112(6):1160–1171. doi:10.1016/j.fertnstert.2019.08.005
  • Yang Y, Cui Y, Sang K, et al. Ketamine blocks bursting in the lateral habenula to rapidly relieve depression. Nature. 2018;554(7692):317–322. doi:10.1038/nature25509
  • 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;9(11):907–921. doi:10.1016/S2215-0366(22)00317-0
  • Hirota K, Lambert DG. Ketamine and depression. Br J Anaesth. 2018;121(6):1198–1202. doi:10.1016/j.bja.2018.08.020
  • Johnston JN, Henter ID, Zarate CA Jr. The antidepressant actions of ketamine and its enantiomers. Pharmacol Ther. 2023;246:108431. doi:10.1016/j.pharmthera.2023.108431
  • Kim J, Farchione T, Potter A, Chen Q, Temple R. Esketamine for treatment-resistant depression - first FDA-approved antidepressant in a new class. N Engl J Med. 2019;381(1):1–4. doi:10.1056/NEJMp1903305
  • McIntyre RS, Rosenblat JD, Nemeroff CB, et al. Synthesizing the evidence for ketamine and esketamine in treatment-resistant depression: an international expert opinion on the available evidence and implementation. Am J Psychiatry. 2021;178(5):383–399. doi:10.1176/appi.ajp.2020.20081251
  • Wang J, Wang Y, Xu X, Peng S, Xu F, Liu P. Use of various doses of S-ketamine in treatment of depression and pain in cervical carcinoma patients with mild/moderate depression after laparoscopic total hysterectomy. Med Sci Monit. 2020;26:e922028. doi:10.12659/MSM.922028
  • Guo J, Qiu D, Gu HW, et al. Efficacy and safety of perioperative application of ketamine on postoperative depression: a meta-analysis of randomized controlled studies. Mol Psychiatry. 2023. doi:10.1038/s41380-023-01945-z
  • Wang J, Sun Y, Ai P, et al. The effect of intravenous ketamine on depressive symptoms after surgery: a systematic review. J Clin Anesth. 2022;77:110631. doi:10.1016/j.jclinane.2021.110631
  • Gan SL, Long YQ, Wang QY, et al. Effect of esketamine on postoperative depressive symptoms in patients undergoing thoracoscopic lung cancer surgery: a randomized controlled trial. Front Psychiatry. 2023;14:1128406. doi:10.3389/fpsyt.2023.1128406
  • Calvert M, Kyte D, Mercieca-Bebber R, et al. Guidelines for inclusion of patient-reported outcomes in clinical trial protocols: the SPIRIT-PRO extension. JAMA. 2018;319(5):483–494. doi:10.1001/jama.2017.21903
  • Beck AT, Beamesderfer A. Assessment of depression: the depression inventory. Mod Probl Pharmacopsychiatry. 1974;7:151–169. doi:10.1159/000395074
  • Fan N, Xu K, Ning Y, et al. Profiling the psychotic, depressive and anxiety symptoms in chronic ketamine users. Psychiatry Res. 2016;237:311–315. doi:10.1016/j.psychres.2016.01.023
  • Zung WW. A rating instrument for anxiety disorders. Psychosomatics. 1971;12(6):371–379. doi:10.1016/S0033-3182(71)71479-0
  • Dunstan DA, Scott N. Norms for Zung’s Self-rating Anxiety Scale. BMC Psychiatry. 2020;20(1):90. doi:10.1186/s12888-019-2427-6
  • Geng Y, Gao T, Zhang X, Wang Y, Zhang Z. The association between disease duration and mood disorders in rheumatoid arthritis patients. Clin Rheumatol. 2022;41(3):661–668. doi:10.1007/s10067-021-05967-2
  • Genc C, Kaya C, Bilgin S, Dost B, Ustun YB, Koksal E. Pectoserratus plane block versus erector spinae plane block for postoperative opioid consumption and acute and chronic pain after breast cancer surgery: a randomized controlled trial. J Clin Anesth. 2022;79:110691. doi:10.1016/j.jclinane.2022.110691
  • Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013;118(6):1332–1340. doi:10.1097/ALN.0b013e318289b84b
  • Wessels E, Perrie H, Scribante J, Jooma Z. Quality of recovery in the perioperative setting: a narrative review. J Clin Anesth. 2022;78:110685. doi:10.1016/j.jclinane.2022.110685
  • Kleif J, Gogenur I. Severity classification of the quality of recovery-15 score-an observational study. J Surg Res. 2018;225:101–107. doi:10.1016/j.jss.2017.12.040
  • Tao Y, Yu H, Liu S, et al. Hope and depression: the mediating role of social support and spiritual coping in advanced cancer patients. BMC Psychiatry. 2022;22(1):345. doi:10.1186/s12888-022-03985-1
  • Moher D, Hopewell S, Schulz KF, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c869. doi:10.1136/bmj.c869
  • de Kruif M, Spijker AT, Molendijk ML. Depression during the perimenopause: a meta-analysis. J Affect Disord. 2016;206:174–180. doi:10.1016/j.jad.2016.07.040
  • Grub J, Suss H, Willi J, Ehlert U. Steroid hormone secretion over the course of the perimenopause: findings from the swiss perimenopause study. Front Glob Womens Health. 2021;2:774308. doi:10.3389/fgwh.2021.774308
  • Ren Q, Hua L, Zhou X, et al. Effects of a single sub-anesthetic dose of ketamine on postoperative emotional responses and inflammatory factors in colorectal cancer patients. Front Pharmacol. 2022;13:818822. doi:10.3389/fphar.2022.818822
  • Zhang Z, Zhang WH, Lu YX, et al. Intraoperative low-dose S-ketamine reduces depressive symptoms in patients with crohn’s disease undergoing bowel resection: a randomized controlled trial. J Clin Med. 2023;12(3):1152.
  • Liu P, Li P, Li Q, et al. Effect of pretreatment of S-ketamine on postoperative depression for breast cancer patients. J Invest Surg. 2021;34(8):883–888. doi:10.1080/08941939.2019.1710626
  • Correia-Melo FS, Leal GC, Vieira F, et al. Efficacy and safety of adjunctive therapy using esketamine or racemic ketamine for adult treatment-resistant depression: a randomized, double-blind, non-inferiority study. J Affect Disord. 2020;264:527–534. doi:10.1016/j.jad.2019.11.086
  • Gastaldon C, Raschi E, Kane JM, Barbui C, Schoretsanitis G. Post-marketing safety concerns with esketamine: a disproportionality analysis of spontaneous reports submitted to the FDA adverse event reporting system. Psychother Psychosom. 2021;90(1):41–48. doi:10.1159/000510703
  • Chen B, Dowlatshahi D, MacQueen GM, Wang JF, Young LT. Increased hippocampal BDNF immunoreactivity in subjects treated with antidepressant medication. Biol Psychiatry. 2001;50(4):260–265. doi:10.1016/s0006-3223(01)01083-6
  • Martinowich K, Manji H, Lu B. New insights into BDNF function in depression and anxiety. Nat Neurosci. 2007;10(9):1089–1093. doi:10.1038/nn1971
  • Medeiros GC, Gould TD, Prueitt WL, et al. Blood-based biomarkers of antidepressant response to ketamine and esketamine: a systematic review and meta-analysis. Mol Psychiatry. 2022;27(9):3658–3669. doi:10.1038/s41380-022-01652-1
  • Lepack AE, Fuchikami M, Dwyer JM, Banasr M, Duman RS. BDNF release is required for the behavioral actions of ketamine. Int J Neuropsychopharmacol. 2014;18(1):pyu033.
  • Li N, Lee B, Liu RJ, et al. mTOR-dependent synapse formation underlies the rapid antidepressant effects of NMDA antagonists. Science. 2010;329(5994):959–964. doi:10.1126/science.1190287
  • Carreira H, Williams R, Muller M, Harewood R, Stanway S, Bhaskaran K. Associations between breast cancer survivorship and adverse mental health outcomes: a systematic review. J Natl Cancer Inst. 2018;110(12):1311–1327. doi:10.1093/jnci/djy177