Effect of Subanesthetic Dose of Esketamine on Sleep Quality

NCT06773143 | Recruiting DMC

• 2 other identifiers: KY20240514-05-KS-01ZKX21038
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Insomnia; Breast Cancer Surgery; Esketamine

Outcome Measures

Primary Outcomes (1)

• The incidence of PSD on postoperative day -1

  On the first day after surgery, NRS ≥ 6 or AIS ≥ 6.PSD is defined as a numeric rating scale (NRS) ≥6 or Athens Insomnia Scale (AIS) ≥6, indicating that sleep is repeatedly disturbed or worse throughout the night. NRS scores range from 0 to 10, with 0 representing excellent or good sleep and 10 representing inability to sleep all night. AIS consists of 8 items: nighttime awakenings, sleep induction, final awakening, total sleep time, sleep quality, well-being, functional ability, and daytime sleepiness.

  the first day after surgery

Secondary Outcomes (11)

• static Visual Analog Scale score on postoperative day -2

  on postoperative day -2

• dynamic Visual Analog Scale score on postoperative day -2

  on postoperative day -2

• anxiety and depression score on the day before surgery

  the day before surgery

• The incidence of PSD on postoperative day -3

  he third day after surgery

• The incidence of PSD on postoperative day -5

  On the fifth day after surgery

Other Outcomes (3)

• IL-6 blood on the day before surgery

  the day before surgery

• TNFα on the day before surgery

  the day before surgery

• BDNF on the day before surgery

  the day before surgery

Study Arms (2)

esketamine group

EXPERIMENTAL

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.

Drug: Esketamine at low dose

control group

PLACEBO COMPARATOR

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.

Other: Normal Saline (0.9% NaCl)

Interventions

Esketamine at low dose DRUG

After the induction of general anesthesia, patients in the esketamine group will receive a continuous infusion of esketamine (0.3 mg/kg/h) until the end of the operation.

esketamine group

Normal Saline (0.9% NaCl) OTHER

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.

control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with breast cancer by pathology and immunohistochemistry
• Patients receiving neoadjuvant chemotherapy
• Age 18 to 65 years old; d) ;
• ASA grade Ⅰ - Ⅲ
• BMI 18 to 30 kg/m2

You may not qualify if:

• : Patients refuse to participate in the study
• : BMI \> 30 kg/m2
• : Recent history of drug abuse
• : Allergy to or contraindications to esketamine
• : Cognitive dysfunction or inability to communicate
• : Severe dysfunction of important organs such as liver and kidney function

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

RECRUITING

Related Publications (10)

• 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.

  PMID: 14982564 BACKGROUND

• 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.

  PMID: 33189715 BACKGROUND

• 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.

  PMID: 34992482 BACKGROUND

• 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.

  PMID: 34970147 BACKGROUND

• 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.

  PMID: 33387333 BACKGROUND

• 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.

  PMID: 33022440 BACKGROUND

• 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.

  PMID: 23982301 BACKGROUND

• 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.

  PMID: 32733363 BACKGROUND

• 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.

  PMID: 36454569 BACKGROUND

• 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.

  PMID: 24650832 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• xiaoliang wang

  The First Affiliated Hospital with Nanjing Medical University

  STUDY DIRECTOR

Central Study Contacts

wenwen zhang, Dr

CONTACT

+8615366110306; 1395626955@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 1, 2025
• First Posted: January 14, 2025
• Study Start: December 30, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)