Effect of Low-dose Esketamine on Postoperative Depression in Patients With Breast Cancer

Not Applicable

Completed

• Conditions: Depression
• Interventions: Drug: normal saline; Drug: Esketamine

• Registration Number: NCT04850937
• Lead Sponsor: Yangzhou University

Brief Summary

esketamine is an optical isomer of ketamine. Compared with ketamine, esketamine has the characteristics of higher effective value, stronger receptor affinity, less adverse reactions of nervous system, and pharmacokinetics is controllable.

Domestic and foreign studies have focused on the therapeutic effect of esketamine on major depression, but less attention has been paid to perioperative depression.This study intends to explore the effect of small doses of esketamine on patients with breast cancer.Postoperative depression and pain are observed.

Detailed Description

This study intends to explore the effect of small doses of esketamine on patients with breast cancer.WE pay attention to :

1. Safety of low-dose single intravenous injection of esketamine (1)The influence of intraoperative vital signs of patients after medication, such as blood pressure and heart rate fluctuation; (2)the duration of recovery after anesthesia; (3)postoperative adverse reactions, such as nausea and vomiting, dizziness and diplopia, respiratory depression, laryngeal spasm, delirium agitation, etc

2. Effect of single intravenous injection of low-dose ketamine on postoperative depression in patients undergoing radical mastectomy (1) 1 day before surgery, 2 days, 5 days, 30 days, 90 days after surgery Hamilton Depression Scale scores; (2) The serum leptin level 1 day before surgery, 2 days after surgery and 5 days after surgery; (3) Correlation between depression scale score and leptin level

3. Effects of low dose esketamine on acute and chronic pain in patients undergoing radical mastectomy

* visual analogue scale scores at 6, 12 and 24 hours after surgery;

* visual analogue scale scores at 3, 5, 30 and 90 days after surgery;

* the number of analgesic remedies

Study Timeline

• Study Start: 2021-02-10
• Primary Completion: 2021-04-10
• Study First Submitted: 2021-04-14
• Study First Submitted QC: 2021-04-19
• Study First Posted: 2021-04-20
• Study Completion: 2022-05-10
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-27
• Last Update Posted: 2022-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

• (1) Female patients who planned to undergo unilateral modified radical mastectomy in breast surgery; (2)Years of education ≥5 years,American Society of Anesthesiologists Ⅰ-II grade; (3) All patients undergoing surgery within 1 week after diagnosis of breast cancer, and do not receive preoperative radiotherapy or chemotherapy; (4) All the patients were married and had children, and were mainly cared for by their immediate family members after surgery.

Exclusion Criteria

• (1) Antidepressant treatment was received within the last 2 months; (2) previous personality disorder, intellectual retardation, brain injury or brain disease, combined with schizophrenia, mania and other mental diseases; (3) Preoperative patients with hyperthyroidism or hypothyroidism, severe cardiovascular disease, diabetes, severe blood deficiency, and abnormal heart, lung, liver, and kidney functions; (4) with diseases of the immune system, or use drugs that have obvious effects on the immune system; (5) Pregnancy or lactation;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C	normal saline	The control group will receive the same amount of normal saline after anesthesia induction
Group S	Esketamine	The experimental group will be given 0.25mg/kg esketamine slowly intravenously after anesthesia induction During administration, blood pressure and heart rate were observed.

Primary Outcome Measures

Name	Time	Method
depression score	Change from Baseline score at 3 months	The total rough score is the sum of all the scores in the 20 items, and then the rough score is multiplied by 1.25 to take the round part to get the standard score.; An SDS score of 53 to 62 is classified as mild depression, 63 to 72 as moderate depression, and 73 or more as major depression.

Secondary Outcome Measures

Name	Time	Method
The serum leptin level	Change from 1 day before surgery to 90 days after surgery	The serum leptin level 1 day before surgery, 2 days ,5 days 30 days and 90 days after surgery
pain score	Change from Baseline score at 3 months	visual analogue scale 0 points painless; 1 to 3 points for mild pain; 4 to 6 points moderate pain; Severe pain on a 7-9 scale; 10 points severe pain.

Trial Locations

Locations (1)

Affiliated hospital of yangzhou university; 🇨🇳 Yangzhou, Jiangsu, China