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

Ketamine

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.

Intervention / Treatment

180 patients will be divided into two groups according to the random number table method: control group (normal saline group),treatment group (esketamine group), 120 cases in each group.
  • Esketamine (DRUG)
    The experimental group will be given 0.25mg/kg esketamine slowly intravenously after anesthesia induction
  • Normal saline (DRUG)
    The experimental group will be given 0.5ml/kg normal saline intravenously after anesthesia induction

Condition or Disease

  • Depression

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 65 Years
    Enrollment: 90 (ACTUAL)
    Allocation: Randomized
    Primary Purpose: Prevention

    Masking

    Esketamine 10ml (5mg/ml) and normal saline 10ml were respectively set as drug A or drug B. Without the knowledge of the experimenter, the predetermined dose of drug A or B will be given to the experimenter before induction of anesthesia, with 0.05 mL /kg for each patient. After all samples are collected, the third party will announce the grouping and medication.

    DOUBLE:
    • Participant
    • Investigator

    Clinical Trial Dates

    Start date: Feb 10, 2021 ACTUAL
    Primary Completion: Apr 10, 2021 ACTUAL
    Completion Date: May 10, 2022 ACTUAL
    Study First Posted: Apr 20, 2021 ACTUAL
    Last Updated: Jul 27, 2022

    Sponsors / Collaborators

    Lead Sponsor: N/A
    Responsible Party: N/A

    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

    Participant Groups

    • The experimental group will be given 0.25mg/kg esketamine slowly intravenously after anesthesia induction During administration, blood pressure and heart rate were observed.

    • The control group will receive the same amount of normal saline after anesthesia induction

    Eligibility Criteria

    Sex: Female
    Minimum Age: 18
    Maximum Age: 65
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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;

    Primary Outcomes

    • 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 Outcomes

    • 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.

    • The serum leptin level 1 day before surgery, 2 days ,5 days 30 days and 90 days after surgery

    More Details

    NCT Number: NCT04850937
    Other IDs: ES
    Study URL: https://clinicaltrials.gov/study/NCT04850937
    Last updated: Sep 29, 2023