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

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ClinicalTrials.gov Identifier: NCT04850937
Recruitment Status : Recruiting
First Posted : April 20, 2021
Last Update Posted : April 20, 2021
Sponsor:
Information provided by (Responsible Party):
Ma Hong, Yangzhou University

Tracking Information
First Submitted Date  ICMJE April 14, 2021
First Posted Date  ICMJE April 20, 2021
Last Update Posted Date April 20, 2021
Actual Study Start Date  ICMJE February 10, 2021
Actual Primary Completion Date April 10, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2021)
depression score [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2021)
  • pain score [ Time Frame: 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.
  • The serum leptin level [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Low-dose Esketamine on Postoperative Depression in Patients With Breast Cancer
Official Title  ICMJE Effect of Low-dose Esketamine on Postoperative Depression in Patients With Breast Cancer
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
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.
Masking: Double (Participant, Investigator)
Masking Description:

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.

Primary Purpose: Prevention
Condition  ICMJE Depression
Intervention  ICMJE
  • Drug: Esketamine
    The experimental group will be given 0.25mg/kg esketamine slowly intravenously after anesthesia induction
  • Drug: normal saline
    The experimental group will be given 0.5ml/kg normal saline intravenously after anesthesia induction
Study Arms  ICMJE
  • Experimental: Group S
    The experimental group will be given 0.25mg/kg esketamine slowly intravenously after anesthesia induction During administration, blood pressure and heart rate were observed.
    Intervention: Drug: Esketamine
  • Placebo Comparator: Group C
    The control group will receive the same amount of normal saline after anesthesia induction
    Intervention: Drug: normal saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 19, 2021)
180
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 10, 2022
Actual Primary Completion Date April 10, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: MA HONG 13675161040 mahongyzdaxue@163.com
Contact: LIU M YU 17625860820 myliu@yzu.edu.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04850937
Other Study ID Numbers  ICMJE ES
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ma Hong, Yangzhou University
Study Sponsor  ICMJE Yangzhou University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: LIU M YU Yangzhou University
PRS Account Yangzhou University
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP