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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04850937
Other study ID # ES
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 10, 2021
Est. completion date May 10, 2022

Study information

Verified date July 2022
Source Yangzhou University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date May 10, 2022
Est. primary completion date April 10, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility 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 ?-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


Related Conditions & MeSH terms


Intervention

Drug:
Esketamine
The experimental group will be given 0.25mg/kg esketamine slowly intravenously after anesthesia induction
normal saline
The experimental group will be given 0.5ml/kg normal saline intravenously after anesthesia induction

Locations

Country Name City State
China Affiliated hospital of yangzhou university Yangzhou Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Yangzhou University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary depression score 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.
Change from Baseline score at 3 months
Secondary pain score 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.
Change from Baseline score at 3 months
Secondary The serum leptin level The serum leptin level 1 day before surgery, 2 days ,5 days 30 days and 90 days after surgery Change from 1 day before surgery to 90 days after surgery
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