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

NCT04850937 | Completed

• 1 other identifier: ES
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

Esketamine; Depression; pain; leptin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• pain score

  Change from Baseline score at 3 months

• The serum leptin level

  Change from 1 day before surgery to 90 days after surgery

Study Arms (2)

Group S

EXPERIMENTAL

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

Drug: Esketamine

Group C

PLACEBO COMPARATOR

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

Drug: normal saline

Interventions

Esketamine DRUG

The experimental group will be given 0.25mg/kg esketamine slowly intravenously after anesthesia induction

Group S

normal saline DRUG

The experimental group will be given 0.5ml/kg normal saline intravenously after anesthesia induction

Group C

Eligibility Criteria

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

You may qualify if:

• (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.

You may not qualify if:

• (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;

Sponsors & Collaborators

• Yangzhou University: lead

Study Sites (1)

Affiliated hospital of yangzhou university

Yangzhou, Jiangsu, 225100, China

Location

MeSH Terms

Conditions

Depression; Pain

Interventions

Esketamine; Saline Solution

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• LIU M YU

  Yangzhou University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Anesthesiology, Yangzhou University Affiliated Hospital

Model Details: 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.

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 20, 2021
• Study Start: February 10, 2021
• Primary Completion: April 10, 2021
• Study Completion: May 10, 2022
• Last Updated: July 28, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)