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

NCT ID: NCT04850937

Last Updated: 2022-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-10
• Study Completion Date: 2022-05-10

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

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Esketamine

Intervention Type: DRUG

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

Group C

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

Group Type: PLACEBO_COMPARATOR

normal saline

Intervention Type: DRUG

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

Interventions

Esketamine

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

Intervention Type: DRUG

normal saline

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

Intervention Type: DRUG

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Yangzhou University

OTHER

Sponsor Role: lead

Responsible Party

Ma Hong

Department of Anesthesiology, Yangzhou University Affiliated Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

LIU M YU

Role: PRINCIPAL_INVESTIGATOR

Yangzhou University

Locations

Affiliated hospital of yangzhou university

Yangzhou, Jiangsu, China

Countries

China

Other Identifiers

ES

Identifier Type: -

Identifier Source: org_study_id