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

Sponsor

Yangzhou University (Other)

Overall Status

Completed

CT.gov ID

NCT04850937

Collaborator

(none)

Enrollment

Location

Arms

14.9

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depression	Drug: Esketamine Drug: normal saline	N/A

Detailed Description

This study intends to explore the effect of small doses of esketamine on patients with breast cancer.WE pay attention to :

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
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
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 Design

Study Type:

Interventional

Actual Enrollment :

90 participants

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.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

Official Title:

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

Actual Study Start Date :

Feb 10, 2021

Actual Primary Completion Date :

Apr 10, 2021

Actual Study Completion Date :

May 10, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: Esketamine The experimental group will be given 0.25mg/kg esketamine slowly intravenously after anesthesia induction
Placebo Comparator: Group C The control group will receive the same amount of normal saline after anesthesia induction	Drug: normal saline The experimental group will be given 0.5ml/kg normal saline intravenously after anesthesia induction

Arm

Intervention/Treatment

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.

Drug: Esketamine

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

Placebo Comparator: Group C

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

Drug: normal saline

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

Outcome Measures

Primary Outcome Measures

depression score [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.

Secondary Outcome Measures

pain score [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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;