Effect of Low-dose Esketamine on Postoperative Depression in Patients With Breast Cancer
Primary Purpose
Depression
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Esketamine
normal saline
Sponsored by
About this trial
This is an interventional prevention trial for Depression focused on measuring Esketamine, Depression, pain, leptin
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;
Sites / Locations
- Affiliated hospital of yangzhou university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Group S
Group C
Arm Description
The experimental group will be given 0.25mg/kg esketamine slowly intravenously after anesthesia induction During administration, blood pressure and heart rate were observed.
The control group will receive the same amount of normal saline after anesthesia induction
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
The serum leptin level
The serum leptin level 1 day before surgery, 2 days ,5 days 30 days and 90 days after surgery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04850937
Brief Title
Effect of Low-dose Esketamine on Postoperative Depression in Patients With Breast Cancer
Official Title
Effect of Low-dose Esketamine on Postoperative Depression in Patients With Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
February 10, 2021 (Actual)
Primary Completion Date
April 10, 2021 (Actual)
Study Completion Date
May 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yangzhou University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Esketamine, Depression, pain, leptin
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigator
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.
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group S
Arm Type
Experimental
Arm Description
The experimental group will be given 0.25mg/kg esketamine slowly intravenously after anesthesia induction During administration, blood pressure and heart rate were observed.
Arm Title
Group C
Arm Type
Placebo Comparator
Arm Description
The control group will receive the same amount of normal saline after anesthesia induction
Intervention Type
Drug
Intervention Name(s)
Esketamine
Intervention Description
The experimental group will be given 0.25mg/kg esketamine slowly intravenously after anesthesia induction
Intervention Type
Drug
Intervention Name(s)
normal saline
Intervention Description
The experimental group will be given 0.5ml/kg normal saline intravenously after anesthesia induction
Primary Outcome Measure Information:
Title
depression score
Description
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.
Time Frame
Change from Baseline score at 3 months
Secondary Outcome Measure Information:
Title
pain score
Description
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.
Time Frame
Change from Baseline score at 3 months
Title
The serum leptin level
Description
The serum leptin level 1 day before surgery, 2 days ,5 days 30 days and 90 days after surgery
Time Frame
Change from 1 day before surgery to 90 days after surgery
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LIU M YU
Organizational Affiliation
Yangzhou University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Affiliated hospital of yangzhou university
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225100
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Low-dose Esketamine on Postoperative Depression in Patients With Breast Cancer
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