search
Back to results

Effects of Esketamine on Postpartum Depression (EEPD)

Primary Purpose

Postpartum Depression

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Esketamine is not added
Esketamine 0.2mg/kg
Esketamine 0.4mg/kg
Esketamine 0.6mg/kg
Esketamine 0.8mg/kg
Sponsored by
Qinghai University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum Depression focused on measuring Esketamine, Postpartum Depression

Eligibility Criteria

25 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. All participating patients signed an informed consent form;
  2. Age 25-35 years old;
  3. BMI≤35kg/m2;
  4. ASA classification I or II;
  5. Ultrasound showed a single pregnancy in the uterus Fetus, placental maturity grade Ⅱ+

Exclusion Criteria:

  1. Unable or unwilling to sign the consent form, or unable to follow the research procedures;
  2. History of thyroid disease;
  3. A history of local anesthetic allergy;
  4. A history of addiction or abuse to opioids and ketamine;
  5. Preoperative mental illness; severe eclampsia;
  6. Abnormal ECG, hypertension and severe heart Medical history
  7. There are other contraindications to the use of esketamine

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Placebo Comparator

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    The control group (Esketamine is not added)

    Esketamine experimental group(E0.2)

    Esketamine experimental group (E0.4)

    Esketamine experimental group (E0.6)

    Esketamine experimental group (E0.8)

    Arm Description

    Postoperative intravenous analgesia pump formula:Sufentanil 1ug/kg+ Flurbiprofen Axetil 200mg The intravenous analgesic pump in each group was supplemented with normal saline and matched to 100 ml, the background infusion rate is 2ml/h, the Self-controlled intravenous analgesia pressing once dose is 1ml, the locking time is 20min, and the analgesia lasted until 48h after surgery.

    Postoperative intravenous analgesia pump formula:Esketamine 0.2mg/kg + Sufentanil 1ug/kg+ Flurbiprofen Axetil 200mg The intravenous analgesic pump in each group was supplemented with normal saline and matched to 100 ml, the background infusion rate is 2ml/h, the Self-controlled intravenous analgesia pressing once dose is 1ml, the locking time is 20min, and the analgesia lasted until 48h after surgery.

    Postoperative intravenous analgesia pump formula:Esketamine 0.4mg/kg + Sufentanil 1ug/kg+ Flurbiprofen Axetil 200mg The intravenous analgesic pump in each group was supplemented with normal saline and matched to 100 ml, the background infusion rate is 2ml/h, the Self-controlled intravenous analgesia pressing once dose is 1ml, the locking time is 20min, and the analgesia lasted until 48h after surgery.

    Postoperative intravenous analgesia pump formula:Esketamine 0.6mg/kg + Sufentanil 1ug/kg+ Flurbiprofen Axetil 200mg The intravenous analgesic pump in each group was supplemented with normal saline and matched to 100 ml, the background infusion rate is 2ml/h, the Self-controlled intravenous analgesia pressing once dose is 1ml, the locking time is 20min, and the analgesia lasted until 48h after surgery.

    Postoperative intravenous analgesia pump formula:Esketamine 0.8mg/kg + Sufentanil 1ug/kg+ Flurbiprofen Axetil 200mg The intravenous analgesic pump in each group was supplemented with normal saline and matched to 100 ml, the background infusion rate is 2ml/h, the Self-controlled intravenous analgesia pressing once dose is 1ml, the locking time is 20min, and the analgesia lasted until 48h after surgery.

    Outcomes

    Primary Outcome Measures

    Edinburgh Postpartum Depression Scale (EPDS) score
    The Edinburgh Postpartum Depression Scale includes 10 items. According to the severity of symptoms, each item is divided into 4 levels (0, 1, 2, 3). The patient may be depressed when the total score is 10-12 points, and postpartum depression can be diagnosed when the total score is greater than 13 points.

    Secondary Outcome Measures

    short-form of McGill Pain Questionnaire (SF-MPQ)
    The SF-MPQ consisted of 11 sensory and 4 affective descriptors for pain. All descriptors are used 0~3 to indicate the different degrees of none, light, medium and heavy respectively
    Visual analog scale (VAS) for pain
    Patients were asked to circle a number that best represented their pain level using a scale of 0-10, with 0 being no pain and 10 being most severe. 0: painless; 1-3: Mild pain; 4-6: Moderate pain; 7-10: Severe pain

    Full Information

    First Posted
    January 5, 2022
    Last Updated
    January 27, 2022
    Sponsor
    Qinghai University
    Collaborators
    Qinghai Red Cross Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05229913
    Brief Title
    Effects of Esketamine on Postpartum Depression
    Acronym
    EEPD
    Official Title
    Effects of Different Concentrations of Esketamine on Postpartum Depression After Cesarean Section
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 20, 2022 (Anticipated)
    Primary Completion Date
    September 30, 2022 (Anticipated)
    Study Completion Date
    June 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Qinghai University
    Collaborators
    Qinghai Red Cross Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    Different concentrations of Esketamine were used after cesarean section. Through the evaluation of postoperative psychological status and analgesic effect, the optimal dosage of Esketamine to exert the effects of depression and analgesia was analyzed.
    Detailed Description
    A total of 500 cases of pregnant women undergoing cesarean section under spinal anesthesia in Qinghai Red Cross Hospital from February 2022 to September 2022 were selected. General information of the patients were recorded, such as age, height, weight, BMI, nationality, education level, previous history, surgical history, allergy history, spouse status, fertility history and drug use status, and ASA classification was performed. Preliminarily determine whether it meets the inclusion and exclusion criteria. If it can be included in the study, the purpose, method and possible complications of the study should be fully explained to the patients and their families, as well as the significance and value of the study. Informed consent should be signed after the informed consent of the patients and their families. Patients were divided into 5 groups (n=100) according to random number method, including control group (GROUP C) and different concentrations of Esketamine dose group (group E0.2, group E0.4, group E0.6, group E0.8). Before surgery, the puerpera were fasted for 8 hours and abstained from drinking for 4 hours. After entering the operating room, ECG monitoring and continuous oxygen inhalation by mask (2.0-3.0 L/min) were performed, and the upper limb vein channels were opened. Subarachnoid puncture was performed in L2-3 or L3-4 gaps. After the cerebrospinal fluid flows out, give 0.5% ropivacaine 10-12mg. After the subarachnoid block was successful, the epidural catheter was indurated for 4cm. The supine position was restored, and when necessary, the pregnant women were changed 30° to the left, and the supine hypotension syndrome occurred (SBP≤90mmHg or decrease ≥mmHg), 1-2mg methoxide was injected intravenously. The operation was started after the level of anesthesia was satisfied (maintain anesthesia level<T6). Postoperative intravenous controlled analgesia (PCIA). The formula of PCIA in different groups.The unified total amount of PCIA is 100mL, the background infusion rate is 2mL /h, the PCA dose is 1ml, the locking time is 20min, and the analgesia lasted until 48h after surgery. Using SPSS26.0 statistical software. The measurement data is expressed as x±s, the comparison between groups is performed by one-way analysis of variance, the further pairwise comparison is performed by t test, and the comparison of different time points within the group is performed by repeated measures analysis of variance; the comparison of count data is performed by the chi-square test. P<0.05 indicates that the difference is statistically significant.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postpartum Depression
    Keywords
    Esketamine, Postpartum Depression

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Sequential Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    500 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    The control group (Esketamine is not added)
    Arm Type
    Placebo Comparator
    Arm Description
    Postoperative intravenous analgesia pump formula:Sufentanil 1ug/kg+ Flurbiprofen Axetil 200mg The intravenous analgesic pump in each group was supplemented with normal saline and matched to 100 ml, the background infusion rate is 2ml/h, the Self-controlled intravenous analgesia pressing once dose is 1ml, the locking time is 20min, and the analgesia lasted until 48h after surgery.
    Arm Title
    Esketamine experimental group(E0.2)
    Arm Type
    Experimental
    Arm Description
    Postoperative intravenous analgesia pump formula:Esketamine 0.2mg/kg + Sufentanil 1ug/kg+ Flurbiprofen Axetil 200mg The intravenous analgesic pump in each group was supplemented with normal saline and matched to 100 ml, the background infusion rate is 2ml/h, the Self-controlled intravenous analgesia pressing once dose is 1ml, the locking time is 20min, and the analgesia lasted until 48h after surgery.
    Arm Title
    Esketamine experimental group (E0.4)
    Arm Type
    Experimental
    Arm Description
    Postoperative intravenous analgesia pump formula:Esketamine 0.4mg/kg + Sufentanil 1ug/kg+ Flurbiprofen Axetil 200mg The intravenous analgesic pump in each group was supplemented with normal saline and matched to 100 ml, the background infusion rate is 2ml/h, the Self-controlled intravenous analgesia pressing once dose is 1ml, the locking time is 20min, and the analgesia lasted until 48h after surgery.
    Arm Title
    Esketamine experimental group (E0.6)
    Arm Type
    Experimental
    Arm Description
    Postoperative intravenous analgesia pump formula:Esketamine 0.6mg/kg + Sufentanil 1ug/kg+ Flurbiprofen Axetil 200mg The intravenous analgesic pump in each group was supplemented with normal saline and matched to 100 ml, the background infusion rate is 2ml/h, the Self-controlled intravenous analgesia pressing once dose is 1ml, the locking time is 20min, and the analgesia lasted until 48h after surgery.
    Arm Title
    Esketamine experimental group (E0.8)
    Arm Type
    Experimental
    Arm Description
    Postoperative intravenous analgesia pump formula:Esketamine 0.8mg/kg + Sufentanil 1ug/kg+ Flurbiprofen Axetil 200mg The intravenous analgesic pump in each group was supplemented with normal saline and matched to 100 ml, the background infusion rate is 2ml/h, the Self-controlled intravenous analgesia pressing once dose is 1ml, the locking time is 20min, and the analgesia lasted until 48h after surgery.
    Intervention Type
    Drug
    Intervention Name(s)
    Esketamine is not added
    Intervention Description
    Postoperative intravenous analgesia pump formula:Sufentanil 1ug/kg+ Flurbiprofen Axetil 200mg
    Intervention Type
    Drug
    Intervention Name(s)
    Esketamine 0.2mg/kg
    Intervention Description
    Postoperative intravenous analgesia pump formula:Esketamine 0.2mg/kg + Sufentanil 1ug/kg+ Flurbiprofen Axetil 200mg.
    Intervention Type
    Drug
    Intervention Name(s)
    Esketamine 0.4mg/kg
    Intervention Description
    Postoperative intravenous analgesia pump formula:Esketamine 0.4mg/kg + Sufentanil 1ug/kg+ Flurbiprofen Axetil 200ml.
    Intervention Type
    Drug
    Intervention Name(s)
    Esketamine 0.6mg/kg
    Intervention Description
    Postoperative intravenous analgesia pump formula:Esketamine 0.6mg/kg + Sufentanil 1ug/kg+ Flurbiprofen Axetil 200mg.
    Intervention Type
    Drug
    Intervention Name(s)
    Esketamine 0.8mg/kg
    Intervention Description
    Postoperative intravenous analgesia pump formula:Esketamine 0.8mg/kg + Sufentanil 1ug/kg+ Flurbiprofen Axetil 200mg.
    Primary Outcome Measure Information:
    Title
    Edinburgh Postpartum Depression Scale (EPDS) score
    Description
    The Edinburgh Postpartum Depression Scale includes 10 items. According to the severity of symptoms, each item is divided into 4 levels (0, 1, 2, 3). The patient may be depressed when the total score is 10-12 points, and postpartum depression can be diagnosed when the total score is greater than 13 points.
    Time Frame
    The Edinburgh Postpartum Depression Scale (EPDS) score was performed day 42 after surgery
    Secondary Outcome Measure Information:
    Title
    short-form of McGill Pain Questionnaire (SF-MPQ)
    Description
    The SF-MPQ consisted of 11 sensory and 4 affective descriptors for pain. All descriptors are used 0~3 to indicate the different degrees of none, light, medium and heavy respectively
    Time Frame
    6hours(T0), 12hours (T1), 24hours (T2), 48hours (T3) after operation
    Title
    Visual analog scale (VAS) for pain
    Description
    Patients were asked to circle a number that best represented their pain level using a scale of 0-10, with 0 being no pain and 10 being most severe. 0: painless; 1-3: Mild pain; 4-6: Moderate pain; 7-10: Severe pain
    Time Frame
    6hours (T0), 12hours(T1), 24hours (T2), 48hours (T3) after operation
    Other Pre-specified Outcome Measures:
    Title
    The occurrence of adverse reactions
    Description
    Include hallucinations, vomiting, dizziness, and drowsiness
    Time Frame
    Within 48 hours after surgery

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: All participating patients signed an informed consent form; Age 25-35 years old; BMI≤35kg/m2; ASA classification I or II; Ultrasound showed a single pregnancy in the uterus Fetus, placental maturity grade Ⅱ+ Exclusion Criteria: Unable or unwilling to sign the consent form, or unable to follow the research procedures; History of thyroid disease; A history of local anesthetic allergy; A history of addiction or abuse to opioids and ketamine; Preoperative mental illness; severe eclampsia; Abnormal ECG, hypertension and severe heart Medical history There are other contraindications to the use of esketamine
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Wang Xuejun, director
    Phone
    +86 18997159111
    Email
    wangxuejunhsz9111@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yang Jingmei, Master
    Phone
    +86 18091336383
    Email
    yangjingmei0119@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wang Xuejun, director
    Organizational Affiliation
    Department of Anesthesiology, Qinghai Red Cross Hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Participants' basic information, depression and analgesia scores after esketamine use, and incidence of adverse reactions were shared
    IPD Sharing Time Frame
    As of December 2025
    IPD Sharing Access Criteria
    All the people
    Citations:
    PubMed Identifier
    22374377
    Citation
    Suppa E, Valente A, Catarci S, Zanfini BA, Draisci G. A study of low-dose S-ketamine infusion as "preventive" pain treatment for cesarean section with spinal anesthesia: benefits and side effects. Minerva Anestesiol. 2012 Jul;78(7):774-81. Epub 2012 Feb 29.
    Results Reference
    background
    PubMed Identifier
    32243798
    Citation
    Krystal JH, Charney DS, Duman RS. A New Rapid-Acting Antidepressant. Cell. 2020 Apr 2;181(1):7. doi: 10.1016/j.cell.2020.02.033.
    Results Reference
    background
    PubMed Identifier
    26707087
    Citation
    Singh JB, Fedgchin M, Daly E, Xi L, Melman C, De Bruecker G, Tadic A, Sienaert P, Wiegand F, Manji H, Drevets WC, Van Nueten L. Intravenous Esketamine in Adult Treatment-Resistant Depression: A Double-Blind, Double-Randomization, Placebo-Controlled Study. Biol Psychiatry. 2016 Sep 15;80(6):424-431. doi: 10.1016/j.biopsych.2015.10.018. Epub 2015 Nov 3.
    Results Reference
    background
    PubMed Identifier
    23394227
    Citation
    O'Hara MW, McCabe JE. Postpartum depression: current status and future directions. Annu Rev Clin Psychol. 2013;9:379-407. doi: 10.1146/annurev-clinpsy-050212-185612. Epub 2013 Feb 1.
    Results Reference
    result

    Learn more about this trial

    Effects of Esketamine on Postpartum Depression

    We'll reach out to this number within 24 hrs