Effects of Esketamine on Postpartum Depression

NCT05229913 | Unknown Phase 4

• 2 other identifiers: JMYang2019-ZJ-930
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postpartum Depression

Keywords

Esketamine; Postpartum Depression

Outcome Measures

Primary Outcomes (1)

• 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.

  The Edinburgh Postpartum Depression Scale (EPDS) score was performed day 42 after surgery

Secondary Outcomes (2)

• short-form of McGill Pain Questionnaire (SF-MPQ)

  6hours(T0), 12hours (T1), 24hours (T2), 48hours (T3) after operation

• Visual analog scale (VAS) for pain

  6hours (T0), 12hours(T1), 24hours (T2), 48hours (T3) after operation

Other Outcomes (1)

• The occurrence of adverse reactions

  Within 48 hours after surgery

Study Arms (5)

The control group （Esketamine is not added）

PLACEBO COMPARATOR

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.

Drug: Esketamine is not added

Esketamine experimental group(E0.2)

EXPERIMENTAL

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.

Drug: Esketamine 0.2mg/kg

Esketamine experimental group (E0.4)

EXPERIMENTAL

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.

Drug: Esketamine 0.4mg/kg

Esketamine experimental group (E0.6)

EXPERIMENTAL

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.

Drug: Esketamine 0.6mg/kg

Esketamine experimental group (E0.8)

EXPERIMENTAL

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.

Drug: Esketamine 0.8mg/kg

Interventions

Esketamine is not added DRUG

Postoperative intravenous analgesia pump formula：Sufentanil 1ug/kg+ Flurbiprofen Axetil 200mg

The control group （Esketamine is not added）

Esketamine 0.2mg/kg DRUG

Postoperative intravenous analgesia pump formula：Esketamine 0.2mg/kg + Sufentanil 1ug/kg+ Flurbiprofen Axetil 200mg.

Esketamine experimental group(E0.2)

Esketamine 0.4mg/kg DRUG

Postoperative intravenous analgesia pump formula：Esketamine 0.4mg/kg + Sufentanil 1ug/kg+ Flurbiprofen Axetil 200ml.

Esketamine experimental group (E0.4)

Esketamine 0.6mg/kg DRUG

Postoperative intravenous analgesia pump formula：Esketamine 0.6mg/kg + Sufentanil 1ug/kg+ Flurbiprofen Axetil 200mg.

Esketamine experimental group (E0.6)

Esketamine 0.8mg/kg DRUG

Postoperative intravenous analgesia pump formula：Esketamine 0.8mg/kg + Sufentanil 1ug/kg+ Flurbiprofen Axetil 200mg.

Esketamine experimental group (E0.8)

Eligibility Criteria

• Age: 25 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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+

You may not qualify if:

• 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

Sponsors & Collaborators

• Qinghai University: lead
• Qinghai Red Cross Hospital: collaborator

Related Publications (4)

• 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.

  PMID: 22374377 BACKGROUND

• 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.

  PMID: 32243798 BACKGROUND

• 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.

  PMID: 26707087 BACKGROUND

• 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.

  PMID: 23394227 RESULT

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Esketamine

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Wang Xuejun, director

  Department of Anesthesiology, Qinghai Red Cross Hospital

  STUDY DIRECTOR

Central Study Contacts

Wang Xuejun, director

CONTACT

+86 18997159111; wangxuejunhsz9111@163.com

Yang Jingmei, Master

CONTACT

+86 18091336383; yangjingmei0119@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: February 8, 2022
• Study Start: February 20, 2022
• Primary Completion: September 30, 2022
• Study Completion: June 30, 2023
• Last Updated: February 8, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: As of December 2025
• Access Criteria: All the people