Effects of Esketamine on Postpartum Depression

Postpartum Depression Clinical Trial

— EEPD  

Official title:

Effects of Different Concentrations of Esketamine on Postpartum Depression After Cesarean Section

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05229913
• Other study ID #: JMYang
• Secondary ID: 2019-ZJ-930
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: February 20, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: January 2022
• Source: Qinghai University
• Contact: Wang Xuejun, director
• Phone: +86 18997159111
• Email: wangxuejunhsz9111[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: June 30, 2023
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 35 Years

Eligibility

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 ?+

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

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Postpartum Depression

Intervention

Drug:
• Esketamine is not added
Postoperative intravenous analgesia pump formula:Sufentanil 1ug/kg+ Flurbiprofen Axetil 200mg
• Esketamine 0.2mg/kg
Postoperative intravenous analgesia pump formula:Esketamine 0.2mg/kg + Sufentanil 1ug/kg+ Flurbiprofen Axetil 200mg.
• Esketamine 0.4mg/kg
Postoperative intravenous analgesia pump formula:Esketamine 0.4mg/kg + Sufentanil 1ug/kg+ Flurbiprofen Axetil 200ml.
• Esketamine 0.6mg/kg
Postoperative intravenous analgesia pump formula:Esketamine 0.6mg/kg + Sufentanil 1ug/kg+ Flurbiprofen Axetil 200mg.
• Esketamine 0.8mg/kg
Postoperative intravenous analgesia pump formula:Esketamine 0.8mg/kg + Sufentanil 1ug/kg+ Flurbiprofen Axetil 200mg.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Qinghai University	Qinghai Red Cross Hospital

References & Publications (4)

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. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The occurrence of adverse reactions	Include hallucinations, vomiting, dizziness, and drowsiness	Within 48 hours after surgery
Primary	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	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	6hours(T0), 12hours (T1), 24hours (T2), 48hours (T3) after operation
Secondary	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	6hours (T0), 12hours(T1), 24hours (T2), 48hours (T3) after operation