Clinical trial NCT05229913: Effects of Esketamine on Postpartum Depression
Official title: Effects of Different Concentrations of Esketamine on Postpartum Depression After Cesarean Section
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postpartum Depression
Keywords: Esketamine
Postpartum Depression
Lead sponsor: Qinghai University
Sponsor class: OTHER
Collaborators: name: Qinghai Red Cross Hospital
First posted: 2022-02-08
Enrollment: 500
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Edinburgh Postpartum Depression Scale (EPDS) score
timeFrame: The Edinburgh Postpartum Depression Scale (EPDS) score was performed day 42 after surgery
Secondary outcomes:
measure: short-form of McGill Pain Questionnaire (SF-MPQ)
timeFrame: 6hours(T0), 12hours (T1), 24hours (T2), 48hours (T3) after operation
measure: Visual analog scale (VAS) for pain
timeFrame: 6hours (T0), 12hours(T1), 24hours (T2), 48hours (T3) after operation
Other outcomes:
measure: The occurrence of adverse reactions
timeFrame: Within 48 hours after surgery
Locations:
Study officials:
affiliation: Department of Anesthesiology, Qinghai Red Cross Hospital
name: Wang Xuejun, director
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.