Perinatal psychiatric disorders
Conditions
Interventions
Experimental group V:Vitamin C (iv gtt) after fetal delivery
Control group C:Normal saline (iv gtt) after fetal delivery
Experimental group VK1:Vitamin C (iv gtt) after fetal delivery, and a sub-effective dose of esketamine is pumped intravenously over 40 minutes after fetal delivery
Experimental group VK2:Vitamin C (iv gtt) after fetal delivery, and a conventionally effective dose of esketamine is pumped intravenously over 40 minutes after fetal delivery
Control group K:A conventionally effective dose of esketamine is pumped intravenously over 40 minutes after fetal delivery
Experimental group V0K0:Normal saline (iv gtt) after fetal delivery, and normal saline is pumped intravenously over 40 minutes after fetal delivery
Experimental group V0K1:Normal saline (iv gtt) after fetal delivery, and a sub-effective dose of esketamine is pumped intravenously over 40 minutes after fetal delivery
Experimental group V0K2:Normal saline (iv gtt) after fetal delivery, and an effective dose of esketamine is pumped intravenously over 40 minutes after fetal delivery
Experimental group V1K0:Vitamin C (iv gtt) after fetal delivery, and normal saline is pumped intravenously over 40 minutes after fetal delivery
Experimental group V1K1:Vitamin C (iv gtt) after fetal delivery, and a sub-effective dose of esketamine is pumped intravenously over 40 minutes after fetal delivery
Experimental group V1K2:Vitamin C (iv gtt) after fetal delivery, and an effective dose of esketamine is pumped intravenously over 40 minutes after fetal delivery
Sponsors
The First Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 35 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-35 years, ASA class I-II, and body mass index (BMI) of 18.5-30 kg/m2; 2. Able to communicate well with the follow-up investigator and being will to participate; 3. Primiparous women with full-term singleton pregnancies who underwent cesarean section under intrathecal anesthesia.
Exclusion criteria
Exclusion criteria: 1. ASA classification= level 3; 2. Abnormal electrocardiogram; 3. Hypertension and/or severe heart disease; 4. Neuropsychiatric disease, dysfunction or poor compliance; 5. Allergy to esketamine and/or ascorbic acid; 6. History of ketamine/esketamine abuse or dependence; 7. Ineffective or serious adverse events in previous (es) ketamine medication; 8. Other drug or alcohol dependence; 9. Contraindications to neuraxial anesthesia; 10. Insufficient literacy level such as reading and writing; 11. Refusal of written informed consent; 12. Previous participation in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PPD incidence assessed with Edinburgh Postnatal Depression Scale (EPDS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Edinburgh Postnatal Depression Scale (EPDS) depression scale score;Numerical rating scale for pain assessing;Self-Rating Anxiety Scale;Athens Insomnia Scale;Postoperative self-controlled analgesic pump use (number of compressions, total amount of medication, rescue medication, etc.);Blood Vitamin C levels;Blood interleukin-6 (IL-6) levels;Blood brain-derived neurotrophic factor (BDNF) levels;Infant health status (1 month after birth);Patient satisfaction;Adverse effects;Blood IL-1ß levels;Blood TNF-a levels;Blood CRP levels; | — |
Countries
China
Contacts
Public ContactJie Luo
The First Affiliated Hospital of Chongqing Medical University
Outcome results
None listed