Effects of Esketamine on Postpartum Depression (EEPD)

Qinghai University

Status and phase: Unknown; Phase 4

Conditions: Postpartum Depression

Treatments: Drug: Esketamine 0.6mg/kg; Drug: Esketamine 0.8mg/kg; Drug: Esketamine 0.2mg/kg; Drug: Esketamine 0.4mg/kg; Drug: Esketamine is not added

Study type: Interventional

Funder types: Other

Identifiers

NCT05229913

JMYang

2019-ZJ-930 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: Female

Ages: 25 to 35 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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500 participants in 5 patient groups, including a placebo group

The control group （Esketamine is not added）

Placebo Comparator group

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.

Treatment:

Drug: Esketamine is not added

Esketamine experimental group(E0.2)

Experimental group

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.

Treatment:

Drug: Esketamine 0.2mg/kg

Esketamine experimental group (E0.4)

Experimental group

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.

Treatment:

Drug: Esketamine 0.4mg/kg

Esketamine experimental group (E0.6)

Experimental group

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.

Treatment:

Drug: Esketamine 0.6mg/kg

Esketamine experimental group (E0.8)

Experimental group

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.

Treatment:

Drug: Esketamine 0.8mg/kg