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Clinical study on the application of Esketamine in perioperative period of puerpera: a randomized controlled trial

Clinical study on the application of Esketamine in perioperative period of puerpera: a randomized controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052668
Enrollment
Unknown
Registered
2021-11-03
Start date
2021-11-01
Completion date
Unknown
Last updated
2022-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perioperative and postoperative analgesic effect of puerpera

Interventions

Control group:10ml normal saline was injected intravenously after delivery
Experimental group1:0.15mg/kg of esketamine which was diluted to 10ml was injected intravenously after delivery
Experimental group2:0.25mg/kg of esketamine which was diluted to 10ml was injected intravenously after delivery

Sponsors

The Fourth Hospital of Shijiazhuang
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. ASA class II; 2. Before starting the activities related to the trial, voluntarily sign the informed consent form and fully understand the purpose and significance of this trial, and voluntarily abide by this trial procedure; 3. Subjects who plan to elective cesarean section under continuous spinal-epidural anesthesia; 4. Aged 18 to 40 years; 5. The estimated duration of surgery is less than or equal to 2 hours; 6. Post-pregnancy and prenatal body mass index (BMI) < 35kg/m2.

Exclusion criteria

Exclusion criteria: 1. There are contraindications to continuous spinal-epidural anesthesia (such as history of central nervous system infection, spinal cord or spinal canal disease or history of surgery, systemic infection, skin or soft tissue infection at puncture site, coagulation disorders); 2. Those with a history of stroke, cognitive impairment and epilepsy; 3. Those who have a history of myocardial infarction, angina pectoris, or a history of serious arrhythmia such as second-degree or higher atrioventricular block within 6 months before screening; 4. Pregnancy complicated with other diseases (malignant tumor, gestational hypertension, abnormal thyroid function, etc.); 5. In the non-oxygen state, the peripheral blood oxygen saturation (SpO2) is less than 92%; 6. Continuous use of sedatives, analgesics and hypnotics for 3 months before randomization.

Design outcomes

Primary

MeasureTime frame
Patient Health Questionnaire-9 score;Heart rate;Ramsay sedation score;Edinburgh Postpartum Depression Scale score;

Countries

China

Contacts

Public ContactChen Hongzhuan

The Fourth Hospital of Shijiazhuang

chenjunfeng123@yeah.net+86 15132110900

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026