Skip to content

Effect of epidural Esketamine on postoperative sleep quality in parturients after cesarean surgery

Effect of epidural Esketamine on postoperative sleep quality in parturients after cesarean surgery

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080989
Enrollment
Unknown
Registered
2024-02-20
Start date
2024-03-01
Completion date
Unknown
Last updated
2024-02-26

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

Conditions

Sleep disorder

Interventions

Esketamine group:During the surgery, 8ml of mixed solution (formula: 7.5mg/ml ropivacaine+0.5 mg/mL of Esketamine) was injected into the Epidural. After the surgery, an epidural analgesia pump was adm
Control group :During the surgery, 8ml of mixed solution (formula: 7.5mg/ml ropivacaine+the same volume of 0.9% normal saline) was injected into the Epidural. After the surgery, an epidural analgesia

Sponsors

Women's Hospital School of Medicine Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 45 Years

Inclusion criteria

Inclusion criteria: Full-term pregnancy aged 20-45 years old, ASA II Level; Planned elective cesarean surgery under epidural anesthesia; Sign an informed consent form.

Exclusion criteria

Exclusion criteria: Having a clear history of mental illness (depression, schizophrenia, etc.) or sleep disorders (such as insomnia, sleep apnea, etc.) before pregnancy, or taking analgesics, sedatives, antidepressants, etc;Cognitive or communication impairment; Preoperative having serious pregnancy complications (such as severe preeclampsia, placental implantation, HELLP syndrome, placenta previa, placental abruption), combined with severe organ dysfunction or endocrine disorders in the heart, liver, and kidneys, or ASA = III level; Contraindications of Esketamine (such as hypertension, tachycardia, allergies to Esketamine and its components, etc.); Patients refused to participate in the study.

Design outcomes

Primary

MeasureTime frame
Incidence of sleep disorders on the third day after postpartum;

Secondary

MeasureTime frame
NRS sleep score on the 7th day after cesarean surgery;NRS sleep score on the 14th day after cesarean surgery;PSQI score 42 days after surgery;ISI score 42 days after surgery;SAS score 42 days after surgery;EPDS score 42 days after surgery;Postpartum breastfeeding start time;Postpartum hospitalization days;Apgar scores at 1 minutes;Apgar scores at 5 minutes;Apgar scores at 10 minutes;Adverse reactions of 72 hours after surgery;

Countries

China

Contacts

Public ContactLili Xu

Women's Hospital School of Medicine Zhejiang University

xulili@zju.edu.cn+86 182 6814 4502

Outcome results

None listed

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