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Effect of epidural application of dexmedetomidine on sleep quality after cesarean section

Effect of epidural application of dexmedetomidine on sleep quality after cesarean section

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077592
Enrollment
Unknown
Registered
2023-11-14
Start date
2023-11-14
Completion date
Unknown
Last updated
2025-03-31

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

Conditions

Sleep-wake disorder

Interventions

Dexmedetomidine group:Intraoperative epidural injection of 8ml mixture (formula: 7.5mg / ml ropivacaine + dexmedetomidine 1ug / mL), postoperative epidural analgesia pump, containing a mixture of 100
Control group :Intraoperative epidural injection of 8 mL mixture (formula: 7.5 mg / ml ropivacaine + 0.9 % normal saline of the same volume), postoperative epidural analgesia pump, containing 100 mL m

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: 1. Pregnant women aged 20-45 years with full-term pregnancy; 2. Elective cesarean section under epidural anesthesia; 3. Signed informed consent.

Exclusion criteria

Exclusion criteria: 1. There is a clear history of mental disorders (depression, schizophrenia, etc.) or sleep disorders (such as insomnia, sleep apnea, etc.) before pregnancy, or taking analgesia, sedation, antidepressants; 2. Cognitive dysfunction or communication disorders; 3. There were severe pregnancy complications (such as severe preeclampsia, placenta accreta, HELLP syndrome, placenta previa, placental abruption,and those who undergo cervical cerclage due to a history of adverse pregnancy and childbirth), combined with severe organ dysfunction or endocrine diseases of heart, liver and kidney, or ASA grade >= III; 4. There are contraindications to the use of dexmedetomidine (such as hypotension, heart rate < 60 beats/min, cardiac conduction block, cardiac insufficiency, allergy to dexmedetomidine and its components);

Design outcomes

Primary

MeasureTime frame
The incidence of sleep disorders ;

Secondary

MeasureTime frame
Prenatal Pittsburgh sleep quality index(PSQI)score;NRS of subjective sleep quality score ;Prenatal Pittsburgh sleep quality index(PSQI) score and Insomnia Severity Index(ISI)score ;Edinburgh Postnatal Depression Scale(EPDS) score and Self-Rating Anxiety Scale(SAS)score ;Intraoperative pain score and sedation score;Postpartum hospital stay;

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