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Clinical study of Programmable Intermittent Epidural of Dexmedetomidine combined with ropivacaine for labor analgesia

Clinical Effect Observation of Programmed Intermittent Epidural Bolus Administration of Dexmedetomidine Combined with Ropivacaine for Labor Analgesia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122400
Enrollment
Unknown
Registered
2026-04-13
Start date
2026-02-26
Completion date
Unknown
Last updated
2026-04-20

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

Conditions

Labor Pain

Interventions

Group A:0.1% ropivacaine + 0.5 µg/ml dexmedetomidine
Group B:0.1% ropivacaine + 0.5 µg/ml sufentanil
Group C:0.1% ropivacaine

Sponsors

Shenzhen Luohu Maternal and Child Health Care Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Pregnant women aged 18-40 years with full-term pregnancy (>=37 weeks of gestational age), single fetus in cephalic position; 2. Planned for vaginal delivery after obstetric assessment; 3. American Society of Anesthesiologists (ASA) physical status class II; 4. Cervical dilation between 2 and 5 cm on admission, and voluntarily requested epidural labor analgesia; 5. No severe dysfunction of vital organs such as heart, lung, liver, and kidney; 6. No severe endocrine diseases, organic neurological diseases, or psychiatric diseases; 7. Physical condition assessed by anesthesiologists to be tolerable to the labor process and epidural anesthesia; 8. No contraindications to epidural/intrathecal anesthesia (e.g., spinal deformity, infection at puncture site, coagulation dysfunction, etc.); 9. No history of allergy to ropivacaine, dexmedetomidine, or other study-related medications; 10. The parturient and her family have fully understood the purpose, methods, risks, and benefits of the study and have voluntarily signed the written informed consent form.

Exclusion criteria

Exclusion criteria: 1. Multiple pregnancies, preterm birth (gestational age 35 kg/m², assessed as extremely difficult to perform epidural puncture and unable to guarantee success rate; 10. History of allergy to ropivacaine, dexmedetomidine, or other amide local anesthetics; 11. Use of opioid analgesics, sedative-hypnotics, or psychotropic drugs within 48 hours before enrollment; 12. History of opioid addiction, chronic alcoholism, or participation in other drug clinical trials; 13. The parturient or her family refuses to sign the informed consent form, or voluntarily withdraws from the study midway; 14. Abnormal mental or cognitive function, unable to understand the study process, cooperate with analgesic effect evaluation and postoperative follow-up; 15. Unable to complete the observation period specified in the study due to personal reasons, or at high risk of loss to follow-up.

Design outcomes

Primary

MeasureTime frame
Onset time of analgesia;NRS pain score during labor;

Secondary

MeasureTime frame
Degree of Motor Blockade;onsumption of analgesic drugs;Maternal delivery-related outcomes;Adverse reactions for mothers and infants;

Countries

China

Contacts

Public ContactZhang Yuan

Shenzhen Luohu Maternal and Child Health Care Hospital

924608217@qq.com+86 135 1082 9931

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 23, 2026