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Effect of Dexmedetomidine on Epidural-related maternal Fever:A Multicenter, Double Blind, Randomized Clinical Trial

Effect of Dexmedetomidine on Epidural-related maternal Fever:A Multicenter, Double Blind, Randomized Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110561
Enrollment
Unknown
Registered
2025-10-15
Start date
2025-10-31
Completion date
Unknown
Last updated
2025-10-20

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

Conditions

epidural related materna fever

Interventions

Group Sufentanil :0.5 µg/mL sufentanil and 0.075%ropivacaine for labor analgesia
Group Dexmedetomidine:0.25 µg/mL Dexmedetomidine, 0.25 µg/mL Sufentanil, and 0.075% Ropivacaine for Labor Analgesia.

Sponsors

Shanghai First Maternity and Infant Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. ASA Physical Status II -III; 2. Gestational age >=37 weeks; 3. Age >= 18 year; 4. Primiparous singleton pregnancies; 5. Planned to undergoing epidural labor analgesia.

Exclusion criteria

Exclusion criteria: 1.Contraindications to neuraxial anesthesia (e.g., coagulation disorders, , central nervous system diseases, etc.); 2. Body temperature >=37.5? at admission; 3. Group B Streptococcus (GBS) positive or other systemic infections; 4. Stillbirth; 5. Rupture of membranes >=6 hours; 6. Receipt of opioid or sedative medications within 4 hours prior to labor analgesia; 7. Allergy to sufentanyl, dexmedetomidine, or ropivacaine; 8. Inability to cooperate wiht the study for any reason; 9. Participation in other clinical trials within the 1 week prior to study enrollment.

Design outcomes

Primary

MeasureTime frame
The maternal fever rate during labor analgesia;

Secondary

MeasureTime frame
Hourly maternal tympanic temperature;NRS scores at hourly intervals before (baseline) and after the initiation of labor analgesia until delivery;Sensory block level during labor analgesia;Motor block assessed by Modified Bromage Scale during labor analgesia;Intrapartum cesarean delivery rate during labor analgesia;Incidence of postpartum hemorrhage (PPH) within 24 hours after delivery;Time to first breastfeeding postpartum;Length of postpartum hospital stay;Incidence of maternal complications within 42 days postpartum;Neonatal Apgar score;NICU admission rate;

Countries

China

Contacts

Public ContactShuangqiong Zhou

Shanghai First Maternity and Infant Hospital

zsq628628@163.com+86 139 1617 4158

Outcome results

None listed

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