New epidural mix could make labor safer for moms and babies
NCT ID NCT07145775
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study tested a new epidural pain relief combination (dexmedetomidine, esketamine, and ropivacaine) against the standard mix (sufentanil and ropivacaine) in 300 women during labor. The goal was to see if the new combo works as well for pain and is safer for newborns. It's a pilot trial to check if a larger study is possible.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- dexmedetomidine, esketamine, and ropivacaine combination
- What this could lead to
- If this works, it could offer a safer or equally effective alternative for pain relief during labor, with fewer side effects for mothers and newborns.
- What could go wrong
- This is a small pilot study, so results may not be conclusive. The new combination might not be as effective or could have unexpected risks compared to the standard treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
300 people
The number who actually took part.
- Started
-
Sep 2025
- Finished
-
Mar 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Female participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Aged 18 years or above; 2. Single term cephalic pregnancy preparing for vaginal delivery; 3. Agreed to receive epidural labor analgesia. Exclusion Criteria: 1. History of schizophrenia or epilepsy; 2. Presence of contraindications for epidural analgesia, including: (1) history of infectious disease of the central nervous system (poliomyelitis, cerebrospinal meningitis, encephalitis, etc.); (2) history of spinal or intra-spinal disease (trauma or surgery of spinal column, intra-spinal canal mass, etc.); (3) systemic infection (sepsis); (4) skin or soft tissue infection at the site of epidural puncture; (5) coagulopathy. 3. Relative contraindications for the use of dexmedetomidine, including prenatal bradycardia (HR\<60 beats per minute) and second-degree or higher atrioventricular block; 4. Relative contraindications for the use of esketamine, including uncontrolled hypertension (systolic blood pressure \>180 mmHg) and hyperthyroidism; 5. Not well controlled systemic diseases, including heart disease, liver disease, kidney disease, or an ASA classification \>III; 6. Other conditions that are considered unsuitable for study participation.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
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