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NOT YET RECRUITING
NCT07145775
PHASE4

Dexmedetomidine-esketamine-ropivacaine Versus Sufentanil-ropivacaine for Epidural Labor Analgesia

Sponsor: Peking University First Hospital

View on ClinicalTrials.gov

Summary

Sufentanil-ropivacaine combination is commonly used for epidural labor anesthesia, but is associated with some adverse events. Dexmedetomidine and esketamine, each has been effectively used for neuraxial anesthesia in combination with local anesthetics. Plenty of evidences show that both dexmedetomidine and esketamine, combined with ropivacaine, are also effective as the sufentanil-ropivacaine combination when used for epidural labor analgesia. This pilot trial is designed to evaluate the efficacy and safety of the dexmedetomidine-esketamine-ropivacaine versus sufentanil-ropivacaine combination for epidural labor analgesia, and to test the feasibility of a future large randomized trial.

Official title: Dexmedetomidine-esketamine-ropivacaine Versus Sufentanil-ropivacaine Combination for Epidural Labor Analgesia and Neonatal Outcomes: a Pilot Randomized Trial

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2025-08

Completion Date

2026-10

Last Updated

2025-08-28

Healthy Volunteers

No

Interventions

DRUG

sufentanil-ropivacaine combination

Epidural labor analgesia will be conducted using the sufentanil-ropivacaine combination (0.4 microgram/ml sufentanil + 0.072% ropivacaine).

DRUG

dexmedetomidine-esketamine-ropivacaine combination 1

Epidural labor analgesia will be conducted using the dexmedetomidine-esketamine-ropivacaine combination 1 (0.4 microgram/ml dexmedetomidine + 0.15 mg/ml esketamine + 0.036% ropivacaine).

DRUG

dexmedetomidine-esketamine-ropivacaine combination 2

Epidural labor analgesia will be conducted using the dexmedetomidine-esketamine-ropivacaine combination 2 (0.4 microgram/ml dexmedetomidine + 0.2 mg/ml esketamine + 0.036% ropivacaine).

Locations (1)

Peking University First Hospital

Beijing, Beijing Municipality, China