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

Peking University

Status and phase: Not yet enrolling; Phase 4

Conditions: Sufentanil; Labor Pain; Epidural Analgesia; Esketamine; Dexmedetomidine; Ropivacaine

Treatments: Drug: dexmedetomidine-esketamine-ropivacaine combination 2; Drug: sufentanil-ropivacaine combination; Drug: dexmedetomidine-esketamine-ropivacaine combination 1

Study type: Interventional

Funder types: Other

Identifiers

NCT07145775

2025R0269

Details and patient eligibility

About

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.

Full description

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.

The investigators hypothesize that the dexmedetomidine-esketamine-ropivacaine combination, by avoiding sufentanil and decreasing ropivacaine concentration, may provide non-inferior analgesia with less harmful effect on neonatal outcomes when compared with the sufentanil-ropivacaine combination. 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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 3 patient groups

control group

Active Comparator group

Description:

Epidural analgesia will be conducted with the sufentanil-ropivacaine combination (0.4 microgram/ml sufentanil + 0.072% ropivacaine; 100 microgram sufentanil + 18 ml 1% ropivacaine, diluted with normal saline to 250 ml).

Treatment:

Drug: sufentanil-ropivacaine combination

experimental group 1

Experimental group

Description:

Epidural analgesia will be conducted with the dexmedetomidine-esketamine-ropivacaine combination 1 (0.4 microgram/ml dexmedetomidine + 0.15 mg/ml esketamine + 0.036% ropivacaine; 100 microgram dexmedetomidine + 37.5 mg esketamine + 9 ml 1% ropivacaine, diluted with normal saline to 250 ml).

Treatment:

Drug: dexmedetomidine-esketamine-ropivacaine combination 1

experimental group 2

Experimental group

Description:

Epidural analgesia will be conducted with the dexmedetomidine-esketamine-ropivacaine combination 2 (0.4 microgram/ml dexmedetomidine + 0.2 mg/ml esketamine + 0.036% ropivacaine; 100 microgram dexmedetomidine + 50 mg esketamine + 9 ml 1% ropivacaine, diluted with normal saline to 250 ml).

Treatment:

Drug: dexmedetomidine-esketamine-ropivacaine combination 2