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CompletedPhase 4

Different Doses of Dexmedetomidine Combined With Esketamine in Women Undergoing Cesarean Delivery

NCT06613243 · Peking University First Hospital

Closed to entry
Status
Not accepting participants
Phase 4
Phase
120
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

Esketamine is a commonly used analgesic during cesarean delivery, but may produce transient neuropsychiatric symptoms. Dexmedetomidine has both sedative and analgesic effects. When used in combination with esketamine, dexmedetomidine can reduce esketamine related neuropsychiatric effects after general anesthesia. The investigator speculate that combining low-dose dexmedetomidine with esketamine may also reduce neuropsychiatric adverse effects of esketamine in women undergoing cesarean section. This pilot trial is designed to determine the minimum dose of dexmedetomidine that can effectively prevent neuropsychiatric side effects of antidepressive dose esketamine (0.2mg/kg) in women undergoing cesarean delivery.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Incidence of dissociation within 24 hours.

    Measured over Up to 24 hours after study drug infusion.

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 45 Years
Ages
FEMALE
Sex
Not accepted
Healthy volunteers
Inclusion criteria: * Pregnant women aged ≥18 years. * Scheduled for elective or emergency cesarean delivery under neuraxial anesthesia. Exclusion criteria: * A previous history of schizophrenia; * Severe complications of pregnancy, such as pre-eclampsia, placenta accreta spectrum, or HELLP (intravascular haemolysis, elevated liver enzymes, and low platelet count) syndrome; or American Society of Anesthesiologists classification III or higher; * Any contraindications to ketamine or esketamine, such as refractory hypertension, severe cardiovascular disease, or hyperthyroidism; * Any contraindications to dexmedetomidine, such as sick sinus syndrome, severe sinus bradycardia (\<50 beats per minute), or second-degree or above atrioventricular block without pacemaker; * Other conditions that are considered unsuitable for study participation.

Where

1 study site

FacilityCityRegionCountry
Peking University First HospitalBeijingBeijing MunicipalityChina

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT06613243 on ClinicalTrials.gov →

Last updated in the registry 2024-12-30. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

All 7 trials from Peking University First Hospital →