CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 120 enrolled
Drug / intervention
Esketamine 0.2 mg/kg +3 moredrug
Likely dose
Esketamine 0.2 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06613243
NCT06613243Phase 4Completed

Different Doses of Dexmedetomidine Combined With Esketamine for Analgesia in Women Undergoing Cesarean Delivery: a Pilot Randomized Trial

Peking University First Hospital·interventional·Posted Sep 25, 2024·Updated Dec 30, 2024

In Brief

A Phase 4 clinical trial evaluating Esketamine 0.2 mg/kg, Esketamine 0.2 mg/kg + dexmedetomidine 0.1 µg/kg, and 2 other interventions for Cesarean Delivery and 3 related conditions. Completed, enrolled 120 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 4CompletedFinished
20252026
First PostedSep 25, 2024
Enrollment StartOct 8, 2024
Primary CompletionDec 2, 2024
Study CompletionDec 9, 2024
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 1.8 years ago

Interventions

Esketamine 0.2 mg/kgdrug

Esketamine 0.2 mg/kg is diluted in 20 ml normal saline and infused over 40 minutes after clamping the umbilical cord.

Esketamine 0.2 mg/kg + dexmedetomidine 0.1 µg/kgdrug

A mixture of esketamine 0.2 mg/kg and dexmedetomidine 0.1 µg/kg is diluted in 20 ml normal saline and infused over 40 minutes after clamping the umbilical cord.

Esketamine 0.2 mg/kg + dexmedetomidine 0.15 µg/kgdrug

A mixture of esketamine 0.2 mg/kg and dexmedetomidine 0.15 µg/kg is diluted in 20 ml normal saline and infused over 40 minutes after clamping the umbilical cord.

Esketamine 0.2 mg/kg + dexmedetomidine 0.2 µg/kgdrug

A mixture of esketamine 0.2 mg/kg and dexmedetomidine 0.2 µg/kg is diluted in 20 ml normal saline and infused over 40 minutes after clamping the umbilical cord.