At a glance
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Different Doses of Dexmedetomidine Combined With Esketamine for Analgesia in Women Undergoing Cesarean Delivery: a Pilot Randomized Trial
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
Timeline
Interventions
Esketamine 0.2 mg/kg is diluted in 20 ml normal saline and infused over 40 minutes after clamping the umbilical cord.
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.
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.
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.