NCT06613243

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Peking University First Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Esketamine is a commonly used anesthetic and analgesic drug during the perioperative period. Recent studies found that low-dose esketamine has rapid onset antidepressant effects and reduces postpartum depression when administered during cesarean delivery. However, even low-dose esketamine produces transient neuropsychiatric symptoms. Dexmedetomidine is a high selective alpha2-adrenoceptor agonist and has both sedative and analgesic effects. When used in combination with esketamine, dexmedetomidine reduces esketamine related neuropsychiatric adverse reactions in patients undergoing general anesthesia. The investigator speculate that combining low-dose dexmedetomidine with esketamine may also reduce neuropsychiatric adverse effects of esketamine in women undergoing cesarean delivery. The purpose of this pilot trial is to determine the minimum dose of dexmedetomidine that can effectively prevent neuropsychiatric side effects of antidepressve dose esketamine (0.2mg/kg) in women undergoing cesarean delivery.

Conditions

• Cesarean Delivery
• Esketamine
• Neuropsychiatric Symptoms
• Dexmedetomidine

Interventions

Type	Name	Description
DRUG	Esketamine 0.2 mg/kg	Esketamine 0.2 mg/kg is diluted in 20 ml normal saline and infused over 40 minutes after clamping the umbilical cord.
DRUG	Esketamine 0.2 mg/kg + dexmedetomidine 0.1 µg/kg	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.
DRUG	Esketamine 0.2 mg/kg + dexmedetomidine 0.15 µg/kg	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.
DRUG	Esketamine 0.2 mg/kg + dexmedetomidine 0.2 µg/kg	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.

Timeline

• Start date: 2024-10-08
• Primary completion: 2024-12-02
• Completion: 2024-12-09
• First posted: 2024-09-25
• Last updated: 2024-12-30

Locations

1 site across 1 country: China