Different Doses of Dexmedetomidine Combined With Esketamine in Women Undergoing Cesarean Delivery
- Conditions
- Cesarean DeliveryEsketamineNeuropsychiatric SymptomsDexmedetomidine
- Interventions
- Registration Number
- NCT06613243
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Esketamine 0.2 mg/kg + dexmedetomidine 0.15 µg/kg 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. Esketamine 0.2 mg/kg 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. Esketamine 0.2 mg/kg + dexmedetomidine 0.1 µg/kg 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. Esketamine 0.2 mg/kg + dexmedetomidine 0.2 µg/kg 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.
- Primary Outcome Measures
Name Time Method Incidence of dissociation within 24 hours. Up to 24 hours after study drug infusion. Dissociative symptoms is assessed with the Clinician-Administered Dissociative States Scale (CADSS; scores range from 0 to 92, with higher score indicating more severe symptoms) at the end of study drug infusion and at 1, 2, and 24 hours after study drug infusion. A CADSS score of \>4 points at any timepoint indicates occurrence of dissociative symptoms.
- Secondary Outcome Measures
Name Time Method Severity of dissociative symptoms at different timepoints within 24 hours. Up to 24 hours after study drug infusion. Dissociation symptoms is assessed with the Clinician-Administered Dissociative States Scale (CADSS; scores range from 0 to 92, with higher score indicating more severe symptoms) at the end of study drug infusion and at 1, 2, and 24 hours after study drug infusion.
Prevelance of dissociation at different timepoints within 24 hours. Up to 24 hours after study drug infusion. Dissociation symptoms is assessed with the Clinician-Administered Dissociative States Scale (CADSS; scores range from 0 to 92, with higher score indicating more severe symptoms) at the end of study drug infusion and at 1, 2, and 24 hours after study drug infusion.
Incidence of neuropsychiatric adverse events within 24 hours. Up to 24 hours after study drug infusion. Neuropsychiatric symptoms are evaluated with a structured checklist at 5-minute intervals during, at 10-minute intervals after, and at 2 and 24 hours after study drug infusion. Severity of symptoms is classified as mild (report symptoms on inquiry), moderate (report symptoms without inquiry), or severe (required intervention such as stop study drug infusion and/or give medications). A severity of moderate or above is recorded as presence of neuropsychiatric symptoms.
Prevalence of neuropsychiatric adverse events at different timepoints within 24 hours. Up to 24 hours after study drug infusion. Neuropsychiatric symptoms are evaluated with a structured checklist every 5 minutes during, every 10 minutes after, and at 2 and 24 hours after study drug infusion. Severity of symptoms is classified as mild (report symptoms on inquiry), moderate (report symptoms without inquiry), or severe (required intervention such as stop study drug infusion and/or give medications). A severity of moderate or above is defined as presence of neuropsychiatric symptoms.