A Phase 4 interventional study of Esketamine 0.2 mg/kg and Esketamine 0.2 mg/kg + dexmedetomidine 0.1 µg/kg in Cesarean Delivery, Esketamine and Neuropsychiatric Symptoms, sponsored by Peking University First Hospital. Completed at 1 site in China. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-12-30.
Sponsored by Peking University First Hospital · Phase 4, Interventional, and Prevention
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.
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.
Peking University First Hospital is the lead sponsor of 378 studies on the registry; 178 are open to participants now.
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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
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 0.1 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 0.15 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.
Drug: Esketamine 0.2 mg/kg + dexmedetomidine 0.2 µg/kg
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.
Incidence of dissociation within 24 hours.
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.
Time frame: Up to 24 hours after study drug infusion.
Severity of dissociative symptoms at different timepoints within 24 hours.
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.
Time frame: Up to 24 hours after study drug infusion.
Prevelance of dissociation at different timepoints within 24 hours.
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.
Time frame: Up to 24 hours after study drug infusion.
Incidence of neuropsychiatric adverse events within 24 hours.
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.
Time frame: Up to 24 hours after study drug infusion.
Prevalence of neuropsychiatric adverse events at different timepoints within 24 hours.
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.
Time frame: Up to 24 hours after study drug infusion.
Duration of sedation within 24 hours.
Agitation-sedation level is assessed with the Richmond Agitation-Sedation Scale (RASS, score ranges from -5 \[unarousable\] to 4 \[combative\] and 0 indicates alert and calm) and recorded every 5 minutes during, every 10 minutes after, and at 2 hours and 24 hours after study drug infusion. A RASS score of \<-1 is defined as presence of sedation.
Time frame: Up to 24 hours after study drug infusion.
Pain intensity within 7 days postpartum.
Pain intensity is assessed with the Numeric Rating Scale (NRS; an 11-point scale where 0=no pain and 10=the worst pain), both at rest and with movement, at 2 and 24 hours after study drug infusion and at 7 days postpartum.
Time frame: Up 7 days postpartum.
Proportion of exclusive breastfeeding.
Proportion of exclusive breastfeeding at 24 hours and 7 days postpartum.
Time frame: Up to 7 days postpartum.
Length of stay in hospital after surgery.
Length of stay in hospital after surgery.
Time frame: Up to 7 days postpartum.
Maternal and neonatal complications within 7 days.
Maternal and neonatal complications are defined as any medical conditions that required hospital visits and therapeutic intervention.
Time frame: Up to 7 days postpartum.
Maternal depression score at 7 days postpartum.
Maternal depression is assessed with the Edinburgh Postnatal Depression Scale (EPDS; scores range from 0 to 30, with higher score indicating more severe depression) at 7 days postpartum. An EPDS score of ≥10 is defined as having depressive symptoms.
Time frame: At 7 days postpartum.
Plan to share: No
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Peking University First Hospital