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NCT Number: NCT06613243

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

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.

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Key information

Conditions

Cesarean Delivery Dexmedetomidine Esketamine Neuropsychiatric Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant women aged ≥18 years.
  • Scheduled for elective or emergency cesarean delivery under neuraxial anesthesia.

Exclusion criteria

  • A previous history of schizophrenia;
  • Severe complications of pregnancy, such as pre-eclampsia, placenta accreta spectrum, or HELLP (intravascular haemolysis, elevated liver enzymes, and low platelet count) syndrome; or American Society of Anesthesiologists classification III or higher;
  • Any contraindications to ketamine or esketamine, such as refractory hypertension, severe cardiovascular disease, or hyperthyroidism;
  • Any contraindications to dexmedetomidine, such as sick sinus syndrome, severe sinus bradycardia (<50 beats per minute), or second-degree or above atrioventricular block without pacemaker;
  • Other conditions that are considered unsuitable for study participation.

Treatment and study plan

Esketamine 0.2 mg/kg

Drug

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

Drug

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/kg

Drug

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/kg

Drug

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 outcomes

  1. Incidence of dissociation within 24 hours.

    Time frame: 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 outcomes

  1. Severity of dissociative symptoms at different timepoints within 24 hours.

    Time frame: 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.

  2. Prevelance of dissociation at different timepoints within 24 hours.

    Time frame: 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.

  3. Incidence of neuropsychiatric adverse events within 24 hours.

    Time frame: 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.

  4. Prevalence of neuropsychiatric adverse events at different timepoints within 24 hours.

    Time frame: 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.

Other outcomes

  1. Duration of sedation within 24 hours.

    Time frame: Up to 24 hours after study drug infusion.

    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.

  2. Pain intensity within 7 days postpartum.

    Time frame: Up 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.

  3. Proportion of exclusive breastfeeding.

    Time frame: Up to 7 days postpartum.

    Proportion of exclusive breastfeeding at 24 hours and 7 days postpartum.

  4. Length of stay in hospital after surgery.

    Time frame: Up to 7 days postpartum.

    Length of stay in hospital after surgery.

  5. Maternal and neonatal complications within 7 days.

    Time frame: Up to 7 days postpartum.

    Maternal and neonatal complications are defined as any medical conditions that required hospital visits and therapeutic intervention.

  6. Maternal depression score at 7 days postpartum.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 25, 2024
Registry last updated
Dec 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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