Different Doses of Dexmedetomidine Combined With Esketamine for Analgesia in Women Undergoing Cesarean Delivery: a Pilot Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 主要终点
- Incidence of dissociation within 24 hours.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: Esketamine 0.2 mg/kg (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.
干预措施: Esketamine 0.2 mg/kg + dexmedetomidine 0.1 µg/kg (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.
干预措施: Esketamine 0.2 mg/kg + dexmedetomidine 0.15 µg/kg (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.
干预措施: Esketamine 0.2 mg/kg + dexmedetomidine 0.2 µg/kg (Drug)
结局指标
主要结局
Incidence of dissociation within 24 hours.
时间窗: 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.
次要结局
- Severity of dissociative symptoms at different timepoints within 24 hours.(Up to 24 hours after study drug infusion.)
- Prevelance of dissociation at different timepoints within 24 hours.(Up to 24 hours after study drug infusion.)
- Incidence of neuropsychiatric adverse events within 24 hours.(Up to 24 hours after study drug infusion.)
- Prevalence of neuropsychiatric adverse events at different timepoints within 24 hours.(Up to 24 hours after study drug infusion.)