Perioperative Dexmedetomidine to Reduce Post-procedure Grief Following Second-trimester Dilation and Evacuation
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Reproductive Grief Screen
研究概览
简要总结
People seeking second-trimester dilation and evacuation (D&E) procedures are often facing profoundly challenging circumstances, including desired pregnancies complicated by fetal anomalies or demise, serious maternal health conditions, or changes in financial or relationship status. Although abortion regret is uncommon, the emotional burden surrounding these experiences is substantial: many patients experience significant grief and post-traumatic stress symptoms in the weeks to months following care. Perioperative interventions that decrease the body's stress response offer a promising opportunity to reduce downstream psychologic morbidity. Dexmedetomidine has been shown to reduce PTSD symptoms in other high-stress medical and surgical settings. The investigators are undertaking a randomized trial to evaluate whether perioperative administration of dexmedetomidine during second-trimester D&E can reduce the frequency and severity of post-procedural grief, directly addressing an unmet need in patient-centered, trauma-informed abortion care.
详细描述
The investigators will conduct a double-blinded, randomized, placebo-controlled, superiority trial of those undergoing D&E between 16 and 26-weeks gestation at Stanford Health Care to evaluate the following aims:
Aim 1: To assess the effect of perioperative dexmedetomidine on validated measures of grief in patients undergoing second-trimester D&E.
Aim 2: To evaluate the feasibility and implementation of perioperative dexmedetomidine within the routine workflow of outpatient OR-based D&E procedures.
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 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •English- or Spanish-fluency
- •16-26 weeks gestation
- •D&E in the operating room
排除标准
- •Unscheduled or emergent procedure
- •Contraindication to dexmedetomidine per package insert
- •Judgement of clinical anesthesiologist providing care
研究组 & 干预措施
Dexmedetomidine
Infused 0.5ug/kg over 10 minutes at anesthesia induction
干预措施: Dexmedetomidine (IV) 0.5 mcg/kg (Drug)
Placebo
Saline at equal volume to intervention group
干预措施: Placebo (Drug)
结局指标
主要结局
Reproductive Grief Screen
时间窗: 2 weeks post-procedure
Validated 5-question survey to evaluate for pathologic grief
次要结局
- Edinburgh Postnatal Depression Scale [EDPS](2 weeks post-procedure)
- PTSD Checklist for DSM-5 (PCL-5)(2 weeks post-procedure)
- Post-anesthesia care unit (PACU) length of stay(Immediately post-procedure (up to 6 hours))
- Reproductive Grief Screen(4 weeks post-procedure)
- Edinburgh Postnatal Depression Scale [EDPS](4 weeks post-procedure)
- PTSD Checklist for DSM-5 (PCL-5)(4 weeks post-procedure)
