Sevoflurane as an Anesthetic During Dilation and Evacuation Procedures: Does it Increase Blood Loss and Interventions for Blood Loss and Why Do Anesthesiologists Choose to Use It?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Number of Participants Needing Intervention to Treat Blood Loss (a Composite of Use of Uterotonics, Re-aspiration, and Bimanual Massage)
研究概览
简要总结
Sevoflurane is an FDA-approved anesthetic drug commonly used for anesthesia during second trimester abortion procedures. It has a few advantages, including ease of use by the anesthesia provider. However, the literature suggests that when used in doses higher than those used at Oregon Health & Science University (OHSU) and Lovejoy, it is associated with an increase in the risk of bleeding. The investigators study aims to test whether the lower dose used at OHSU and Lovejoy during second trimester abortion procedures causes any difference in blood loss, when compared to similar abortion procedures for which this drug is not used.
详细描述
This study seeks to examine the bleeding complications associated with use of sevoflurane in general anesthesia regimens for second trimester abortion procedures and assess anesthesia providers' use and beliefs regarding possible risks associated with newer inhalational agents such as sevoflurane in this setting. Participants' anesthesia will either be intravenous (IV) propofol, IV midazolam, IV fentanyl and nitrous oxide or this same regimen combined with sevoflurane during maintenance of anesthesia. Procedural outcomes, specifically those related to bleeding complications, including need to intervene for excess blood loss, will be recorded and analyzed to establish if such a relationship between use of sevoflurane and excess blood loss exists.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Voluntarily requesting pregnancy termination
- •Estimated gestational age of 18 weeks - 23 weeks, 6 days gestational age as calculated by fetal biparietal diameter on clinic ultrasound.
- •Be able and willing to sign an informed consent and agree to terms of the study
排除标准
- •Known severe maternal respiratory disease or upper respiratory infection or sinus blockage
- •Anticoagulation use: within 24 hours if Lovenox, or within 12 hours if heparin, (Must have a documented normal international normalized ratio (INR) prior to procedure if on anticoagulation)
- •Multiple pregnancy
- •Fetal demise, if more than 2 weeks difference exists between known gestational age (by previous US dating) and gestational size on current ultrasound.
- •Known allergy/sensitivity to sevoflurane or any other inhaled anesthetic agents
研究组 & 干预措施
Sevoflurane
Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.
干预措施: Sevoflurane (Drug)
No Sevoflurane
Subject receives standard of care drug regimens for anesthesia with this procedure.
干预措施: No Sevoflurane (Other)
结局指标
主要结局
Number of Participants Needing Intervention to Treat Blood Loss (a Composite of Use of Uterotonics, Re-aspiration, and Bimanual Massage)
时间窗: At time of uterine evacuation and immediately post-operatively, an average of 7.1 minutes
Provider report for need to intervene due to blood loss (yes/no)
次要结局
- Number of Participants With Estimated Blood Loss Greater Than 300 mL (Yes/no)(At time of uterine evacuation, an average of 7.1 minutes)
- Number of Participants Experiencing Side Effects (Nausea, Dizziness)(Post-procedure, within 30 minutes)
- Procedure Time: T-test (Time of Speculum Placement to Time Speculum Removed)(Time of speculum place to time of speculum removal, an average of 7.1 minutes)
- Patient and Provider Satisfaction With Anesthesia(Post-procedure, within 30 minutes)
研究者
Rosanne Botha
Master of Public Health Student, MD
Oregon Health and Science University