Comparison of Remifentanil-dexmedetomidine and Dexmedetomidine-fentanyl Sedation Protocols for Pregnant Patients Undergoing Minimally Invasive Fetoscopic Procedures
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Determine surgeon satisfaction with dexmedetomidine-fentanyl sedation
研究概览
简要总结
Determine surgeon and patient satisfaction with remifentanil-dexmedetomidine (REMI) and dexmedetomidine-fentanyl (DEX) sedation protocols in pregnant patients undergoing minimally invasive fetoscopic procedures
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
盲法说明
Participant and surgeon will be blinded to which combination of medications are used during the procedure.
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
- •Pregnant patients undergoing one of the following procedures
- •Laser photocoagulation of abnormal anastomotic vessels in patients with a twin-twin transfusion syndrome
- •Selective radiofrequency ablation or fetoscopic cord coagulation in patients with TRAP sequence or in the presence of intrauterine death of one twin
- •Vesicoamniotic shunts or placement of amnioports in patients with LUTO
- •Placement of amnioports in patients with oligohydramnios or anhydramnios
- •Fetal thoracentesis or placement of thoracoamniotic shunts in patients with congenital pulmonary airway malformation or fetal hydrothorax
- •FETO (fetoscopic endotracheal occlusion) as well as balloon removal in patients with congenital diaphragmatic hernia and laser release of amniotic bands
排除标准
- •Pregnant patients undergoing fetoscopic procedures requiring the following
- •Additional procedures (e.g. cerclage)
- •Laparotomy with uterine exteriorization to access the uterine cavity
- •General anesthesia
- •Mid-gestation neural tube defect repair
- •EXIT procedures
- •Preoperative opioid use
- •Diagnosed substance abuse
- •Moderate to severe obstructive sleep apnea
- •History of allergic reactions to medications to be administered during the study
研究组 & 干预措施
Remifentanil-dexmedetomidine
干预措施: Remifentanil-dexmedetomidine (Drug)
Dexmedetomidine- fentanyl
干预措施: Dexmedetomidine-fentanyl (Drug)
结局指标
主要结局
Determine surgeon satisfaction with dexmedetomidine-fentanyl sedation
时间窗: Immediately after procedure completion
Surgeons will use a scale of 1-4, 1 - Excellent, 2 - Good, 3 - Moderate, 4 - Inadequate
Determine surgeon satisfaction with remifentanil-dexmedetomidine sedation
时间窗: Immediately after procedure completion
Surgeons will use a scale of 1-4, 1 - Excellent, 2 - Good, 3 - Moderate, 4 - Inadequate
Determine patient satisfaction with dexmedetomidine-fentanyl sedation
时间窗: 6 hours after procedure completion
Iowa Satisfaction with Anesthesia Scale (ISAS) 11 question survey rating anesthesia experience. Six response options from disagree very much to agree very much
Determine patient satisfaction with remifentanil-dexmedetomidine sedation
时间窗: 6 hours after procedure completion
Iowa Satisfaction with Anesthesia Scale (ISAS) 11 question survey rating anesthesia experience. Six response options from disagree very much to agree very much
次要结局
- Side-effect measures(Up 24 hours after procedure)
- Sedation scores(Every 15 minutes from start of procedure to one hour post-operative)