Comparing Fetoscopic Surgery Protocols

• Status: Withdrawn
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

Determine surgeon and patient satisfaction with remifentanil-dexmedetomidine (REMI) and dexmedetomidine-fentanyl (DEX) sedation protocols in pregnant patients undergoing minimally invasive fetoscopic procedures

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital Medical Center, Cincinnati
• Treatments: Dexmedetomidine; Fentanyl; Remifentanil

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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