Comparing Fetoscopic Surgery Protocols

Cincinnati Children's Hospital Medical Center

Status

Withdrawn

Conditions

Minimally Invasive Fetoscopic Procedures

Treatments

Drug: Remifentanil-dexmedetomidine

Drug: Dexmedetomidine-fentanyl

Study type

Interventional

Funder types

Other

Identifiers

NCT05654064

2022-0168

Details and patient eligibility

About

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

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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