Comparing Fetoscopic Surgery Protocols

Conditions: Minimally Invasive Fetoscopic Procedures

Sex: Female

Ages: 18 Years – N/A

Phase: NA

Sponsor: Children's Hospital Medical Center, Cincinnati

Summary

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

Eligibility Criteria

Inclusion Criteria:Pregnant patients undergoing one of the following proceduresLaser photocoagulation of abnormal anastomotic vessels in patients with a twin-twin transfusion syndromeSelective radiofrequency ablation or fetoscopic cord coagulation in patients with TRAP sequence or in the presence of intrauterine death of one twinVesicoamniotic shunts or placement of amnioports in patients with LUTOPlacement of amnioports in patients with oligohydramnios or anhydramniosFetal thoracentesis or placement of thoracoamniotic shunts in patients with congenital pulmonary airway malformation or fetal hydrothoraxFETO (fetoscopic endotracheal occlusion) as well as balloon removal in patients with congenital diaphragmatic hernia and laser release of amniotic bandsExclusion Criteria:Pregnant patients undergoing fetoscopic procedures requiring the followingAdditional procedures (e.g. cerclage)Laparotomy with uterine exteriorization to access the uterine cavityGeneral anesthesiaMid-gestation neural tube defect repairEXIT proceduresPreoperative opioid useDiagnosed substance abuseModerate to severe obstructive sleep apneaHistory of allergic reactions to medications to be administered during the study

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Source: ClinicalTrials.gov (NCT05654064). StuddyBuddy aggregates publicly available trial information.