Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2022-04-30
2024-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Remifentanil-dexmedetomidine
Remifentanil-dexmedetomidine
Compare adequacy of remifentanil-dexmedetomidine sedation protocols in pregnant patients undergoing minimally invasive fetoscopic procedures.
Dexmedetomidine- fentanyl
Dexmedetomidine-fentanyl
Compare adequacy of dexmedetomidine-fentanyl sedation protocols in pregnant patients undergoing minimally invasive fetoscopic procedures.
Interventions
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Remifentanil-dexmedetomidine
Compare adequacy of remifentanil-dexmedetomidine sedation protocols in pregnant patients undergoing minimally invasive fetoscopic procedures.
Dexmedetomidine-fentanyl
Compare adequacy of dexmedetomidine-fentanyl sedation protocols in pregnant patients undergoing minimally invasive fetoscopic procedures.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Children's Hospital Medical Center, Cincinnati
OTHER
Responsible Party
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Principal Investigators
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Mario Patino, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Other Identifiers
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2022-0168
Identifier Type: -
Identifier Source: org_study_id