University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
NCT Number: NCT03064607
The purpose of the study is to quantify biomarkers of neural damage in neonates exposed to varying levels of volatile anesthetic in utero.
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Notify Me18 year and older
Female
Observational
Philadelphia, Pennsylvania, 19104, United States
This study will enroll 130 pregnant patients undergoing C-section or fetal surgery with EXIT (Ex Utero Intrapartum Treatment) procedures under epidural or general anesthesia with low (0.75 MAC) or high (2.5 MAC) concentrations of desflurane. Patients will be recruited from both the Hospital of the University of Pennsylvania (100 C Section) and Children's Hospital of Philadelphia (30 EXIT procedure).
The standard of care protocol for patients undergoing anesthesia for these cases will be followed throughout the surgery. These include monitoring and management of blood pressure, heart rate and rhythm, ventilation, oxygenation, temperature, and fluid status. Management of these parameters will be at the discretion of the clinical team. The choice of the anesthetic technique will also be at the discretion of the clinical team. Typical anesthetic management includes the following:
C-section under epidural anesthesia: induction and maintenance with 1.5% lidocaine, sodium bicarbonate and 1:200,000 epinephrine
C-section under general anesthesia: induction with propofol 2 mg/kg and succinylcholine 2 mg/kg intravenously; maintenance with desflurane 4.5-5%
EXIT procedure under general anesthesia: induction with propofol 2 mg/kg and succinylcholine 2 mg/kg intravenously; maintenance with desflurane 15-18%
All subjects will receive standard of care post operative clinical care and monitoring.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Fluids tested for biomarker S100beta
Time frame: 1 day
as measured by the concentration of biomarker in umbilical arterial and venous blood
Time frame: 1 day
as measured by the concentration of biomarker in maternal amniotic fluid
Time frame: 1 day
as measured by the concentration of biomarker in maternal blood
Time frame: 1 day
as measured by the results of umbilical arterial and venous blood
University of Pennsylvania
Other
Measurement of Biomarkers of Neurodegeneration in Newborns After Exposure to Anesthetics
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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