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| Name | Class |
|---|---|
| Children's Hospital of Philadelphia | OTHER |
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The purpose of the study is to quantify biomarkers of neural damage in neonates exposed to varying levels of volatile anesthetic in utero.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pregnant women | Women undergoing c-section or EXIT procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluid collection | Other | Fluids tested for biomarker S100beta |
|
| Measure | Description | Time Frame |
|---|---|---|
| S100β Umbilical | as measured by the concentration of biomarker in umbilical arterial and venous blood | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| S100β Amniotic | as measured by the concentration of biomarker in maternal amniotic fluid | 1 day |
| S100β Blood | as measured by the concentration of biomarker in maternal blood |
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Inclusion Criteria:
Exclusion Criteria:
Known fetal neurologic defect
Known maternal neurologic abnormality
Sensitivity or allergy to medications used in the study
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pregnant women
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| Name | Affiliation | Role |
|---|---|---|
| Huafeng Wei, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Term |
|---|---|
| D009410 | Nerve Degeneration |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Plasma
| 1 day |
| Blood gas | as measured by the results of umbilical arterial and venous blood | 1 day |