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Completed

NCT Number: NCT03064607

Neurodegeneration in Newborns After Anesthetics

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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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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%

  • After the baby is delivered, and the umbilicus is cut, two ml of blood will be taken from the umbilical vein and artery on the placenta side. A portion of the blood will be used for the blood gas and the remainder will be used for the S100B study assay.
  • 5 ml of blood will be taken from the mother via the existing intravenous catheter.
  • 5 ml of amniotic fluid will be obtained at hysterotomy and will be used for the S100B study assay.

All subjects will receive standard of care post operative clinical care and monitoring.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women delivering a child via cesarean section or EXIT procedure
  • Informed consent

Exclusion criteria

  • Known fetal neurologic defect
  • Known maternal neurologic abnormality
  • Sensitivity or allergy to medications used in the study
  • 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%

Treatment and study plan

Fluid collection

Other

Fluids tested for biomarker S100beta

Primary outcomes

  1. S100β Umbilical

    Time frame: 1 day

    as measured by the concentration of biomarker in umbilical arterial and venous blood

Secondary outcomes

  1. S100β Amniotic

    Time frame: 1 day

    as measured by the concentration of biomarker in maternal amniotic fluid

  2. S100β Blood

    Time frame: 1 day

    as measured by the concentration of biomarker in maternal blood

  3. Blood gas

    Time frame: 1 day

    as measured by the results of umbilical arterial and venous blood

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Children's Hospital of Philadelphia

Registry information

Official study title

Measurement of Biomarkers of Neurodegeneration in Newborns After Exposure to Anesthetics

Important dates

Study start
2010
Primary completion
2018
Study completion
2018
First posted
Feb 27, 2017
Registry last updated
Feb 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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