Isoflurane-induced Neuroinflammation in Children With Hydrocephalus

• Status: Terminated
• Trial end date: 2017-10-31
• Target enrollment: 0
• Participant gender: All

Summary

The investigators will quantify inflammatory biomarkers in cerebrospinal fluid (CSF) and serum of children with hydrocephalus who are undergoing ventriculoperitoneal shunt placement under isoflurane anesthesia.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nationwide Children's Hospital
• Collaborator: Ohio State University
• Treatments: Dexmedetomidine; Isoflurane; Remifentanil

Criteria

Inclusion Criteria (HC study patients):

• Pediatric patients, aged 6 months-less than 11 years, diagnosed with hydrocephalus undergoing a primary surgical (non-bedside) shunting procedure with general anesthesia.

• Participants must have a parent/guardian who is able to provide written informed consent in accordance with human investigation committee guidelines.

• The shunting procedure must be an initial VPS placement (not a VPS revision).

Inclusion Criteria (MRI with general anesthesia: peripheral blood patients; anesthesia but no surgery):

• Otherwise healthy pediatric patients, aged 6 months-less than 11 years, undergoing MRI with general anesthesia for evaluation of non-neurologic, non-inflammatory disease.

• Participants must have a parent/guardian who is able to provide written informed consent in accordance with IRB guidelines.

Exclusion Criteria (HC study patients):

• Any active infection or infection within the last 14 days.

• Treatment in the last 48 hours with non-steroidal anti-inflammatory (NSAID) or corticosteroid medications.

• Anticoagulant administration in the last 48 hours.

• Treatment with any drug known to induce or suppress inflammation.

• Clinically unstable patients.

• Patients that have an American Society of Anesthesiologists physical status ≥4 (severe, life-threatening disease).

• Infants born more than 4 weeks premature.

Exclusion Criteria (MRI with general anesthesia: peripheral blood patients; anesthesia but no surgery):

• Known central nervous system disease.

• Treatment in the last 48 hours with non-steroidal anti-inflammatory (NSAID) or corticosteroid medications.

• Treatment with any drug known to induce or suppress inflammation.

• Patients that have an American Society of Anesthesiologists (ASA) physical status ≥4 (severe, life-threatening disease).

• Infants born more than 4 weeks premature.