Isoflurane-induced Neuroinflammation in Children With Hydrocephalus

NCT02512809 | Terminated Phase 3 Results DMC

• 1 other identifier: IRB14-00625
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Toxicity; Hydrocephalus

Outcome Measures

Primary Outcomes (1)

• Change in Serum Cytokine Levels

  Surgery subjects will have blood collected once at the start of surgery, once at the end of surgery, and once in the PACU. MRI patients will have blood collected once prior to the start of the MRI and once at the completion of the MRI.

  On the day of surgery or MRI from start of procedure to discharge from PACU (approx. 1-7 hrs.)

Study Arms (3)

Isoflurane Arm

EXPERIMENTAL

Pediatric patients, aged 0-5 years, diagnosed with hydrocephalus undergoing a surgical (non-bedside) shunting procedure with general anesthesia. Pts will receive a standardized general anesthetic with isoflurane.

Drug: Isoflurane

Dexmedetomidine/remifentanil Arm

EXPERIMENTAL

Pediatric patients, aged 0-5 years, diagnosed with hydrocephalus undergoing a surgical (non-bedside) shunting procedure with general anesthesia. Pts will receive a standardized general anesthetic with dexmedetomidine and remifentanil infusions..

Drug: Dexmedetomidine

MRI Control Arm

NO INTERVENTION

Otherwise healthy pediatric patients, aged 0-5 years, undergoing MRI with general anesthesia for evaluation of non-neurologic disease. Patients will receive a standardized general anesthetic with isoflurane.

Interventions

Isoflurane DRUG

Also known as: Isosthesia, Forane

Isoflurane Arm

Dexmedetomidine DRUG

Also known as: Precedex

Dexmedetomidine/remifentanil Arm

Eligibility Criteria

• Age: 1 Day - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Nationwide Children's Hospital: lead
• Ohio State University: collaborator

MeSH Terms

Conditions

Hydrocephalus

Interventions

Isoflurane; Dexmedetomidine

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Joseph D. Tobias, MD
• Organization: Nationwide Children's Hospital

joseph.tobias@nationwidechildrens.org

6147224200

Study Officials

• Joseph Tobias, M.D.

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of Anesthesiology & Pain Medicine

Study Record Dates

• First Submitted: February 23, 2015
• First Posted: July 31, 2015
• Study Start: July 1, 2015
• Primary Completion: October 31, 2017
• Study Completion: October 31, 2017
• Last Updated: December 13, 2018
• Results First Posted: December 13, 2018

Record last verified: 2018-12