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Trial record 1 of 2 for:    "Congenital Hydrocephalus" | "Analgesics, Non-Narcotic"
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Isoflurane-induced Neuroinflammation in Children With Hydrocephalus

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ClinicalTrials.gov Identifier: NCT02512809
Recruitment Status : Terminated (PI moving to another institution.)
First Posted : July 31, 2015
Results First Posted : December 13, 2018
Last Update Posted : December 13, 2018
Sponsor:
Collaborator:
Ohio State University
Information provided by (Responsible Party):
Joseph D. Tobias, Nationwide Children's Hospital

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Toxicity
Hydrocephalus
Interventions Drug: Isoflurane
Drug: Dexmedetomidine
Enrollment 25
Recruitment Details  
Pre-assignment Details There were no participants assigned to the "Isoflurane" and "Dexmedetomidine/Remifentanil Arm" Arms/Groups as only the MRI control arm completed enrollment prior to the original PI leaving the institution and there was no enrollment in the other 2 arms.
Arm/Group Title MRI Control Arm
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 25
Completed 25
Not Completed 0
Arm/Group Title Isoflurane Arm Dexmedetomidine/Remifentanil Arm MRI Control Arm Total
Hide Arm/Group Description

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.

Isoflurane

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..

Dexmedetomidine

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. Total of all reporting groups
Overall Number of Baseline Participants 0 0 25 25
Hide Baseline Analysis Population Description
Only the MRI control arm completed enrollment prior to the original PI leaving the institution. There was no enrollment in the other 2 arms.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 25 participants 25 participants
<=18 years 0 0
25
 100.0%
25
 100.0%
Between 18 and 65 years 0 0
0
   0.0%
0
   0.0%
>=65 years 0 0
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 0 participants 0 participants 25 participants 25 participants
3.73  (2.49) 3.73  (2.49)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 25 participants 25 participants
Female
10
  40.0%
10
  40.0%
Male
15
  60.0%
15
  60.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 25 participants 25 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
Asian
3
  12.0%
3
  12.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
Black or African American
1
   4.0%
1
   4.0%
White
21
  84.0%
21
  84.0%
More than one race
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 0 participants 0 participants 25 participants 25 participants
17.4  (8.3) 17.4  (8.3)
Anesthetic Time  
Mean (Standard Deviation)
Unit of measure:  Minutes
Number Analyzed 0 participants 0 participants 25 participants 25 participants
54.7  (24.7) 54.7  (24.7)
Previous Anesthesia  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 25 participants 25 participants
Yes
12
  48.0%
12
  48.0%
No
13
  52.0%
13
  52.0%
American Society of Anesthesiologists (ASA) Physical Status classification   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 25 participants 25 participants
ASA 1
8
  32.0%
8
  32.0%
ASA 2
17
  68.0%
17
  68.0%
[1]
Measure Description:

ASA 1: Normal healthy patient

ASA 2: Patients with mild systemic disease

ASA 3: Patients with severe systemic disease

ASA 4: Patients with severe systemic disease that is a constant threat to life

ASA 5: Moribund patients who are not expected to survive without the operation

ASA 6: A declared brain-dead patient whose organs are being removed for donor purposes

1.Primary Outcome
Title Change in Serum Cytokine Levels
Hide Description 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.
Time Frame On the day of surgery or MRI from start of procedure to discharge from PACU (approx. 1-7 hrs.)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MRI Control Arm
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: pg/ml
IL-1β pre-isoflurane 25.97  (9.01)
IL-1β post-isoflurane 38.53  (16.56)
TNF-α pre-isoflurane 94.26  (18.07)
TNF-α post-isoflurane 85.84  (12.12)
IL-6 pre-isoflurane 2.28  (2.27)
IL-6 post-isoflurane 2.04  (2.15)
Time Frame 1 day
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MRI Control Arm
Hide Arm/Group Description 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.
All-Cause Mortality
MRI Control Arm
Affected / at Risk (%)
Total   0/25 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
MRI Control Arm
Affected / at Risk (%)
Total   0/25 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
MRI Control Arm
Affected / at Risk (%)
Total   0/25 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Joseph D. Tobias, MD
Organization: Nationwide Children's Hospital
Phone: 6147224200
EMail: joseph.tobias@nationwidechildrens.org
Layout table for additonal information
Responsible Party: Joseph D. Tobias, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT02512809     History of Changes
Other Study ID Numbers: IRB14-00625
First Submitted: February 23, 2015
First Posted: July 31, 2015
Results First Submitted: November 19, 2018
Results First Posted: December 13, 2018
Last Update Posted: December 13, 2018