Trial Outcomes & Findings for Isoflurane-induced Neuroinflammation in Children With Hydrocephalus (NCT NCT02512809)
NCT ID: NCT02512809
Last Updated: 2018-12-13
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
25 participants
Primary outcome timeframe
On the day of surgery or MRI from start of procedure to discharge from PACU (approx. 1-7 hrs.)
Results posted on
2018-12-13
Participant Flow
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.
Participant milestones
| Measure |
MRI Control Arm
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 Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Isoflurane-induced Neuroinflammation in Children With Hydrocephalus
Baseline characteristics by cohort
| Measure |
Isoflurane Arm
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
|
Dexmedetomidine/Remifentanil Arm
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
|
MRI Control Arm
n=25 Participants
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
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
25 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Continuous
|
—
|
—
|
3.73 years
STANDARD_DEVIATION 2.49 • n=27 Participants
|
3.73 years
STANDARD_DEVIATION 2.49 • n=483 Participants
|
|
Sex: Female, Male
Female
|
—
|
—
|
10 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
—
|
—
|
15 Participants
n=27 Participants
|
15 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
—
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
—
|
—
|
3 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
—
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
—
|
—
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
—
|
—
|
21 Participants
n=27 Participants
|
21 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
—
|
—
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
—
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Weight
|
—
|
—
|
17.4 kilograms
STANDARD_DEVIATION 8.3 • n=27 Participants
|
17.4 kilograms
STANDARD_DEVIATION 8.3 • n=483 Participants
|
|
Anesthetic Time
|
—
|
—
|
54.7 minutes
STANDARD_DEVIATION 24.7 • n=27 Participants
|
54.7 minutes
STANDARD_DEVIATION 24.7 • n=483 Participants
|
|
Previous Anesthesia
Yes
|
—
|
—
|
12 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
|
Previous Anesthesia
No
|
—
|
—
|
13 Participants
n=27 Participants
|
13 Participants
n=483 Participants
|
|
American Society of Anesthesiologists (ASA) Physical Status classification
ASA 1
|
—
|
—
|
8 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
|
American Society of Anesthesiologists (ASA) Physical Status classification
ASA 2
|
—
|
—
|
17 Participants
n=27 Participants
|
17 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: On the day of surgery or MRI from start of procedure to discharge from PACU (approx. 1-7 hrs.)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.
Outcome measures
| Measure |
MRI Control Arm
n=25 Participants
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.
|
|---|---|
|
Change in Serum Cytokine Levels
IL-1β pre-isoflurane
|
25.97 pg/ml
Standard Deviation 9.01
|
|
Change in Serum Cytokine Levels
IL-1β post-isoflurane
|
38.53 pg/ml
Standard Deviation 16.56
|
|
Change in Serum Cytokine Levels
TNF-α pre-isoflurane
|
94.26 pg/ml
Standard Deviation 18.07
|
|
Change in Serum Cytokine Levels
TNF-α post-isoflurane
|
85.84 pg/ml
Standard Deviation 12.12
|
|
Change in Serum Cytokine Levels
IL-6 pre-isoflurane
|
2.28 pg/ml
Standard Deviation 2.27
|
|
Change in Serum Cytokine Levels
IL-6 post-isoflurane
|
2.04 pg/ml
Standard Deviation 2.15
|
Adverse Events
MRI Control Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place