Changes in Tissue and Cerebral Oxygenation Following Spinal Anesthesia in Neonates, Infants, and Children
Phase: NA
Conditions: Infants Undergoing Surgery
Sponsor: Joseph D. Tobias

 
 
 
Changes in tissue and cerebral oxygenation following spinal anesthesia 
in neonates, infants, and children 
 
NCT02840253  
 
IRB Approval Date:  6/14/2016  
 

Title:  Changes in tissue and cerebral oxygenation following spinal anesthesia in 
neonates, infants, and children 
 
Investigators: 
1. Joseph D. Tobias, MD 
2. Emmett Whitaker, MD 
3. David Martin, MD 
 
Describe the background and rationale for this project. Reference to 
peer reviewed literature is desirable: Animal studies suggest that 
anesthesia may increase neuronal apoptosis in the neonatal and developing brain 
of the very young.1-3 Primate and retrospective cohort studies also indicate the 
possibility of long-term cognitive deficits as a side effect of anesthesia.4-6 The 
molecular pathways that could cause neurotoxic effects of anesthesia are 
currently not known. However, significantly increased apoptosis of neurons after 
anesthesia has been observed in animal studies with rodents and primates. To 
reduce the potential risk of neurological damage to the brain from anesthesia, 
there has been a resurgence in the use of spinal anesthesia instead of general 
anesthesia for specific surgery procedures involving the GU system, lower 
abdomen, and extremities.7   
 
In line with these concerns, we have started an awake spinal anesthesia 
program in conjunction with our pediatric surgical colleagues.  Patients are 
offered the option of awake spinal anesthesia instead of general anesthesia for 
appropriate surgical procedures.  Previous studies have demonstrated a lack of 
significant hemodynamic changes in neonates and infants following spinal 
anesthesia; however, there are limited data regarding its impact on tissue 
oxygenation.  The goal of the current study is to assess changes in tissue and 
cerebral oxygenation using non-invasive near infrared spectroscopy following 
spinal anesthesia. 
 
How will your study be funded (i.e., will you use departmental funds, 
submit a grant application, etc.): No funding is required. 
 
Provide a potential start date for your study to be included in the IRB 
application: 1 July 2016 
 
Describe the significance of the proposed research: Although generally 
safe and effective, this study will demonstrate that tissue and cerebral 
oxygenation are maintained during spinal anesthesia in the awake in infants.  
Tissue oxygenation will be assessed non-invasively using near infrared 
spectroscopy, a device that is commonly used in our operating rooms to assess 
cerebral and tissue oxygenation.8-10 
 
 

 
State the primary and secondary objectives of the study:  
1. To evaluate changes in tissue and cerebral oxygenation following spinal 
anesthesia in infants. 
 
If this research is hypothesis driven, succinctly state the hypothesis: 
There will be no clinically significant change in tissue and cerebral oxygenation 
after spinal anesthesia. 
 
Outline the major steps and methodologies in the clinical protocol.   
If necessary, include a description of any procedures being performed 
already for diagnostic or treatment  purposes.  Clearly differentiate 
between these procedures.  This prospective study will include 50 patients 
presenting for spinal anesthesia.  There will be no change in the anesthetic or 
perioperative care of these patients. All patients will receive spinal anesthesia per 
our routine clinical guidelines that have been established.  Tissue and cerebral 
oxygenation will be monitored using near infrared spectroscopy (NIRS).  The 
device is applied non-invasively like pulse oximetry to a muscle bed (thigh or 
upper arm) and the forehead to measure tissue oxygenation.  These devices are 
used routinely in the operating room and the cardiothoracic intensive care unit. 
These devices are routinely used in various high risk clinical scenarios. The use 
of NIRS during these cases is the only modification from standard clinical 
practice that will occur for the purpose of the study.  NIRS will be recorded every 
30 seconds for 2 minutes prior to spinal anesthesia and these values averaged as 
the baseline.  Following that NIRS will be recorded every 1 minute for 30 
minutes.  The following data will also be recorded: BP, HR, and oxygen 
saturation. 
  
Identify the variables to be measured and how they will be statistically 
evaluated: Changes in tissue and cerebral oxygenation before and the following 
the administration of blood will be evaluated using a paired t-test.  To determine 
if there are differences between autologous and allogeneic blood, a non-paired t-
test will be used. 
 
 
 
 

References:  
1. Valentim AM, Alves HC, Olsson IA, Antunes LM. The effects of depth of 
isoflurane anesthesia on the performance of mice in a simple spatial 
learning task. J Am Assoc Lab Anim Sci 2008;47:16-9.  
2. McAuliffe JJ, Loepke AW, Miles L, Joseph B, Hughes E, Vorhees CV. 
Desflurane, isoflurane, and sevoflurane provide limited neuroprotection 
against neonatal hypoxia-ischemia in a delayed preconditioning paradigm. 
Anesthesiology. 2009;111:533-46. 
3. Jevtovic-Todorovic V, Hartman RE, Izumi Y, Benshoff ND, Dikranian K, 
Zorumski CF, et al. Early exposure to common anesthetic agents causes 
widespread neurodegeneration in the developing rat brain and persistent 
learning deficits. J Neurosci 2003;23:876-82. 
4. Wilder RT, Flick RP, Sprung J, Katusic SK, Barbaresi WJ, Mickelson C, et 
al. Early exposure to anesthesia and learning disabilities in a population-
based birth cohort. Anesthesiology 2009;110:796-804.  
5. Radcliffe J, Bellinger DC. Learning disability in children as an outcome in 
anesthesia and analgesia research. Anesth Analg 2011;112:1262-4. 
6. Jevtovic-Todorovic V. Anesthesia and the developing brain: are we getting 
closer to understanding the truth? Curr Opin Anaesthesiol 2011;24:395-9. 
7. Frawley G, Bell G, Disma N, et al; General Anesthesia compared to Spinal 
anesthesia (GAS) Consortium. Predictors of failure of awake regional 
anesthesia for neonatal hernia repair: Data from the general anesthesia 
compared to spinal anesthesia study--comparing apnea and 
neurodevelopmental outcomes. Anesthesiology 2015;123:55-65. 
8. Tobias JD.  Assessment of cerebral oxygenation using near infrared 
spectroscopy during isovolemic hemodilution in pediatric patients.  J Clin 
Monitor Comput 2011;25:171-4. 
9. Sun JS, Elsey N, Tobias JD. Perioperative management of a patient with 
suspected cerebral vascular insufficiency: Utility of cerebral oxygenation 
monitoring using near infrared spectroscopy.  Pediatr Anesth Crit Care J 
2014;2:105-11. 
10. Tobias JD.  Cerebral oxygenation monitoring: near infrared spectroscopy.  
Expert Rev Med Devices 2006;3:235-43.