N/A
N=23
Changes in Tissue and Cerebral Oxygenation Following Spinal Anesthesia in Neonates, Infants, and Children
Infants Undergoing Surgery
Bottom Line
View on ClinicalTrials.gov: NCT02840253 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcome: Primary: Cerebral Non-invasive Near Infrared Spectroscopy (NIRS) — 0.05 percentage change per minute
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- NIRS (Device)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Joseph D. Tobias
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cerebral Non-invasive Near Infrared Spectroscopy (NIRS) |
0.05 | — |
| PRIMARY Tissue Non-invasive Near Infrared Spectroscopy (NIRS) |
0.04 | — |
Summary
Investigators have started an awake spinal anesthesia program in conjunction with 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.
Eligibility Criteria
Inclusion Criteria
- All patients that are candidates for and have agreed to spinal anesthesia.
Exclusion Criteria
- none
Data sourced from ClinicalTrials.gov (NCT02840253). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.