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N/A N=23 Diagnostic

Changes in Tissue and Cerebral Oxygenation Following Spinal Anesthesia in Neonates, Infants, and Children

Infants Undergoing Surgery

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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