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

J

Joseph D. Tobias

Status

Completed

Conditions

Infants Undergoing Surgery

Treatments

Device: NIRS

Study type

Interventional

Funder types

Other

Identifiers

NCT02840253
IRB16-00465

Details and patient eligibility

About

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.

Enrollment

23 patients

Sex

All

Ages

Under 12 months old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • All patients that are candidates for and have agreed to spinal anesthesia.

Exclusion criteria

  • none

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

23 participants in 1 patient group

NIRS
Experimental group
Description:
Non-invasive near infrared spectroscopy to assess changes in tissue and cerebral oxygenation.
Treatment:
Device: NIRS

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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