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

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ClinicalTrials.gov Identifier: NCT02840253
Recruitment Status : Completed
First Posted : July 21, 2016
Results First Posted : August 16, 2018
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
Joseph D. Tobias, Nationwide Children's Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Infants Undergoing Surgery Device: NIRS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Actual Study Start Date : July 2016
Actual Primary Completion Date : May 12, 2017
Actual Study Completion Date : May 12, 2017

Arm Intervention/treatment
Experimental: NIRS
Non-invasive near infrared spectroscopy to assess changes in tissue and cerebral oxygenation.
Device: NIRS



Primary Outcome Measures :
  1. Cerebral Non-invasive Near Infrared Spectroscopy (NIRS) [ Time Frame: Intraoperative measure ]
    Change in cerebral oxygen saturation from immediately after spinal anesthesia placement to conclusion of monitoring (30 mins post block).

  2. Tissue Non-invasive Near Infrared Spectroscopy (NIRS) [ Time Frame: Intraoperative measure ]
    Change in tissue oxygen saturation from immediately after spinal anesthesia placement to conclusion of monitoring (30 mins post block).



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Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02840253


Sponsors and Collaborators
Joseph D. Tobias
Investigators
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Principal Investigator: Joseph Tobias, MD Nationwide Children's Hospital
  Study Documents (Full-Text)

Documents provided by Joseph D. Tobias, Nationwide Children's Hospital:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Joseph D. Tobias, Chairman, Dept. of Anesthesiology & Pain Medicine, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT02840253    
Other Study ID Numbers: IRB16-00465
First Posted: July 21, 2016    Key Record Dates
Results First Posted: August 16, 2018
Last Update Posted: August 16, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No