Cerebral Oximetry With Near-infrared Spectroscopy and Negative Postoperative Behavioral Changes in Pediatric Surgery
1 other identifier
observational
198
0 countries
N/A
Brief Summary
The main objective of the present study was to evaluate whether cerebral oxygen saturation is associated with an increase of NPOBC in pediatric patients undergoing major surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2012
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 21, 2016
CompletedFirst Posted
Study publicly available on registry
May 16, 2016
CompletedMay 17, 2016
May 1, 2016
1.2 years
April 21, 2016
May 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Negative Postoperative Behavioral Changes
NPOBC was measured by using thePost-Hospital Behaviour Questionnaire.
on 7th and 28th postoperative days
Secondary Outcomes (1)
Number of children with cerebral desaturation and NPOBC
on 7th and 28th postoperative days
Interventions
Children undergoing urological surgery also required of locoregional blockade. Anesthetic induction was achieved with high concentration sevoflurane 6-8% (Sevorane®, Abbvie) and oxygen 50%. Anesthetic maintenance was done with sevoflurane 2-3%, 50% O2/air mixture, fentanyl 1 µg.kg.-1 iv, and rocuronium 0.3 µg.kg.-1 iv if required. Electrocardiogram (ECG), non-invasive arterial pressure, pulse oximetry, end-tidal carbon dioxide and cerebral NIRS oximetry was monitoring by using an INVOSTM5100 (Somanetics Corporation, Troy, MI, USA).
Eligibility Criteria
This prospective and observational study involved consecutive patients aged between 2 and 12 years undergoing a major surgery using general anesthesia.Children undergoing urological and general surgery also required of locoregional blockade. Anesthetic induction was achieved with high concentration sevoflurane 6-8% (Sevorane®, Abbvie) and oxygen 50%. Anesthetic maintenance was done with sevoflurane 2-3%, 50% O2/air mixture, fentanyl 1 µg.kg.-1 iv, and rocuronium 0.3 µg.kg.-1 iv if required. Electrocardiogram (ECG), non-invasive arterial pressure, pulse oximetry, end-tidal carbon dioxide and cerebral NIRS oximetry was monitoring by using an INVOSTM5100 (Somanetics Corporation, Troy, MI, USA)
You may qualify if:
- Patients aged between 2 and 12 years undergoing major surgery using general anesthesia.
You may not qualify if:
- Children aged below 2 or over 12.
- Neuropsychiatric disorder, or undergoing an emergency surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Eduardo Tamayo Gómez, MD PhD
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD Anesthesiologist
Study Record Dates
First Submitted
April 21, 2016
First Posted
May 16, 2016
Study Start
December 1, 2012
Primary Completion
March 1, 2014
Study Completion
March 1, 2014
Last Updated
May 17, 2016
Record last verified: 2016-05