Cerebral Oximetry With Near-infrared Spectroscopy and Negative Postoperative Behavioral Changes in Pediatric Surgery
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ClinicalTrials.gov Identifier: NCT02773186 |
Recruitment Status :
Completed
First Posted : May 16, 2016
Last Update Posted : May 17, 2016
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Condition or disease | Intervention/treatment |
---|---|
Cognitive Dysfunction | Other: monitoring cerebral oxygen saturation |
Study Type : | Observational |
Actual Enrollment : | 198 participants |
Time Perspective: | Prospective |
Official Title: | Cerebral Oximetry With Near-infrared Spectroscopy and Negative Postoperative Behavioral Changes in Pediatric Surgery |
Study Start Date : | December 2012 |
Actual Primary Completion Date : | March 2014 |
Actual Study Completion Date : | March 2014 |
- Other: monitoring cerebral oxygen saturation
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).
- Incidence of Negative Postoperative Behavioral Changes [ Time Frame: on 7th and 28th postoperative days ]NPOBC was measured by using thePost-Hospital Behaviour Questionnaire.
- Number of children with cerebral desaturation and NPOBC [ Time Frame: on 7th and 28th postoperative days ]Cerebral oxygen saturation was monitoring by using the monitor INVOS 5100

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Ages Eligible for Study: | 2 Years to 12 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Patients aged between 2 and 12 years undergoing major surgery using general anesthesia.
Exclusion Criteria:
- Children aged below 2 or over 12.
- Neuropsychiatric disorder, or undergoing an emergency surgery.

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): NCT02773186
Study Director: | Eduardo Tamayo Gómez, MD PhD |
Responsible Party: | Estefanía Gomez Pesquera, MD Anesthesiologist, Hospital Clínico Universitario de Valladolid |
ClinicalTrials.gov Identifier: | NCT02773186 |
Other Study ID Numbers: |
NPOBC |
First Posted: | May 16, 2016 Key Record Dates |
Last Update Posted: | May 17, 2016 |
Last Verified: | May 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | there is not plan by the moment |
postoperative behavioral changes |
Cognitive Dysfunction Problem Behavior Cognition Disorders |
Neurocognitive Disorders Mental Disorders Behavioral Symptoms |