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Cerebral Oximetry With Near-infrared Spectroscopy and Negative Postoperative Behavioral Changes in Pediatric Surgery

Cerebral Oximetry With Near-infrared Spectroscopy and Negative Postoperative Behavioral Changes in Pediatric Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02773186
Enrollment
198
Registered
2016-05-16
Start date
2012-12-31
Completion date
2014-03-31
Last updated
2016-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Dysfunction

Keywords

postoperative, behavioral changes

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.

Detailed description

This prospective and observational study involved consecutive patients aged between 2 and 12 years undergoing a major surgery using general anesthesia. Cerebral oxygen saturation, non-invasive arterial pressure, pulse oximetry, and heart rate were recorded at the following stages of the surgical intervention: baseline, induction, intubation, surgical incision, end of surgery, and extubation. Preoperative anxiety was evaluated by using the modified Yale Preoperative Anxiety Scale, and NPOBC was determined by using the Post-Hospital Behaviour Questionnaire on 7th and 28th postoperative days. A logistic regression was created to identify factors associated with the development of NPOBC

Interventions

OTHERmonitoring 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).

Sponsors

Hospital Clínico Universitario de Valladolid
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Negative Postoperative Behavioral Changeson 7th and 28th postoperative daysNPOBC was measured by using thePost-Hospital Behaviour Questionnaire.

Secondary

MeasureTime frameDescription
Number of children with cerebral desaturation and NPOBCon 7th and 28th postoperative daysCerebral oxygen saturation was monitoring by using the monitor INVOS 5100

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026