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Completed

NCT Number: NCT02773186

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

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.

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Key information

Conditions

Cognitive Dysfunction Cognition Disorders Mental Disorders Neurocognitive Disorders

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

monitoring cerebral oxygen saturation

Other

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).

Primary outcomes

  1. Incidence of Negative Postoperative Behavioral Changes

    Time frame: on 7th and 28th postoperative days

    NPOBC was measured by using thePost-Hospital Behaviour Questionnaire.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Hospital Clínico Universitario de Valladolid

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
May 16, 2016
Registry last updated
May 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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