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Clinical Trials/NCT02773186
NCT02773186
Completed
Not Applicable

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

Hospital Clínico Universitario de Valladolid0 sites198 target enrollmentDecember 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cognitive Dysfunction
Sponsor
Hospital Clínico Universitario de Valladolid
Enrollment
198
Primary Endpoint
Incidence of Negative Postoperative Behavioral Changes
Status
Completed
Last Updated
9 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
December 2012
End Date
March 2014
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Estefanía Gomez Pesquera

MD Anesthesiologist

Hospital Clínico Universitario de Valladolid

Eligibility Criteria

Inclusion Criteria

  • Patients aged between 2 and 12 years undergoing major surgery using general anesthesia.

Exclusion Criteria

  • Children aged below 2 or over
  • Neuropsychiatric disorder, or undergoing an emergency surgery.

Outcomes

Primary Outcomes

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

  • Number of children with cerebral desaturation and NPOBC(on 7th and 28th postoperative days)

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