Cerebral Oximetry With Near-infrared Spectroscopy and Negative Postoperative Behavioral Changes in Pediatric Surgery
- Conditions
- Cognitive Dysfunction
- Registration Number
- NCT02773186
- Lead Sponsor
- Hospital Clínico Universitario de Valladolid
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 198
- Patients aged between 2 and 12 years undergoing major surgery using general anesthesia.
- Children aged below 2 or over 12.
- Neuropsychiatric disorder, or undergoing an emergency surgery.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of Negative Postoperative Behavioral Changes on 7th and 28th postoperative days NPOBC was measured by using thePost-Hospital Behaviour Questionnaire.
- Secondary Outcome Measures
Name Time Method Number of children with cerebral desaturation and NPOBC on 7th and 28th postoperative days Cerebral oxygen saturation was monitoring by using the monitor INVOS 5100