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

Cognitive Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02773186
• Other study ID #: NPOBC
• Status: Completed
• Phase: N/A
• First received: April 21, 2016
• Last updated: May 13, 2016
• Start date: December 2012
• Est. completion date: March 2014

Study information

• Verified date: May 2016
• Source: Hospital Clínico Universitario de Valladolid
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 12 Years

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Dysfunction
• Problem Behavior

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clínico Universitario de Valladolid

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Negative Postoperative Behavioral Changes	NPOBC was measured by using thePost-Hospital Behaviour Questionnaire.	on 7th and 28th postoperative days	No
Secondary	Number of children with cerebral desaturation and NPOBC	Cerebral oxygen saturation was monitoring by using the monitor INVOS 5100	on 7th and 28th postoperative days	No

External Links

•   The INVOS™ system provides real-time monitoring of changes in regional oxygen saturation (rSO2) of blood in the brain or other body tissues beneath the sensor for effective oxygen monitoring in adults, children, infants and neonates.