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

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ClinicalTrials.gov Identifier: NCT02773186
Recruitment Status : Completed
First Posted : May 16, 2016
Last Update Posted : May 17, 2016
Sponsor:
Information provided by (Responsible Party):
Estefanía Gomez Pesquera, Hospital Clínico Universitario de Valladolid

Study Description
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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.

Condition or disease Intervention/treatment
Cognitive Dysfunction Other: monitoring cerebral oxygen saturation

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
Study Design
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Study Type : Observational
Actual Enrollment : 198 participants
Time Perspective: Prospective
Official Title: Cerebral Oximetry With Near-infrared Spectroscopy and Negative Postoperative Behavioral Changes in Pediatric Surgery
Study Start Date : December 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014
Groups and Cohorts
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Intervention Details:
  • 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).

Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This prospective and observational study involved consecutive patients aged between 2 and 12 years undergoing a major surgery using general anesthesia.Children undergoing urological and general 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)
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02773186


Sponsors and Collaborators
Hospital Clínico Universitario de Valladolid
Investigators
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Study Director: Eduardo Tamayo Gómez, MD PhD
More Information
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Additional Information:

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Responsible Party: Estefanía Gomez Pesquera, MD Anesthesiologist, Hospital Clínico Universitario de Valladolid
ClinicalTrials.gov Identifier: NCT02773186    
Other Study ID Numbers: NPOBC
First Posted: May 16, 2016    Key Record Dates
Last Update Posted: May 17, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: there is not plan by the moment
Keywords provided by Estefanía Gomez Pesquera, Hospital Clínico Universitario de Valladolid:
postoperative
behavioral changes
Additional relevant MeSH terms:
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Cognitive Dysfunction
Problem Behavior
Cognition Disorders
 Neurocognitive Disorders
Mental Disorders
Behavioral Symptoms