Cerebral Oximetry With Near-infrared Spectroscopy and Negative Postoperative Behavioral Changes in Pediatric Surgery
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| ClinicalTrials.gov Identifier: NCT02773186 |
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Recruitment Status :
Completed
First Posted : May 16, 2016
Last Update Posted : May 17, 2016
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Sponsor:
Hospital Clínico Universitario de Valladolid
Information provided by (Responsible Party):
Estefanía Gomez Pesquera, Hospital Clínico Universitario de Valladolid
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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 |
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 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 |
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).
Primary Outcome Measures :
- 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 :
- 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
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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.
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
| Study Director: | Eduardo Tamayo Gómez, MD PhD |
Additional Information:
| 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:
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postoperative behavioral changes |
Additional relevant MeSH terms:
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Cognitive Dysfunction Problem Behavior Cognition Disorders |
Neurocognitive Disorders Mental Disorders Behavioral Symptoms |