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Growth and Intelligence Outcome in Children Who Developed Perioperative Desaturation

NCT01965093 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 104

Last updated 2013-10-18

No results posted yet for this study

Summary

The most serious peri-operative respiratory event (PRE) in pediatric anesthesia is desaturation or hypoxemia which could lead to cardiovascular collapse or cardiac arrest. Intermittent hypoxic episode especially in infants are also associated with impaired growth, longer-term cardiorespiratory instability and poor neurodevelopmental outcome.12 The mechanism of peri-operative desaturation occurring in normoxia infant brain is quite similar to overabundance of oxygen in the acutely hypoxic infant by using 100% oxygen or hyperoxia for resuscitation of acutely asphyxiated infants which can generate excessive neurotoxic compounds and increase oxidative stress markers.17 Anesthetic agents which involve gamma-aminobutyric acid (GABA)receptors eg; volatile agents, midazolam and N-methyl-D-aspartate receptor (NMDA) receptors eg; nitrous oxide, ketamine can cause neuronal apoptosis, neuronal necrosis, neuronal cell death and memory deficit in rat pups. Moreover, prolonged anesthetic exposure, irrespective of open heart surgery, can influence neurodevelopment of the brain in rodents.17 However, the evidence for anesthetic agents causing apoptosis and neurodegeneration in human neonatal brain is still not clear.

Thus, peri-operative desaturation occurred in young age regardless of severity combined with general anesthesia might possibly affect the long-term impact regarding growth and neurodevelopmental outcome in infant or intelligence outcome in older children. In our study, we are interested in looking at the intelligence outcome, which is a part of neurodevelopment outcome, in preschool children aged ≤ 5 years who developed desaturation peri-operatively. Because we include a wide range of age between newborn to five years old to test neurodevelopment outcome in older children, the intelligence outcome may be more appropriate and can be applied to infants and younger ages. Therefore, the objective of study was to compare intelligence outcome between children who developed peri-operative desaturation and children who did not develop PRE.

Conditions

  • Low IQ
  • Disorder of Growth and Development

Interventions

PROCEDURE

perioperative desaturation

children aged 0-5 years old who receive general anesthesia and developed perioperative desaturation

PROCEDURE

no perioperative desaturation

children aged 0-5 years who did not developed perioperative desaturation under general anesthesia

Sponsors & Collaborators

  • The Royal Golden Jubilee PhD funding of Thailand

    collaborator UNKNOWN

  • Prince of Songkla University

    lead OTHER

Principal Investigators

  • Maliwan Oofuvong, MD · Prince of Songkla University

Eligibility

Min Age
1 Day
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01965093 on ClinicalTrials.gov