Upper Respiratory Infections Clinical Trial
Official title:
Impact of Remifentanil Administration on Laryngeal Reflex Responses in Pediatric Patients With Upper Respiratory Anesthetized With Propofol
To describe respiratory and laryngeal responses to laryngeal stimulation during propofol
anesthesia in children with upper airway infections. To determine whether the
co-administration of remifentanil blunts these reflex responses. To test whether the
co-administration of remifentanil results in a significant reduction of apnea with
laryngospasm in these patients.
Hypotheses:
I: In children with a URI undergoing anesthesia with propofol, the incidence of apnea and
laryngospasm after controlled stimulation is expected to occur 2.5 times more frequently
than in children without URI (20 vs. 8%).
II: The incidence of apnea and laryngospasm is diminished after administration of
remifentanil.
Patients undergoing anesthesia in the presence of an upper respiratory infection (URI) are
very common in pediatric anesthesia practice. Although, clinical data confirm that children
with URIs are at increased risk of perioperative complications, it has become standard
practice not to postpone anesthesia in the presence of URI. While complications (such as
cough, hypoxemia) can be anticipated, recognized, and treated, laryngospasm remains the most
severe and dramatic complication. In clinical practice, patients who develop laryngospasm
are greater than 2.5 times more likely to have an active upper respiratory infection;
therefore, knowledge that allows for rational selections of anesthetic agents under this
condition is highly warranted. Based on our results obtained in healthy children, the use of
propofol appears to be most promising under these circumstances. For this reason, the
laryngeal and respiratory reflex responses should be assessed in patients with URI
anaesthetized with propofol.
Commonly held believes suggest, that the administration of opioids blunts airway reflexes,
including laryngospasm. However, in a previous study of our group in children anesthetized
with sevoflurane the administration of fentanyl effectively blunted all airway reflexes but
laryngospasm. These results are in contrast to those obtained in adults anesthetized with
propofol where fentanyl also effectively blunted laryngospasm.
In children the combined use of propofol and remifentanil has become more frequent,
particularly because of its synergistic pharmacodynamic effect. Besides its use during
surgical procedures, this regime is also being increasingly advocated for diagnostic
procedures such as bronchoscopy and esophago-gastroduodenoscopy. These interventions include
instrumentation of the airway in children that are at an increased risk of harmful effects
of laryngeal reflex responses.
Despite their obvious clinical significance, reflexes that involve the function of the upper
airway are only minimally understood and information on such reflexes is scarce in
anesthetized humans. Nonetheless, a model was developed by analyzing respiratory variables
and endoscopic images after stimulating the laryngeal mucosa with a small amount of
distilled water. This model was successfully adapted to the pediatric setting by our group
assessing the impact of propofol, sevoflurane, fentanyl and lidocaine administration on
laryngeal reflex responses in preschool children.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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