Remifentanil and Laryngeal Reflex Responses in Pediatric Patients With URI

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thomas Erb, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00611195
First received: January 25, 2008
Last updated: March 12, 2013
Last verified: March 2013

January 25, 2008
March 12, 2013
January 2008
October 2012   (final data collection date for primary outcome measure)
Occurence of laryngospasm (defined as complete closure of the vocal or false cords with apnea lasting >10sec) after laryngeal stimulation [ Time Frame: 5min ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00611195 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Remifentanil and Laryngeal Reflex Responses in Pediatric Patients With URI
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.

Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Upper Respiratory Infections
Drug: propofol, remifentanil
propofol 3micrgr/ml (TCI plasma concentration Kataria model) versus propofol 3micrgr/ml and remifentanil 0.05microgr/kg/min
Other Names:
  • Recofol
  • Disoprivan
  • Ultiva
1
Larynx assessment under stimulation
Intervention: Drug: propofol, remifentanil
Oberer C, von Ungern-Sternberg BS, Frei FJ, Erb TO. Respiratory reflex responses of the larynx differ between sevoflurane and propofol in pediatric patients. Anesthesiology. 2005 Dec;103(6):1142-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
62
December 2012
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • ASA I + II
  • elective intervention under general anesthesia
  • acute upper respiratory tract infection

Exclusion Criteria:

  • chronic respiratory tract infection
  • fever >38,3° celsius
  • productive cough
  • neuromuscular disease
  • malignant hyperthermia
  • cardiac disease
Both
25 Months to 84 Months
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00611195
UNIBAS:UKBB_ANE_LR5, SNF3200B0-109322
No
Thomas Erb, University Hospital, Basel, Switzerland
Thomas Erb
Not Provided
Principal Investigator: Thomas O Erb, MD Universitiy children's hospital Basel
University Hospital, Basel, Switzerland
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP