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Completed

NCT Number: NCT00611195

Remifentanil and Laryngeal Reflex Responses in Pediatric Patients With URI

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.

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Key information

Age range

25 month–84 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University children's hospital

Basel, 4058, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

propofol, remifentanil

Drug

propofol 3micrgr/ml (TCI plasma concentration Kataria model) versus propofol 3micrgr/ml and remifentanil 0.05microgr/kg/min

Other names: Recofol, Disoprivan, Ultiva

Primary outcomes

  1. Occurence of laryngospasm (defined as complete closure of the vocal or false cords with apnea lasting >10sec) after laryngeal stimulation

    Time frame: 5min

Sponsors and collaborators

Lead sponsor

Thomas Erb

Other

Registry information

Official study title

Impact of Remifentanil Administration on Laryngeal Reflex Responses in Pediatric Patients With Upper Respiratory Anesthetized With Propofol

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Feb 8, 2008
Registry last updated
Oct 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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