Remifentanil and Laryngeal Reflex Responses in Pediatric Patients With URI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00611195
Recruitment Status : Completed
First Posted : February 8, 2008
Last Update Posted : October 30, 2015
Information provided by (Responsible Party):
Thomas Erb, University Hospital, Basel, Switzerland

Brief Summary:

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.


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.

Condition or disease Intervention/treatment Phase
Upper Respiratory Infections Drug: propofol, remifentanil Phase 4

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of Remifentanil Administration on Laryngeal Reflex Responses in Pediatric Patients With Upper Respiratory Anesthetized With Propofol
Study Start Date : January 2008
Actual Primary Completion Date : October 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Larynx assessment under stimulation
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

Primary Outcome Measures :
  1. Occurence of laryngospasm (defined as complete closure of the vocal or false cords with apnea lasting >10sec) after laryngeal stimulation [ Time Frame: 5min ]

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Ages Eligible for Study:   25 Months to 84 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00611195

University children's hospital
Basel, Switzerland, 4058
Sponsors and Collaborators
Thomas Erb
Principal Investigator: Thomas O Erb, MD Universitiy children's hospital Basel

Responsible Party: Thomas Erb, Prof.Dr. Thomas Erb, University Hospital, Basel, Switzerland Identifier: NCT00611195     History of Changes
Other Study ID Numbers: UNIBAS:UKBB_ANE_LR5
SNF3200B0-109322 ( Other Identifier: SNF 3200B0-109322 )
First Posted: February 8, 2008    Key Record Dates
Last Update Posted: October 30, 2015
Last Verified: October 2015

Keywords provided by Thomas Erb, University Hospital, Basel, Switzerland:

Additional relevant MeSH terms:
Respiratory Tract Infections
Respiratory Tract Diseases
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Sensory System Agents
Peripheral Nervous System Agents