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Remifentanil and Laryngeal Reflex Responses in Pediatric Patients With URI

Primary Purpose

Upper Respiratory Infections

Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
propofol, remifentanil
Sponsored by
Thomas Erb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Upper Respiratory Infections focused on measuring Anesthesia, Children, Larynx

Eligibility Criteria

25 Months - 84 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University children's hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1

Arm Description

Larynx assessment under stimulation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 25, 2008
Last Updated
October 29, 2015
Sponsor
Thomas Erb
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1. Study Identification

Unique Protocol Identification Number
NCT00611195
Brief Title
Remifentanil and Laryngeal Reflex Responses in Pediatric Patients With URI
Official Title
Impact of Remifentanil Administration on Laryngeal Reflex Responses in Pediatric Patients With Upper Respiratory Anesthetized With Propofol
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Thomas Erb

4. Oversight

Data Monitoring Committee
No

5. Study Description

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. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Respiratory Infections
Keywords
Anesthesia, Children, Larynx

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
Larynx assessment under stimulation
Intervention Type
Drug
Intervention Name(s)
propofol, remifentanil
Other Intervention Name(s)
Recofol, Disoprivan, Ultiva
Intervention Description
propofol 3micrgr/ml (TCI plasma concentration Kataria model) versus propofol 3micrgr/ml and remifentanil 0.05microgr/kg/min
Primary Outcome Measure Information:
Title
Occurence of laryngospasm (defined as complete closure of the vocal or false cords with apnea lasting >10sec) after laryngeal stimulation
Time Frame
5min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Months
Maximum Age & Unit of Time
84 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas O Erb, MD
Organizational Affiliation
Universitiy children's hospital Basel
Official's Role
Principal Investigator
Facility Information:
Facility Name
University children's hospital
City
Basel
ZIP/Postal Code
4058
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
16306725
Citation
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. doi: 10.1097/00000542-200512000-00007.
Results Reference
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Remifentanil and Laryngeal Reflex Responses in Pediatric Patients With URI

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