Upper Respiratory InfectionsPhase 4NCT00611195
Remifentanil and Laryngeal Reflex Responses in Pediatric Patients With URI
A Phase 4 study testing propofol, remifentanil in people with Upper Respiratory Infections, run by Thomas Erb at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 84 months
- Conditions the study is for
- Upper Respiratory Infections
- What is being tested?
- propofol, remifentanil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2008to Dec 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 84 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA I + II
- elective intervention under general anesthesia
- acute upper respiratory tract infection
Who cannot join
- chronic respiratory tract infection
- fever >38,3° celsius
- productive cough
- neuromuscular disease
- malignant hyperthermia
- cardiac disease
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Upper Respiratory Infections
- Being tested
- propofol, remifentanil
- Keywords
- Anesthesia, Children, Larynx
- Medical subject headings
- Respiratory Tract Infections, Laryngeal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofol, remifentanilDrug
Also called Recofol, Disoprivan, Ultiva
propofol 3micrgr/ml (TCI plasma concentration Kataria model) versus propofol 3micrgr/ml and remifentanil 0.05microgr/kg/min
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Larynx assessment under stimulation Receives: Drug: propofol, remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of laryngospasm (defined as complete closure of the vocal or false cords with apnea lasting >10sec) after laryngeal stimulation
Measured: 5min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionOct 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Upper Respiratory InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Erb
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Thomas Erb, University Hospital, Basel, Switzerland
- Investigators
- Thomas O Erb, MD, Principal investigator, Universitiy children's hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00611195
- Sponsor's protocol ID
- UNIBAS:UKBB_ANE_LR5
- Other IDs
- SNF3200B0-109322
- Status last verified
- Oct 2015
- First submitted
- 25 Jan 2008
- Last updated
- 30 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16306725
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Remifentanil Administration on Laryngeal Reflex Responses in Pediatric Patients With Upper Respiratory Anesthetized With Propofol
- ClinicalTrials.gov ID
- NCT00611195
- Acronym / sponsor ID
- UNIBAS:UKBB_ANE_LR5
- Conditions
- Upper Respiratory Infections
- Keywords
- Anesthesia, Children, Larynx
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Thomas ErbUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Oct 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 8 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: propofol, remifentanilLarynx assessment under stimulation |
Who may qualify
- Ages
- 25 to 84 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ASA I + II
- elective intervention under general anesthesia
- acute upper respiratory tract infection
Key exclusion criteria (6 listed)
- chronic respiratory tract infection
- fever >38,3° celsius
- productive cough
- neuromuscular disease
- malignant hyperthermia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| propofol, remifentanilAlso: Recofol, Disoprivan, Ultivapropofol 3micrgr/ml (TCI plasma concentration Kataria model) versus propofol 3micrgr/ml and remifentanil 0.05microgr/kg/min | Drug | 1 |
Primary outcome
Occurence of laryngospasm (defined as complete closure of the vocal or false cords with apnea lasting >10sec) after laryngeal stimulation
Time frame: 5min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2015.
- Background: PubMed 16306725Oberer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas O Erb, MD principal investigator
Universitiy children's hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing propofol, remifentanil in people with Upper Respiratory Infections, run by Thomas Erb at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00611195, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2015.