Laryngospasm Clinical Trial
Official title:
Impact of Intravenous Lidocaine on Laryngeal Reflex Responses in Pediatric Patients Anesthetized With Propofol
To describe respiratory and laryngeal responses to laryngeal stimulation during propofol
anesthesia in children. To determine whether the co-administration of lidocaine blunts these
reflex responses. The outcome of primary interest is the reflex laryngospasm.
Hypotheses:
I: The severity of laryngospasm evoked by laryngeal stimulation is reduced 2 min. after iv.
administration on 2mg/kg lidocaine in pediatric patients anesthetized with propofol
(3mcg/ml).
II:The incidence of laryngospasm elicited by controlled stimulation 10min. after iv.
administration of lidocaine is equivalent to the response before the administration of
lidocaine.
Based on our previous work assessing the laryngeal reflex responses in children, the use of
propofol appears to be promising regarding a low incidence of laryngospasm. Compared with a
sevoflurane-based anesthesia, the incidence was found to be significantly lower, but there
is a high incidence of other reflex responses, such as coughing and expiration reflexes. The
use of lidocaine has been advocated to reduce the incidence of laryngospasm in anesthetized
children. However, based on clinical studies its effectiveness in the prevention or
attenuation of laryngospasm is controversial.
In a previous work using a established stimulation model (stimulating the laryngeal mucosa
with a small amount of distilled water under direct fiberbronchoscopic observation), we
observed a risk reduction of 60% of laryngospasm 2min. after the application of 2mg/kg bolus
of lidocaine. This effect had already diminished after 10 min.
The laryngeal reflex responses differ largely in children anesthetized with either
inhalational anesthetics or with propofol. The impact iv administered lidocaine on laryngeal
and respiratory reflex responses in children anesthetized with propofol has not been
assessed, although this combination might result in a profound suppression of laryngeal
reflex responses.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04159116 -
Prevention and Treatment of Laryngospasm and Hypoxemia Based on Risk Factors in Adult Outpatients Undergoing EGD
|
N/A | |
Active, not recruiting |
NCT01288248 -
Noninferiority Clinical Trial With Laryngeal Mask and Endotracheal Tube
|
Phase 3 | |
Terminated |
NCT01445847 -
The Effect of Intravenous Lidocaine on Post-extubation Laryngospasm
|
N/A | |
Terminated |
NCT00665418 -
Sevoflurane and Laryngeal Reflex Responses in Pediatric Patients
|
Phase 4 | |
Completed |
NCT00925613 -
Benefits of Exchanging a Double Lumen Tube to a Proseal Laryngeal Mask or a Single Lumen Tube After a Thoracic Surgery
|
Phase 3 |