EFFECTIVENESS OF INTRANASAL DEXMEDETOMIDINE FOR SEDATEDAUDITORY BRAINSTEM RESPONSE TESTING

Phase 1

• Conditions: Child requiring auditory evaluation in a context of suspicion of deafness, language delay, overall developmental delay, risk factors for hearing loss.; MedDRA version: 20.1Level: PTClassification code 10049507Term: Brain stem auditory evoked responseSystem Organ Class: 10022891 - Investigations; Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

• Registration Number: EUCTR2018-001466-42-FR
• Lead Sponsor: Fondation Lenval - Hôpitaux Pédiatriques de Nice CHULENVA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-19
• Last Update Posted: 29 November 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

-Child aged 1 to 15 years old
-ASA 1 or 2 (American Society Anesthesiologists scale patient)
-Need to evaluate the child audition in a context of suspicion of
deafness, delay of language, global delay of the development, the risk
factors of hearing loss
-Impossibility to realize a hearing test by conventional audiogram or
behavioral due to a cognitive or behavioral disorder of the child
-Affiliation to social security scheme
-Signature of the authorization documents of the 2 parents or the
representative of the parental authority for the participation of the child
in the study
Are the trial subjects under 18? yes
Number of subjects for this age range: 60
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Heart disease or heart rhythm disorder
- Pneumopathy or asthmatic crisis in previous 2 weeks in the
examination
- Recent used of digoxine or beta-blocker
- Use of anti-epileptic or psychotropic drugs
- Medical history of sleep apnea
- Receptor alpha2 agonist allergy
- Gastrooesophageal reflux disease
- Upper airway abnormality
- Acute cerebrovascular diseases
- Neurologic disorders ( cranial trauma and after neurosurgical
operation)
- Recent CVA
- Moyamoya disease
- General anesthesia planned for another procedure

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Estimate the effectiveness of intranasal dexmedetomidine in the<br>realization of the auditory brainstem response at the child with a<br>cognitive or behavioral disorder.;Secondary Objective: 1) Tolerance study of dexmedetomidine for sedated auditory branstem<br>response testing at the child<br>2) Evaluation of time to obtain of a correct sedation.<br>3) Evaluation of time to get a conscient wake up.;Primary end point(s): the rate of children included in the study who could determine the<br>auditory threshold. The non-determination of this threshold (or the<br>determination by resorting to general anesthesia or sedation of another<br>type) regardless of the cause will be considered a failure.;Timepoint(s) of evaluation of this end point: at the end of the realization of auditory brainstem response