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Intranasal Dexmedetomidine for Sedated Hearing Testing

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03530371
Recruitment Status : Recruiting
First Posted : May 21, 2018
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
Fondation Lenval

Brief Summary:

Auditory brainstem response testing is necessary in children who are not able to be tested by classical audiogram, because of their age or an associated retarded psycho-motor development or behavioral and cognitive troubles.

This test needs a perfect immobility of the child, ideally being asleep. This situation is sometimes impossible to achieve in non-cooperative children.

Currently, in the Pediatric Hospital of Nice, the investigators have to do a general anesthesia to perform quality auditory response tests in this kind of patients.

The alternative to a general anesthesia would be a reliable sedative drug, allowing the performance of this diagnostic exam without the need of a hospitalization.

Dexmedetomidine is a sedative drug with an action on the α2 adrenergic receptors. It causes a rapid sedation, similar to the natural sleep and with minimal secondary effects. The possibility of an intranasal administration, avoids the pain and discomfort of a venous access insertion.


Condition or disease Intervention/treatment Phase
Auditory Brainstem Response Drug: Dexmedetomidine Hydrochloride Phase 3

Detailed Description:

Auditory brainstem response testing is necessary in children who are not able to be tested by classical audiogram, because of their age or an associated retarded psycho-motor development or behavioral and cognitive troubles.

This test needs a perfect immobility of the child, ideally being asleep. This situation is sometimes impossible to achieve in non-cooperative children.

Currently, in the Pediatric Hospital of Nice, the investigators have to do a general anesthesia to perform quality auditory response tests in this kind of patients.

The alternative to a general anesthesia would be a reliable sedative drug, allowing the performance of this diagnostic exam without the need of a hospitalization. An intranasal administration avoids the pain and discomfort of a venous access insertion.

Dexmedetomidine is a sedative drug with an action on the α2 adrenergic receptors. It causes a rapid sedation, similar to the natural sleep and with minimal secondary effects. The treatment will be administrated by intranasal way at a dosage of 2,5µg/ kg in a single administration under continuous cardiorespiratory monitoring for 2 hours..

The objective of this work is to evaluate the effectiveness of intranasal dexmedetomidine in the realization of the auditory brainstem response at the child with a cognitive or behavioral disorder

This study will consist of research involving non-randomized, monocentric prospective interventional for a duration of 30 months. Patients from 1 year of age and under 16 years, in context of suspicion of deafness will be included. In view of active queue of otorhinolaryngology service of Nice University Hospital and taking into account lost sight, the investigators can include 60 patients, to have a representative sample of concerned pediatric population.

The primary endpoint will be the rate of children included in the study who could determine the auditory threshold. The non-determination of this threshold (or the determination by resorting to general anesthesia or sedation of another type) regardless of the cause will be considered a failure.

Despite the lack of specific protocols, the applications of dexmedetomidine in children for many diagnostic procedures have been studied in the past few years.

Any prospective study about the efficacy of dexmedetomidine for auditory brainstem response testing has been yet conducted in children

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Effectiveness of Intranasal Dexmedetomidine for Sedated Auditory Brainstem Response Testing
Actual Study Start Date : May 2, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dexmedetomidine Hydrochloride
sedation of patients to perform auditory test
Drug: Dexmedetomidine Hydrochloride
intranasal administration of 2.5µg/kg of dexmedetomidine to fall asleep the patients
Other Name: sedated auditory brainstem response




Primary Outcome Measures :
  1. quality of diagnostic [ Time Frame: 5 minutes after the realization of auditory test ]
    measure the rate of children for who the auditory threshold is obtained with drug sedation condition.


Secondary Outcome Measures :
  1. tolerance of treatment [ Time Frame: from drug administration to 24 hours after administration of drug ]

    The tolerance will measure by the collection of the following undesirable effects:

    • hypotension, bradycardia: deviation of> 20% (systolic pressure for blood pressure) from the normal values defined for the age of the subject under waking conditions
    • hypertension: deviation of> 20% (systolic pressure for blood pressure) from the normal values defined for the age of the subject in waking conditions
    • decrease in oxygenation: decrease in oxygen saturation <90%

    These effects will determinate by cardiorespiratory monitoring during the examination. A routine home phone call on D1 will collect information about possible unexpected side effects.


  2. time of correct sedation [ Time Frame: from 5 minutes after drug administration to 5 minutes before auditory test ]
    measure of time in minutes between the administration of the drug and the obtaining of a correct sedation (4, 5 or 6 of the score of Ramsey).

  3. time of vigilance recovery [ Time Frame: from 5 minutes after auditory test to 5 minutes after the patient wake up (Aldrete score equal to 9) ]
    measure the time between the end of the examination, (defined by the end of the recording and the disconnection of the electrodes) and the recovery of the vigilance of the child , evaluated by the Aldrete score . A score of 9 or more determines a correct recovery of alertness and the possibility of returning home. The child will be reevaluated every 10 minutes until this score is reached.



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Ages Eligible for Study:   1 Year to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Child aged 1 to 15 years old
  • American Society Anesthesiologists (ASA) scale patient 1 or 2
  • 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

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 cerebral vascular accident
  • Moyamoya disease
  • General anesthesia planned for another procedure

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 ClinicalTrials.gov identifier (NCT number): NCT03530371


Contacts
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Contact: Ana GIORDANO, MD +33(0)492030392 ext 1785 giordano.a@pediatrie-chulenval-nice.fr
Contact: Dominique DONZEAU, PhD +33(0)492034560 donzeau.d@chu-nice.fr

Locations
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France
Hôpitaux pédiatriques de Nice CHU-Lenval Recruiting
Nice, France, 06200
Contact: Ana GIORDANO, MD    +33(0)492030392 ext 1785    giordano.a@pediatrie-chulenval-nice.fr   
Sponsors and Collaborators
Fondation Lenval
Investigators
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Principal Investigator: Ana GIORDANO, MD Hôpitaux Pédiatriques de Nice CHU-LENVAL
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Responsible Party: Fondation Lenval
ClinicalTrials.gov Identifier: NCT03530371    
Other Study ID Numbers: 17-HPNCL-02
First Posted: May 21, 2018    Key Record Dates
Last Update Posted: July 28, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action