Determining the Pharmacogenetic Basis of Non-responsiveness to the Sedative Effects of Dexmedetomidine in Children

NCT04471402 | Unknown FDA Drug

• 1 other identifier: Precedex PG study
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Intranasal Dexmedetomidine is one of the sedative drugs of choice commonly used as an anxiolytic premedication for children for diagnostic or therapeutic procedures. However, some children do not achieve the level of sedation expected with the usual dose after an expected timeframe, leading to distress and costly time wasted. In this study, we would try to identify a genetic basis to non-responders of Dexmedetomidine by comparing a chosen gene panel of 250 relevant genes between responders and non-responders to a standardized 3mcg/kg intranasal Dexmedetomidine.

Conditions

Pharmacogenetic Study; Procedural Anxiety; Dexmedetomidine

Keywords

Procedural anxiety in children; Pharmacogenetic study; Dexmedetomidine; Sedation

Outcome Measures

Primary Outcomes (1)

• Sedative response to intranasal Precedex

  Sedation response is recorded every 5 minutes after administration of Precedex until a satisfactory sedation level is reached. A satisfactory sedation level is defined as a UMSS of 3-4 (University of Michigan Sedation Scale) and allowing transfer to bed without waking up. Subjects are categorized into 'fast responder', 'normal responder', 'slow responder' and 'definite non-responder' based on the time required to achieve satisfactory level of sedation

  Every 5 minutes till 30 minutes from administration of intranasal Precedex

Secondary Outcomes (7)

• Onset time of sedation

  45 minutes from administration of intranasal Precedex

• Incidence of bradycardia

  2 hour from administration of intranasal Precedex or until administration of other sedative or anaesthetic drugs, whichever is shorter

• Incidence of hypotension

  2 hours from administration of intranasal Precedex, or until administration of other sedative or anaesthetic drugs, whichever is shorter

• Incidence of hypertension

  2 hours from administration of intranasal Precedex, or until administration of other sedative or anaesthetic drugs, whichever is shorter

• Incidence of hypoxia

  2 hours from administration of intranasal Precedex, or until administration of other sedative or anaesthetic drugs, whichever is shorter

Study Arms (1)

All subjects recruited

All subjects recruited will be given 3mcg/kg intranasal Precedex through an atomiser, divided equally between two nostrils. They will be observed and sedation score will be recorded every 5 minutes according to the University of Michigan Sedation Scale (UMSS). Pulse oximetry and Blood pressure cuff will be applied whenever they accept these monitoring. A buccal swab sample will be taken from all children and the identified genes will be analysed and compared between the different responders (fast, normal, slow or non-responders).

Drug: Precedex

Interventions

Precedex DRUG

Intranasal Precedex 3mcg/kg

Also known as: Dexmedetomidine

All subjects recruited

Eligibility Criteria

• Age: 6 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children who require intranasal Precedex at 3 mcg/kg as an anxiolytic premedication for radiological or pre-anaesthesia sedation in Hong Kong Children's Hospital

You may qualify if:

• Children who would receive 3mcg/kg intranasal Precedex as a first line sedative agent for radiological procedures or for pre-anaesthesia sedation
• Written informed consent from parent or legal guardian

You may not qualify if:

• Known allergy or hypersensitivity to Precedex
• Pre-existing developmental delay
• Neurological impairment
• Autism
• Fever (temperature \>/= 38.5c)
• Major organ dysfunction
• Cardiac arrhythmia
• Cardiac failure
• Subjects who would require a dose exceeding 100mcg if 3mcg/kg dose is achieved
• Subjects who have failed intranasal administration of Dexmedetomidine

Sponsors & Collaborators

• Hong Kong Children's Hospital: lead

Study Sites (1)

Hong Kong Children's Hospital

Hong Kong, Hong Kong

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Buccal swab samples are taken from subjects for DNA analysis

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Vivian MY Yuen, M.D.

  Hong Kong Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vivian MY Yuen, M.D.

CONTACT

+852 57413131; yuenmyv@ha.org.hk

Jacqueline CK Tse, MBBS

CONTACT

+852 57413200; tck030@ha.org.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: July 15, 2020
• Study Start: July 20, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 16, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)