Pharmacogenetic StudyNCT04471402
Determining the Pharmacogenetic Basis of Non-responsiveness to the Sedative Effects of Dexmedetomidine in Children
An observational study of Pharmacogenetic Study and Procedural Anxiety, run by Hong Kong Children's Hospital at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 months to 12 years
- Conditions the study is for
- Pharmacogenetic Study, Procedural Anxiety, Dexmedetomidine
- What is being tested?
- Precedex
- How many people
- 100 participants
- Where
- 1 siteHong Kong
- Study dates
- 20 Jul 2020to 31 Dec 2022
- Phase
- Observational
- 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 6 months to 12 years
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- 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
Who cannot join
- Known allergy or hypersensitivity to Precedex
- Pre-existing developmental delay
- Neurological impairment
- Autism
- Fever (temperature >/= 38.5c)
- Major organ dysfunction
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Hong Kong Children's Hospital
Hong Kong
Vivian MY Yuen, M.D., +852 57413131, yuenmyv@ha.org.hk
Jacqueline CK Tse, MBBS, +852 57413200, tck030@ha.org.hk
About this study
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.
Read the detailed description
For most children, having to endure a diagnostic or therapeutic procedure in a hospital environment is a frightening and distressing experience, especially if it is accompanied by pain or discomfort. In an attempt to minimise the trauma and to maximise co-operation from the child, administration of a sedative is often requested by either the parent or the proceduralist. Some sedative agents may have the side effect reducing the child's efforts in breathing, causing inadequate oxygen to be delivered to and carbon dioxide removed from the body, a state that can be life threatening if left untreated. Other sedative agents may cause unpleasant sensations such as hallucinations or nausea while still others may have a paradoxical effect of exciting rather than sedating the child. Among the available agents that may be administered without the presence of an attendant anaesthesiologist, dexmedetomidine is an agent of choice with minimal incidence of the aforementioned effects. However, we have observed in a small proportion of children that dexmedetomidine does not see to be able to elicit a sedative response in the expected time and with the usual dose. It is possible that there is a genetic bas to this resistance and it would be of great use to be able to predict the non-responders ahead of time so an appropriate alternative may be selected without a trial and error approach.
In this project, children who would require Precedex as first-line sedation for radiological or pre-anaesthesia sedation are asked to participate by providing a buccal swab sample and have their genome (genetic makeup) characterised by target sequencing. They are standardized into receiving 3mcg/kg intranasal Precedex and are observed every 5 minutes afterwards for their level of sedation. They would be identified as 'fast responder', 'normal responder', 'slow responder' and 'definite non-responder'.
A gene panel of 250 relevant genes is chosen and compared between the different groups of responders and non-responders. We will then try to look for the differences between these groups and we will use this information to build a predictive model. This model will help to identify non-responders in the future and this would allow clinicians to prepare for an alternative approach to sedation. This would save time, distress to the child and parent and ultimately cost to the institution.
- Conditions
- Pharmacogenetic Study, Procedural Anxiety, Dexmedetomidine
- Being tested
- Precedex
- Keywords
- Procedural anxiety in children, Pharmacogenetic study, Dexmedetomidine, Sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrecedexDrug
Also called Dexmedetomidine
Intranasal Precedex 3mcg/kg
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Precedex |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Every 5 minutes till 30 minutes from administration of intranasal Precedex
Secondary outcomes (7)
Onset time of sedation
The actual time required to reach a satisfactory sedation level after administration of intranasal Precedex
Measured: 45 minutes from administration of intranasal Precedex
Incidence of bradycardia
Defined as more than 20% reduction in heart rate from baseline or from the lower limit of published normal values for age, whichever is lower
Measured: 2 hour from administration of intranasal Precedex or until administration of other sedative or anaesthetic drugs, whichever is shorter
Incidence of hypotension
Defined as a systolic blood pressure more than 20% lower than the published normal values for age
Measured: 2 hours from administration of intranasal Precedex, or until administration of other sedative or anaesthetic drugs, whichever is shorter
Incidence of hypertension
Defined as a systolic blood pressure more than 20% higher than the published normal values for age
Measured: 2 hours from administration of intranasal Precedex, or until administration of other sedative or anaesthetic drugs, whichever is shorter
Incidence of hypoxia
Defined as a SpO2 < or equal to 93% or more than 5% decrease from baseline
Measured: 2 hours from administration of intranasal Precedex, or until administration of other sedative or anaesthetic drugs, whichever is shorter
Wake up time
Time to reach UMSS of 1 or below after completion of procedure
Measured: 1 hour after completion of procedure
Length of procedure
Length of procedure is recorded
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start20 Jul 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacogenetic StudyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hong Kong Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vivian MY Yuen, M.D., Principal investigator, Hong Kong Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04471402
- Sponsor's protocol ID
- Precedex PG study
- Status last verified
- Aug 2021
- First submitted
- 8 Jul 2020
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Pharmacogenetic Basis of Non-responsiveness to the Sedative Effects of Dexmedetomidine in Children
- ClinicalTrials.gov ID
- NCT04471402
- Acronym / sponsor ID
- Precedex PG study
- Conditions
- Pharmacogenetic Study, Procedural Anxiety, Dexmedetomidine
- Keywords
- Procedural anxiety in children, Pharmacogenetic study, Dexmedetomidine, Sedation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hong Kong Children's HospitalUniversity, hospital or other
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 15 Jul 2020 (actual)
- 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.
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.
Detailed description
For most children, having to endure a diagnostic or therapeutic procedure in a hospital environment is a frightening and distressing experience, especially if it is accompanied by pain or discomfort. In an attempt to minimise the trauma and to maximise co-operation from the child, administration of a sedative is often requested by either the parent or the proceduralist. Some sedative agents may have the side effect reducing the child's efforts in breathing, causing inadequate oxygen to be delivered to and carbon dioxide removed from the body, a state that can be life threatening if left untreated. Other sedative agents may cause unpleasant sensations such as hallucinations or nausea while still others may have a paradoxical effect of exciting rather than sedating the child. Among the available agents that may be administered without the presence of an attendant anaesthesiologist, dexmedetomidine is an agent of choice with minimal incidence of the aforementioned effects. However, we have observed in a small proportion of children that dexmedetomidine does not see to be able to elicit a sedative response in the expected time and with the usual dose. It is possible that there is a genetic bas to this resistance and it would be of great use to be able to predict the non-responders ahead of time so an appropriate alternative may be selected without a trial and error approach.
In this project, children who would require Precedex as first-line sedation for radiological or pre-anaesthesia sedation are asked to participate by providing a buccal swab sample and have their genome (genetic makeup) characterised by target sequencing. They are standardized into receiving 3mcg/kg intranasal Precedex and are observed every 5 minutes afterwards for their level of sedation. They would be identified as 'fast responder', 'normal responder', 'slow responder' and 'definite non-responder'.
A gene panel of 250 relevant genes is chosen and compared between the different groups of responders and non-responders. We will then try to look for the differences between these groups and we will use this information to build a predictive model. This model will help to identify non-responders in the future and this would allow clinicians to prepare for an alternative approach to sedation. This would save time, distress to the child and parent and ultimately cost to the institution.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects recruited | – | Drug: PrecedexAll 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). |
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (10 listed)
- Known allergy or hypersensitivity to Precedex
- Pre-existing developmental delay
- Neurological impairment
- Autism
- Fever (temperature >/= 38.5c)
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 |
|---|---|---|
| PrecedexAlso: DexmedetomidineIntranasal Precedex 3mcg/kg | Drug | All subjects recruited |
Primary outcome
Sedative response to intranasal Precedex
Time frame: Every 5 minutes till 30 minutes from administration of 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
7 secondary outcomes
Onset time of sedation
Time frame: 45 minutes from administration of intranasal Precedex
Incidence of bradycardia
Time frame: 2 hour from administration of intranasal Precedex or until administration of other sedative or anaesthetic drugs, whichever is shorter
Incidence of hypotension
Time frame: 2 hours from administration of intranasal Precedex, or until administration of other sedative or anaesthetic drugs, whichever is shorter
Incidence of hypertension
Time frame: 2 hours from administration of intranasal Precedex, or until administration of other sedative or anaesthetic drugs, whichever is shorter
Incidence of hypoxia
Time frame: 2 hours from administration of intranasal Precedex, or until administration of other sedative or anaesthetic drugs, whichever is shorter
Wake up time
Time frame: 1 hour after completion of procedure
Length of procedure
Time frame: 3 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Vivian MY Yuen, M.D. principal investigator
Hong Kong Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pharmacogenetic Study and Procedural Anxiety, run by Hong Kong Children's Hospital at 1 site in Hong Kong.
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 2 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 16 Mar 2022. 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 Hong Kong. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vivian MY Yuen, M.D. (+852 57413131, yuenmyv@ha.org.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sedative response to intranasal Precedex (time frame: Every 5 minutes till 30 minutes from administration of intranasal Precedex). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Mar 2022.