Patient Between 1-8 Years Old Undergoing Elective Surgery at Queen Mary HospitalPhase 3NCT01065701
Comparison of Two Doses of Intranasal Dexmedetomidine as Premedication in Children
A Phase 3 study testing Dexmedetomidine in people with Patient Between 1-8 Years Old Undergoing Elective Surgery at Queen Mary Hospital, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Intranasal dexmedetomidine has shown to be an effective sedative when used prior to anaesthetic induction as premedication. 1mcg/kg intranasal dexmedetomidine was used in previous study and it produced satisfactory sedation in more than 50% of the children at the time of anaesthetic induction with no adverse effect. Read more about this study
- Who is it for?
- Ages 1 year to 8 years
- Conditions the study is for
- Patient Between 1-8 Years Old Undergoing Elective Surgery at Queen Mary Hospital
- What is being tested?
- Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteHong Kong
- Study dates
- Jul 2009to Aug 2010
- Phase
- Phase 3
- 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 1 year to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 1-12 years old
- American Society of Anesthesiologists (ASA) 1-2
- Elective surgery
- Children with autism or pervasive personality disorder
Who cannot join
- American Society of Anaesthesiologists (ASA) 3-5
- Allergy or hypersensitive reaction to dexmedetomidine
- Known cardiac arrhythmia or congenital heart disease
- Mentally disabled
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Doses of Intranasal Dexmedetomidine as Premedication in Children - a Double-blinded Randomized Controlled Trial
Intranasal dexmedetomidine has shown to be an effective sedative when used prior to anaesthetic induction as premedication. 1mcg/kg intranasal dexmedetomidine was used in previous study and it produced satisfactory sedation in more than 50% of the children at the time of anaesthetic induction with no adverse effect. In this study we aim to compare 1mcg/kg with 2mcg/kg intranasal dexmedetomidine in children. We expect more children would attain satisfactory sedation prior to anaesthetic induction when higher dose is used.
- Being tested
- Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Intranasal dexmedetomidine is given as premedication prior to induction of anesthesia
| Study group | Role | What they receive |
|---|---|---|
| 1mcg/kg | Active comparator | 1mcg/kg intranasal dexmedetomidine administered 45 minutes befoe anesthesia induction Receives: Drug: Dexmedetomidine |
| 2mcg/kg | Active comparator | 2mcg/kg intranasal dexmedetomidine given 45 minutes prior to anesthetic induction Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of children attained satisfactory sedation
Measured: one hour
Secondary outcomes (1)
time to onset of sedation
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2010 (estimated)
- Study startJul 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient Between 1-8 Years Old Undergoing Elective Surgery at Queen Mary HospitalStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YUEN, Vivian Man-ying, The University of Hong Kong
- Investigators
- Vivian M Yuen, MBBS, Principal investigator, Associate Consultant, Queen Mary Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01065701
- Sponsor's protocol ID
- InDex3
- Status last verified
- Oct 2017
- First submitted
- 7 Feb 2010
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Doses of Intranasal Dexmedetomidine as Premedication in Children - a Double-blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01065701
- Acronym / sponsor ID
- InDex3
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 9 Feb 2010 (estimated)
- 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 has shown to be an effective sedative when used prior to anaesthetic induction as premedication. 1mcg/kg intranasal dexmedetomidine was used in previous study and it produced satisfactory sedation in more than 50% of the children at the time of anaesthetic induction with no adverse effect. In this study we aim to compare 1mcg/kg with 2mcg/kg intranasal dexmedetomidine in children. We expect more children would attain satisfactory sedation prior to anaesthetic induction when higher dose is used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1mcg/kg | Active comparator | Drug: Dexmedetomidine1mcg/kg intranasal dexmedetomidine administered 45 minutes befoe anesthesia induction |
| 2mcg/kg | Active comparator | Drug: Dexmedetomidine2mcg/kg intranasal dexmedetomidine given 45 minutes prior to anesthetic induction |
Who may qualify
- Ages
- 1 year to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age 1-12 years old
- American Society of Anesthesiologists (ASA) 1-2
- Elective surgery
- Children with autism or pervasive personality disorder
Key exclusion criteria (4 listed)
- American Society of Anaesthesiologists (ASA) 3-5
- Allergy or hypersensitive reaction to dexmedetomidine
- Known cardiac arrhythmia or congenital heart disease
- Mentally disabled
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 |
|---|---|---|
| DexmedetomidineIntranasal dexmedetomidine is given as premedication prior to induction of anesthesia | Drug | 1mcg/kg, 2mcg/kg |
Primary outcome
proportion of children attained satisfactory sedation
Time frame: one hour
1 secondary outcome
time to onset of sedation
Time frame: one hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
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 M Yuen, MBBS principal investigator
Associate Consultant, Queen Mary Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexmedetomidine in people with Patient Between 1-8 Years Old Undergoing Elective Surgery at Queen Mary Hospital, run by The University of Hong Kong 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 26 Oct 2017. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of children attained satisfactory sedation (time frame: one hour). 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 26 Oct 2017.