AgedPhase 4NCT02253199
The Effect of Age on the Median Effective Dose (ED50) of Intranasal Dexmedetomidine for Rescue Sedation Following Failed Sedation With Oral Chloral Hydrate During Magnetic Resonance Imaging
A Phase 4 study testing intranasal dexmedetomidine in people with Aged and Drug, run by Guangzhou Women and Children's Medical Center at 1 site in China.
Trial summary
Increasing evidences suggest that dexmedetomidine Pharmacokinetic are different in children. We performed a up-down sequential allocation study to determine the ED50 for rescue sedation following sedation failures in children and to investigate age-related differences in the rescue sedation with dexmedetomidine. Read more about this study
- Who is it for?
- Ages 1 month to 36 months
- Conditions the study is for
- Aged, Drug, Dose-Response Relationship
- What is being tested?
- intranasal dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Oct 2014to Mar 2016
- Phase
- Phase 4
- 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 month to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 150 children of ASA physical status I or II, aged between 1 and 36 months, failed chloral hydrate sedation during MRI scanning,
Who cannot join
- known allergy or hypersensitive reaction to drugs of this study, Weight greater than 20 kg or less than 4.5 kg, organ dysfunction, pneumonia, acute upper respiratory airway inflammation, preterm, cardiac arrhythmia and congenital heart disease.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anesthesiology of Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, 510000
About this study
Increasing evidences suggest that dexmedetomidine Pharmacokinetic are different in children. We performed a up-down sequential allocation study to determine the ED50 for rescue sedation following sedation failures in children and to investigate age-related differences in the rescue sedation with dexmedetomidine.
Read the detailed description
About 150 children who were not adequately sedated ( no evidence of adequate sedation within 30 min after administration of Initial dose of chloral hydrate) were stratified into four age groups as follows: 1-6 month, 7 -12 month, 13 -24 month, and 25-36 month. The intranasal dexmedetomidine dose was determined by the success or failure of rescue sedation achieved by the previous patients, according to Dixon's up-down sequential allocation method. Successful sedation was defined as a MOAA/S(modified Observer Assessment of Alertness and Sedation) of between 0 and 3. The EC50 were estimated from the up-and-down sequences using the method of Dixon and Massey and logistic regression. Patients' sedation status, sedation induction time, time to Wake up, blood pressure, heart rate, and oxygen saturation were recorded.
- Conditions
- Aged, Drug, Dose-Response Relationship
- Being tested
- intranasal dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intranasal dexmedetomidineDrug
Children who were not adequately sedated ( no evidence of adequate sedation within 30 min after administration of Initial dose of chloral hydrate) received a bolus of intranasal dexmedetomidine which adjusted by the "Dixon up-and-down method for rescue sedation.
The first child received 0.8mcg/Kg of intranasal dexmedetomidine dose (100mcg/ml), and the dose interval was set at 0.1mcg/Kg.
| Study group | Role | What they receive |
|---|---|---|
| 1-6 months (Group 1) | Active comparator | Subjects stratified into four groups according to age: 1-6 months (Group 1), 7-12 months (Group 2),13-24 months (Group 3), 26-36 months (Group 4). Receives: Drug: intranasal dexmedetomidine |
| 7-12 months (Group 2) | Active comparator | Subjects stratified into four groups according to age: 1-6 months (Group 1), 7-12 months (Group 2),13-24 months (Group 3), 26-36 months (Group 4). Receives: Drug: intranasal dexmedetomidine |
| 13-24 months (Group 3) | Active comparator | Subjects stratified into four groups according to age: 1-6 months (Group 1), 7-12 months (Group 2),13-24 months (Group 3), 26-36 months (Group 4). Receives: Drug: intranasal dexmedetomidine |
| 25-36 months (Group 4) | Active comparator | Subjects stratified into four groups according to age: 1-6 months (Group 1), 7-12 months (Group 2),13-24 months (Group 3), 26-36 months (Group 4). Receives: Drug: intranasal dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The median effect dose of intranasal dexmedetomidine
Sedation status was evaluated by a attending anesthesiologists every 5-10 min with a 6-point sedation scale, which was modified from the Modified Observer Assessment of Alertness and Sedation Scale (MOAA/S).successful sedation was defined as an MOAA/S of between 0 and 3
Measured: up to 1 hours after MRI scaning
Secondary outcomes (2)
sedation induction time
Successful sedation was defined as an MOAA/S of between 0 and 3, and sedation induction time was defined as the time from rescue drug administration to the onset of satisfactory sedation
0 Does not respond to a noxious stimulus
- Does not respond to mild prodding or shaking
- Responds only after mild prodding or shaking
- Responds only after name is called loudly orrepeatedly
- Lethargic response to name spoken in normal tone
- Appears asleep, but responds readily to namespoken in normal tone
- Appears alert and awake, responds readily to namespoken in normal tone
Measured: up to 30 min after rescue drug administration
Wake -up time
Children were classified as awake if the MOAA/S was between 4 and 6. Wake -up time was defined as the time from successful sedation until the time that the child awoke
Measured: up to 4 hours after rescue drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionFeb 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgedStudies 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
- Interventional
- Phase
- Phase 4
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Women and Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenhua Zhang, Guangzhou Women and Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02253199
- Sponsor's protocol ID
- WZhang-02
- Status last verified
- Mar 2016
- First submitted
- 29 Sep 2014
- Last updated
- 29 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhang W, Fan Y, Zhao T, Chen J, Zhang G, Song X. Median Effective Dose of Intranasal Dexmedetomidine for Rescue Sedation in Pediatric Patients Undergoing Magnetic Resonance Imaging. Anesthesiology. 2016 Dec;125(6):1130-1135. doi: 10.1097/ALN.0000000000001353.
PubMed 27627818
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Age on the Median Effective Dose (ED50) of Intranasal Dexmedetomidine for Rescue Sedation Following Failed Sedation With Oral Chloral Hydrate During Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT02253199
- Acronym / sponsor ID
- WZhang-02
- Conditions
- Aged, Drug, Dose-Response Relationship
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Guangzhou Women and Children's Medical CenterUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 1 Oct 2014 (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.
Increasing evidences suggest that dexmedetomidine Pharmacokinetic are different in children. We performed a up-down sequential allocation study to determine the ED50 for rescue sedation following sedation failures in children and to investigate age-related differences in the rescue sedation with dexmedetomidine.
Detailed description
About 150 children who were not adequately sedated ( no evidence of adequate sedation within 30 min after administration of Initial dose of chloral hydrate) were stratified into four age groups as follows: 1-6 month, 7 -12 month, 13 -24 month, and 25-36 month. The intranasal dexmedetomidine dose was determined by the success or failure of rescue sedation achieved by the previous patients, according to Dixon's up-down sequential allocation method. Successful sedation was defined as a MOAA/S(modified Observer Assessment of Alertness and Sedation) of between 0 and 3. The EC50 were estimated from the up-and-down sequences using the method of Dixon and Massey and logistic regression. Patients' sedation status, sedation induction time, time to Wake up, blood pressure, heart rate, and oxygen saturation were recorded.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1-6 months (Group 1) | Active comparator | Drug: intranasal dexmedetomidineSubjects stratified into four groups according to age: 1-6 months (Group 1), 7-12 months (Group 2),13-24 months (Group 3), 26-36 months (Group 4). |
| 7-12 months (Group 2) | Active comparator | Drug: intranasal dexmedetomidineSubjects stratified into four groups according to age: 1-6 months (Group 1), 7-12 months (Group 2),13-24 months (Group 3), 26-36 months (Group 4). |
| 13-24 months (Group 3) | Active comparator | Drug: intranasal dexmedetomidineSubjects stratified into four groups according to age: 1-6 months (Group 1), 7-12 months (Group 2),13-24 months (Group 3), 26-36 months (Group 4). |
| 25-36 months (Group 4) | Active comparator | Drug: intranasal dexmedetomidineSubjects stratified into four groups according to age: 1-6 months (Group 1), 7-12 months (Group 2),13-24 months (Group 3), 26-36 months (Group 4). |
Who may qualify
- Ages
- 1 month to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 150 children of ASA physical status I or II, aged between 1 and 36 months, failed chloral hydrate sedation during MRI scanning,
Key exclusion criteria (1 listed)
- known allergy or hypersensitive reaction to drugs of this study, Weight greater than 20 kg or less than 4.5 kg, organ dysfunction, pneumonia, acute upper respiratory airway inflammation, preterm, cardiac arrhythmia and congenital heart disease.
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 |
|---|---|---|
| intranasal dexmedetomidineChildren who were not adequately sedated ( no evidence of adequate sedation within 30 min after administration of Initial dose of chloral hydrate) received a bolus of intranasal dexmedetomidine which adjusted by the "Dixon up-and-down method for rescue sedation. The first child received 0.8mcg/Kg of intranasal dexmedetomidine dose (100mcg/ml), and the dose interval was set at 0.1mcg/Kg. | Drug | 1-6 months (Group 1), 13-24 months (Group 3), 25-36 months (Group 4), 7-12 months (Group 2) |
Primary outcome
The median effect dose of intranasal dexmedetomidine
Time frame: up to 1 hours after MRI scaning
Sedation status was evaluated by a attending anesthesiologists every 5-10 min with a 6-point sedation scale, which was modified from the Modified Observer Assessment of Alertness and Sedation Scale (MOAA/S).successful sedation was defined as an MOAA/S of between 0 and 3
2 secondary outcomes
sedation induction time
Time frame: up to 30 min after rescue drug administration
Wake -up time
Time frame: up to 4 hours after rescue drug administration
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 29 Mar 2016.
- Derived from this study: PubMed 27627818Zhang W, Fan Y, Zhao T, Chen J, Zhang G, Song X. Median Effective Dose of Intranasal Dexmedetomidine for Rescue Sedation in Pediatric Patients Undergoing Magnetic Resonance Imaging. Anesthesiology. 2016 Dec;125(6):1130-1135. doi: 10.1097/ALN.0000000000001353.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing intranasal dexmedetomidine in people with Aged and Drug, run by Guangzhou Women and Children's Medical Center at 1 site in China.
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 1 inclusion and 1 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 29 Mar 2016. 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 China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The median effect dose of intranasal dexmedetomidine (time frame: up to 1 hours after MRI scaning). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02253199, which also lists 1 linked publication.
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 29 Mar 2016.