Emergence Deliruim; Cerebral PalsyPhase 4NCT02244515
Consequence of Dexmedetomidine on Emergence Deliruim After Sevoflurane Anesthesia in Children With Cerebral Palsy
A Phase 4 study testing dexmedetomidine in people with Emergence Deliruim; Cerebral Palsy, run by Jin Ni.
Trial summary
The purpose of this study is to determine whether dexmedetomidine is effective in the treatment of emergence deliruim after sevoflurane anesthesia in children with cerebral palsy. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Emergence Deliruim; Cerebral Palsy
- What is being tested?
- dexmedetomidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Sep 2014
- 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Non-quadriplegic (mono-,di-, hemiplegic) children with CP that are scheduled for elective Achilles-tendon lengthening procedure Guangzhou Women and Children's Medical Center, Guangzhou, China, with American Society of Anesthesiologists (ASA) physical status I or II.
Who cannot join
- Participants that displayed symptoms of sinus bradycardia and atrio-ventricular block, non-communicative severe developmental delay, seizure disorders, and treatment with seizure medications
About this study
The purpose of this study is to determine whether dexmedetomidine is effective in the treatment of emergence deliruim after sevoflurane anesthesia in children with cerebral palsy.
- Conditions
- Emergence Deliruim; Cerebral Palsy
- Being tested
- dexmedetomidine
- Keywords
- children
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidineDrug
dexmedetomidine 0.5μg•kg-1 diluted in 10 ml NaCI 0.9%
| Study group | Role | What they receive |
|---|---|---|
| Group C | Placebo comparator | Five minutes prior to the commencement of the surgical procedure, Group D participants were administered 10 ml NaCI 0.9%. |
| Group D | Experimental | Five minutes prior to the commencement of the surgical procedure, Group D participants were administered dexmedetomidine 0.5μg•kg-1 diluted in 10 ml NaCI 0.9% Receives: Drug: dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
pediatric anesthesia emergence delirium (PAED) scale
Measured: during stay in postanesthesia care unit
Heart rate
Measured: during surgical procedures
systolic blood pressure
Measured: during surgical procedures
diastolic blood pressure
Measured: during surgical procedures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study startJun 2014
- Primary completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergence Deliruim; Cerebral PalsyStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jin Ni
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jin Ni, Guangzhou Women and Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02244515
- Sponsor's protocol ID
- ED cerebral palsy
- Status last verified
- Sep 2014
- First submitted
- 17 Sep 2014
- Last updated
- 19 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consequence of Dexmedetomidine on Emergence Deliruim After Sevoflurane Anesthesia in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT02244515
- Acronym / sponsor ID
- ED cerebral palsy
- Conditions
- Emergence Deliruim; Cerebral Palsy
- Keywords
- children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Jin NiUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Sep 2014 (actual)
- First posted
- 19 Sep 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.
The purpose of this study is to determine whether dexmedetomidine is effective in the treatment of emergence deliruim after sevoflurane anesthesia in children with cerebral palsy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group C | Placebo comparator | –Five minutes prior to the commencement of the surgical procedure, Group D participants were administered 10 ml NaCI 0.9%. |
| Group D | Experimental | Drug: dexmedetomidineFive minutes prior to the commencement of the surgical procedure, Group D participants were administered dexmedetomidine 0.5μg•kg-1 diluted in 10 ml NaCI 0.9% |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Non-quadriplegic (mono-,di-, hemiplegic) children with CP that are scheduled for elective Achilles-tendon lengthening procedure Guangzhou Women and Children's Medical Center, Guangzhou, China, with American Society of Anesthesiologists (ASA) physical status I or II.
Key exclusion criteria (1 listed)
- Participants that displayed symptoms of sinus bradycardia and atrio-ventricular block, non-communicative severe developmental delay, seizure disorders, and treatment with seizure medications
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 |
|---|---|---|
| dexmedetomidinedexmedetomidine 0.5μg•kg-1 diluted in 10 ml NaCI 0.9% | Drug | Group D |
Primary outcome
pediatric anesthesia emergence delirium (PAED) scale
Time frame: during stay in postanesthesia care unit
Heart rate
Time frame: during surgical procedures
systolic blood pressure
Time frame: during surgical procedures
diastolic blood pressure
Time frame: during surgical procedures
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2014.
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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dexmedetomidine in people with Emergence Deliruim; Cerebral Palsy, run by Jin Ni.
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: status not confirmed, as of the sponsor's last update on 19 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
pediatric anesthesia emergence delirium (PAED) scale (time frame: during stay in postanesthesia care unit). The study lists 4 primary outcomes in all. 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 19 Sep 2014.