The Efficacy and Safety of Intranasal DexmedetomidinePhase 4NCT02222636
The Clinical Research of Intranasal Dexmedetomidine Used in Plastic Surgery of Children
A Phase 4 study testing Normal saline,1 milliliter, Dexmedetomidine 1 μg.kg-1,1 milliliter and Dexmedetomidine 2μg.kg-1,1 milliliter in people with The Efficacy and Safety of Intranasal Dexmedetomidine, run by Xijing Hospital.
Trial summary
The purpose of this study is to explore the optimal protocol for dexmedetomidine used in children during perioperative period. Read more about this study
- Who is it for?
- Ages 6 months to 7 years
- Conditions the study is for
- The Efficacy and Safety of Intranasal Dexmedetomidine
- What is being tested?
- Normal saline,1 milliliter, Dexmedetomidine 1 μg.kg-1,1 milliliter and Dexmedetomidine 2μg.kg-1,1 milliliter
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Dec 2015
- 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 6 months to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Written informed consent.
- Elective cleft lip and cleft palate repair surgery
- American Society of Anesthesiologists class I
- Aged between 6 months and 7 years old
Who cannot join
- Suspected or confirmed difficult airway
- History of upper respiratory tract infection with 1 month
- Combined with congenital heart disease
- Allergic to investigational products or with other contraindication
- Growth retardation or dysgnosia
- Central nervous system disease
- Serious infection
- Serious heart,brain,liver,kidney, pulmonary, and endocrine disease
About this study
Official title: The Clinical Research of Intranasal Dexmedetomidine Used in Plastic Surgery of Children : A Single Center ,Randomized ,Double-blinded, Controlled Study.
The purpose of this study is to explore the optimal protocol for dexmedetomidine used in children during perioperative period.
- Being tested
- Normal saline,1 milliliter, Dexmedetomidine 1 μg.kg-1,1 milliliter, Dexmedetomidine 2μg.kg-1,1 milliliter, Anesthesia induction, 8% sevoflurane, Anesthesia maintenance, 2%~3% sevoflurane,fentanyl
- Keywords
- The efficacy and safety of intranasal dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal saline,1 milliliterDrug
Normal saline,1 milliliter, 20 minutes before anaesthetic induction
Dexmedetomidine 1 μg.kg-1,1 milliliterDrug
Dexmedetomidine 1 μg.kg-1,1 milliliter,20 minutes before anesthesia induction
Dexmedetomidine 2μg.kg-1,1 milliliterDrug
Dexmedetomidine 2μg.kg-1,1 milliliter,20 minutes before anesthesia induction
Anesthesia induction, 8% sevofluraneDrug
Inhalation induction with 8% sevoflurane
Anesthesia maintenance, 2%~3% sevoflurane,fentanylDrug
2%~3% sevoflurane,inhalation. fentanyl,2μg.kg-1.min-1,intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Group 1,Normal saline,1 milliliter | Placebo comparator | Patients will be assigned to receive intranasal normal saline 1 milliliter Receives: Drug: Normal saline,1 milliliter; Drug: Anesthesia induction, 8% sevoflurane; Drug: Anesthesia maintenance, 2%~3% sevoflurane,fentanyl |
| Group 2,dexmedetomidine 1μg.kg-1,1 milliliter | Experimental | Patients will be assigned to receive intranasal dexmedetomidine( 1μg.kg-1) 1 milliliter Receives: Drug: Dexmedetomidine 1 μg.kg-1,1 milliliter; Drug: Anesthesia induction, 8% sevoflurane; Drug: Anesthesia maintenance, 2%~3% sevoflurane,fentanyl |
| Group 3,dexmedetomidine 2μg.kg-1,1 milliliter | Experimental | Patients will be assigned to receive intranasal dexmedetomidine( 2μg.kg-1 )1 milliliter Receives: Drug: Dexmedetomidine 2μg.kg-1,1 milliliter; Drug: Anesthesia induction, 8% sevoflurane; Drug: Anesthesia maintenance, 2%~3% sevoflurane,fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sedation-Agitation Scale
Measured: The moment of entering operating room,20 minutes before anesthesia induction,10 minutes before anesthesia inducion,the moment of anesthesia induction
The pediatric anesthesia emergence delirium scale
Measured: The moment of entering operating room,and from discontinuation of inhalational anesthetics to the moment of patient's consciousness recovery,an expected average of 1 hour
Anesthesia induction time
Measured: From beginning of inhalating anesthetics to the moment of intubation
Anesthesia maintenance time
Measured: From the moment of intubation to the discontinuation of inhalational anesthestics
Recovery time
Measured: From discontinuation of inhalational anesthestics to the moment of patient's consciousness recovery, an expected average of 1 hour
Change from baseline in blood pressure during anesthesia
Measured: The moment of entering operating room,20 minutes before anesthesia induction,10 minutes before anesthesia inducion,the moment of anesthesia induction
Change from baseline in heart rate during anesthesia
Measured: The moment of entering operating room,20 minutes before anesthesia induction,10 minutes before anesthesia inducion,the moment of anesthesia induction
Change from baseline in respiratory rate during anesthesia
Measured: The moment of entering operating room,20 minutes before anesthesia induction,10 minutes before anesthesia inducion,the moment of anesthesia induction
Secondary outcomes (1)
The alveolar concentration of inhalational anesthetics
Measured: the moment of anesthesia induction,the moment of intubation,before cutting skin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionAug 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Efficacy and Safety of Intranasal DexmedetomidineStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, wangqiang, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02222636
- Sponsor's protocol ID
- Sedation wei
- Status last verified
- Aug 2014
- First submitted
- 14 Aug 2014
- Last updated
- 21 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Research of Intranasal Dexmedetomidine Used in Plastic Surgery of Children : A Single Center ,Randomized ,Double-blinded, Controlled Study.
- ClinicalTrials.gov ID
- NCT02222636
- Acronym / sponsor ID
- Sedation wei
- Keywords
- The efficacy and safety of intranasal dexmedetomidine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 21 Aug 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 explore the optimal protocol for dexmedetomidine used in children during perioperative period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1,Normal saline,1 milliliter | Placebo comparator | Drug: Normal saline,1 milliliter, Drug: Anesthesia induction, 8% sevoflurane, Drug: Anesthesia maintenance, 2%~3% sevoflurane,fentanylPatients will be assigned to receive intranasal normal saline 1 milliliter |
| Group 2,dexmedetomidine 1μg.kg-1,1 milliliter | Experimental | Drug: Dexmedetomidine 1 μg.kg-1,1 milliliter, Drug: Anesthesia induction, 8% sevoflurane, Drug: Anesthesia maintenance, 2%~3% sevoflurane,fentanylPatients will be assigned to receive intranasal dexmedetomidine( 1μg.kg-1) 1 milliliter |
| Group 3,dexmedetomidine 2μg.kg-1,1 milliliter | Experimental | Drug: Dexmedetomidine 2μg.kg-1,1 milliliter, Drug: Anesthesia induction, 8% sevoflurane, Drug: Anesthesia maintenance, 2%~3% sevoflurane,fentanylPatients will be assigned to receive intranasal dexmedetomidine( 2μg.kg-1 )1 milliliter |
Who may qualify
- Ages
- 6 months to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Written informed consent.
- Elective cleft lip and cleft palate repair surgery
- American Society of Anesthesiologists class I
- Aged between 6 months and 7 years old
Key exclusion criteria (8 listed)
- Suspected or confirmed difficult airway
- History of upper respiratory tract infection with 1 month
- Combined with congenital heart disease
- Allergic to investigational products or with other contraindication
- Growth retardation or dysgnosia
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 |
|---|---|---|
| Normal saline,1 milliliterNormal saline,1 milliliter, 20 minutes before anaesthetic induction | Drug | Group 1,Normal saline,1 milliliter |
| Dexmedetomidine 1 μg.kg-1,1 milliliterDexmedetomidine 1 μg.kg-1,1 milliliter,20 minutes before anesthesia induction | Drug | Group 2,dexmedetomidine 1μg.kg-1,1 milliliter |
| Dexmedetomidine 2μg.kg-1,1 milliliterDexmedetomidine 2μg.kg-1,1 milliliter,20 minutes before anesthesia induction | Drug | Group 3,dexmedetomidine 2μg.kg-1,1 milliliter |
| Anesthesia induction, 8% sevofluraneInhalation induction with 8% sevoflurane | Drug | Group 1,Normal saline,1 milliliter, Group 2,dexmedetomidine 1μg.kg-1,1 milliliter, Group 3,dexmedetomidine 2μg.kg-1,1 milliliter |
| Anesthesia maintenance, 2%~3% sevoflurane,fentanyl2%~3% sevoflurane,inhalation. fentanyl,2μg.kg-1.min-1,intravenous infusion | Drug | Group 1,Normal saline,1 milliliter, Group 2,dexmedetomidine 1μg.kg-1,1 milliliter, Group 3,dexmedetomidine 2μg.kg-1,1 milliliter |
Primary outcome
Sedation-Agitation Scale
Time frame: The moment of entering operating room,20 minutes before anesthesia induction,10 minutes before anesthesia inducion,the moment of anesthesia induction
The pediatric anesthesia emergence delirium scale
Time frame: The moment of entering operating room,and from discontinuation of inhalational anesthetics to the moment of patient's consciousness recovery,an expected average of 1 hour
Anesthesia induction time
Time frame: From beginning of inhalating anesthetics to the moment of intubation
Anesthesia maintenance time
Time frame: From the moment of intubation to the discontinuation of inhalational anesthestics
Recovery time
Time frame: From discontinuation of inhalational anesthestics to the moment of patient's consciousness recovery, an expected average of 1 hour
Change from baseline in blood pressure during anesthesia
Time frame: The moment of entering operating room,20 minutes before anesthesia induction,10 minutes before anesthesia inducion,the moment of anesthesia induction
Change from baseline in heart rate during anesthesia
Time frame: The moment of entering operating room,20 minutes before anesthesia induction,10 minutes before anesthesia inducion,the moment of anesthesia induction
Change from baseline in respiratory rate during anesthesia
Time frame: The moment of entering operating room,20 minutes before anesthesia induction,10 minutes before anesthesia inducion,the moment of anesthesia induction
1 secondary outcome
The alveolar concentration of inhalational anesthetics
Time frame: the moment of anesthesia induction,the moment of intubation,before cutting skin
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2014.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Normal saline,1 milliliter, Dexmedetomidine 1 μg.kg-1,1 milliliter and Dexmedetomidine 2μg.kg-1,1 milliliter in people with The Efficacy and Safety of Intranasal Dexmedetomidine, run by Xijing Hospital.
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 8 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 21 Aug 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?
Sedation-Agitation Scale (time frame: The moment of entering operating room,20 minutes before anesthesia induction,10 minutes before anesthesia inducion,the moment of anesthesia induction). The study lists 8 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 21 Aug 2014.