Failed Conscious Sedation During ProcedurePhase 4NCT02296073
The Efficacy and the Safety of Dexmedetomidine Sedation on the Pediatric Intensive Unit(PICU) Patients.
A Phase 4 study testing Midazolam, Dexmedetomidine and Fentanyl in people with Failed Conscious Sedation During Procedure, run by Anhui Provincial Children's Hospital.
Trial summary
To observe the efficacy and safety of dexmedetomidine sedation on the patients admitted to the pediatric intensive care unit after surgery. Read more about this study
- Who is it for?
- Ages 1 month to 16 years
- Conditions the study is for
- Failed Conscious Sedation During Procedure
- What is being tested?
- Midazolam, Dexmedetomidine and Fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Dec 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 1 month to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- written informed consent；
- pediatric patients admitted to intensive care unit after general anesthesia;
- expected mechanical ventilation time >6 hours; （4）1 months to 16 years old; -
Who cannot join
- congenital heart disease, arrhythmias and heart failure;
- Alanine transaminase（ALT） and (or) Aspartate aminotransferase（AST） level is more than twice the upper limit of normal;
- Creatinine and (or) Blood urea nitrogen（BUN） is more than the upper limit of normal;
- central nervous system disease;
- spinal analgesia or muscle relaxants is used during PICU;
- the drug that affects the nerve conduction is used in one month;
- allergy to the test drug or having other contraindications;
- participated in other studies 30 days prior to admission of PICU; -
About this study
Official title: The Efficacy and the Safety of Dexmedetomidine Sedation on the PICU Patients-A Randomized, Controlled Study.
To observe the efficacy and safety of dexmedetomidine sedation on the patients admitted to the pediatric intensive care unit after surgery.
- Being tested
- Midazolam, Dexmedetomidine, Fentanyl, assessment
- Keywords
- Pediatric intensive care unit, Sedation, Dexmedetomidine, mechanical ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
Also called Liyuexi
midazolam 3～5μg/kg•min for maintenance of sedation.
DexmedetomidineDrug
Also called Yisi
Dexmedetomidine 0.5μg/kg intravenous bump for 15 min，then 0.2～1.4μg/(kg.h) for maintenance of sedation；
DexmedetomidineDrug
Also called Yisi
Dexmedetomidine 0.25μg/kg intravenous bump for 15 min，then 0.2～1.4μg/(kg.h) for maintenance of sedation；
DexmedetomidineDrug
Also called Yisi
Dexmedetomidine 0.2～1.4μg/(kg.h) for maintenance of sedation；
FentanylDrug
Also called Fentai
Fentanyl 0.5～4 μg/(kg.h) for maintenance of analgesia
assessmentOther
Ramsay score for sedation assessment, Facial expression, leg movement, activity, cry, and consolability score (FLACC) for analgesia assessment.
| Study group | Role | What they receive |
|---|---|---|
| Midazolam | Experimental | midazolam 3～5μg/kg•min for maintenance of sedation. Receives: Drug: Midazolam; Drug: Fentanyl; Other: assessment |
| Dexmedetomidine1 | Experimental | Dexmedetomidine 0.5μg/kg intravenous bump for 15 min，then 0.2～1.4μg/(kg.h) for maintenance of sedation； Receives: Drug: Dexmedetomidine; Drug: Fentanyl; Other: assessment |
| Dexmedetomidine2 | Experimental | Dexmedetomidine 0.25μg/kg intravenous bump for 15 min，then 0.2～1.4μg/(kg.h) for maintenance of sedation； Receives: Drug: Dexmedetomidine; Drug: Fentanyl; Other: assessment |
| Dexmedetomiding3 | Experimental | Dexmedetomidine 0.2～1.4μg/(kg.h) for maintenance of sedation； Receives: Drug: Dexmedetomidine; Drug: Fentanyl; Other: assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of time at target sedation score
assess the sedation level every 2 min using Ramsay score
Measured: up to 24 hours
the number of patients requiring the sedation remedy
the number of patients requiring the sedation remedy during the mechanical ventilation
Measured: up to 24 hours
the dosage of midazolam that need for the sedation remedy
the dosage of midazolam that need for sedation remedy during the mechanical ventilation
Measured: up to 24 hours
Secondary outcomes (10)
change of blood pressure
the change of blood pressure at 1 min、10 min、20 min、30 min、1 hours、2 hours、3 hours、4 hours、5 hours、6 hours、12 hours、18 hours、24 hours after the sedation drug used.
Measured: up to 24 hours.
change of heart rate
the change of heart rate at 1 min、10 min、20 min、30 min、1 hours、2 hours、3 hours、4 hours、5 hours、6 hours、12 hours、18 hours、24 hours after the sedation drug used.
Measured: up to 24 hours
change of respiratory rate
the change of respiratory rate at 1 min、10 min、20 min、30 min、1 hours、2 hours、3 hours、4 hours、5 hours、6 hours、12 hours、18 hours、24 hours after the sedation drug used.
Measured: up to 24 hours
change of blood oxygen saturation
the change of blood oxygen saturation at 1 min、10 min、20 min、30 min、1 hours、2 hours、3 hours、4 hours、5 hours、6 hours、12 hours、18 hours、24 hours after the sedation drug used.
Measured: up to 24 hours
extubation time
time from beginning of study drug used to extubation
Measured: up to 24 hours
change of hepatic function
change of blood ALT、AST level at baseline and 24 hours after the sedation drug used.
Measured: up to 24 hours
change of renal function
change of blood Cr、BUN level at baseline and 24 hours after the sedation drug used.
Measured: up to 24 hours
the dosage of sedation and analgesia drug
the total dosage of sedation and analgesia drug during the sedation and analgesia period
Measured: up to 24 hours
the number of patients requiring fentanyl analgesia in and after 6 hours from study drug used
Measured: up to 24 hours
the dosage of fentanyl in and after 6 hours from study drug used
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2014 (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 Failed Conscious Sedation During ProcedureStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuanyuan Xu, Anhui Provincial Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02296073
- Sponsor's protocol ID
- PICUDEX2014
- Status last verified
- Nov 2014
- First submitted
- 17 Nov 2014
- Last updated
- 21 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and the Safety of Dexmedetomidine Sedation on the PICU Patients-A Randomized, Controlled Study.
- ClinicalTrials.gov ID
- NCT02296073
- Acronym / sponsor ID
- PICUDEX2014
- Keywords
- Pediatric intensive care unit, Sedation, Dexmedetomidine, mechanical ventilation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Anhui Provincial Children's HospitalUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 20 Nov 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.
To observe the efficacy and safety of dexmedetomidine sedation on the patients admitted to the pediatric intensive care unit after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Midazolam | Experimental | Drug: Midazolam, Drug: Fentanyl, Other: assessmentmidazolam 3～5μg/kg•min for maintenance of sedation. |
| Dexmedetomidine1 | Experimental | Drug: Dexmedetomidine, Drug: Fentanyl, Other: assessmentDexmedetomidine 0.5μg/kg intravenous bump for 15 min，then 0.2～1.4μg/(kg.h) for maintenance of sedation； |
| Dexmedetomidine2 | Experimental | Drug: Dexmedetomidine, Drug: Fentanyl, Other: assessmentDexmedetomidine 0.25μg/kg intravenous bump for 15 min，then 0.2～1.4μg/(kg.h) for maintenance of sedation； |
| Dexmedetomiding3 | Experimental | Drug: Dexmedetomidine, Drug: Fentanyl, Other: assessmentDexmedetomidine 0.2～1.4μg/(kg.h) for maintenance of sedation； |
Who may qualify
- Ages
- 1 month to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- written informed consent；
- pediatric patients admitted to intensive care unit after general anesthesia;
- expected mechanical ventilation time >6 hours; （4）1 months to 16 years old; -
Key exclusion criteria (8 listed)
- congenital heart disease, arrhythmias and heart failure;
- Alanine transaminase（ALT） and (or) Aspartate aminotransferase（AST） level is more than twice the upper limit of normal;
- Creatinine and (or) Blood urea nitrogen（BUN） is more than the upper limit of normal;
- central nervous system disease;
- spinal analgesia or muscle relaxants is used during PICU;
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 |
|---|---|---|
| MidazolamAlso: Liyueximidazolam 3～5μg/kg•min for maintenance of sedation. | Drug | Midazolam |
| DexmedetomidineAlso: YisiDexmedetomidine 0.5μg/kg intravenous bump for 15 min，then 0.2～1.4μg/(kg.h) for maintenance of sedation； | Drug | Dexmedetomidine1 |
| DexmedetomidineAlso: YisiDexmedetomidine 0.25μg/kg intravenous bump for 15 min，then 0.2～1.4μg/(kg.h) for maintenance of sedation； | Drug | Dexmedetomidine2 |
| DexmedetomidineAlso: YisiDexmedetomidine 0.2～1.4μg/(kg.h) for maintenance of sedation； | Drug | Dexmedetomiding3 |
| FentanylAlso: FentaiFentanyl 0.5～4 μg/(kg.h) for maintenance of analgesia | Drug | Dexmedetomidine1, Dexmedetomidine2, Dexmedetomiding3, Midazolam |
| assessmentRamsay score for sedation assessment, Facial expression, leg movement, activity, cry, and consolability score (FLACC) for analgesia assessment. | Other | Dexmedetomidine1, Dexmedetomidine2, Dexmedetomiding3, Midazolam |
Primary outcome
percentage of time at target sedation score
Time frame: up to 24 hours
assess the sedation level every 2 min using Ramsay score
the number of patients requiring the sedation remedy
Time frame: up to 24 hours
the number of patients requiring the sedation remedy during the mechanical ventilation
the dosage of midazolam that need for the sedation remedy
Time frame: up to 24 hours
the dosage of midazolam that need for sedation remedy during the mechanical ventilation
10 secondary outcomes
change of blood pressure
Time frame: up to 24 hours.
change of heart rate
Time frame: up to 24 hours
change of respiratory rate
Time frame: up to 24 hours
change of blood oxygen saturation
Time frame: up to 24 hours
extubation time
Time frame: up to 24 hours
change of hepatic function
Time frame: up to 24 hours
change of renal function
Time frame: up to 24 hours
the dosage of sedation and analgesia drug
Time frame: up to 24 hours
the number of patients requiring fentanyl analgesia in and after 6 hours from study drug used
Time frame: up to 24 hours
the dosage of fentanyl in and after 6 hours from study drug used
Time frame: up to 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 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 Midazolam, Dexmedetomidine and Fentanyl in people with Failed Conscious Sedation During Procedure, run by Anhui Provincial Children's 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 3 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 Nov 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. 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?
percentage of time at target sedation score (time frame: up to 24 hours). The study lists 3 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 Nov 2014; AzTrials last refreshed its copy on 8 Nov 2026.