DexmedetomidinePhase 3PROMISENCT05485519
Prospective, Randomized, Open Label Controlled Trial To Evaluate The Safety And Efficacy Of Dexmedetomidine Use Beyond 24 Hours Compared With Midazolam In Children Admitted To Pediatric Intensive Care Unit at King Abdullah Specialist Children Hospital- Ministry of National Guard Health Affairs.
A Phase 3 study testing Dexmedetomidine and Midazolam in people with Dexmedetomidine and Midazolam, run by King Abdullah International Medical Research Center at 1 site in Saudi Arabia.
Trial summary
Study will be conducted in Pediatric Intensive Care Unit (PICU) in King Abdullah Specialist Children Hospital (KASCH), National Guard Health Affairs, Riyadh, Saudi Arabia. Total of 430 patients will participate to assess the safety and efficacy of prolonged Dexmedetomidine use beyond 24 hours in pediatric Intensive… Read more about this study
- Who is it for?
- Ages 1 year to 14 years
- Conditions the study is for
- Dexmedetomidine, Midazolam, Withdrawal Symptoms
- What is being tested?
- Dexmedetomidine and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 21 Apr 2022to May 2024
- 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 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 1-14 years both male and female who require mechanical ventilation
- Informed consent from signed by patient's legal representatives, and for patients aged 12- 14 who has an age-appropriate understanding additional assent form signed by patient is required.
- Intubated within 6 hours and anticipated to require mechanical ventilation for more than 48 hours
Who cannot join
- Septic shock and/or multi-organ failure.
- Hemodynamically instability and requires inotropes.
- Severe intracranial or spinal trauma with high intracranial pressure
- Liver failure
- Acute or chronic renal failure.
- Glasgow Coma Scale (GCS) ≤8
- Known to have allergy to the study drugs
- Airway surgery
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
King Abdullah Specialist Children Hospital (KASCH)
Riyadh, 14611
Majed Jeraisy, 0504192291, JeraisyM@MNGHA.MED.SA
Majed A Jeraisy
About this study
Official title: Prospective, Randomized, Open Label Controlled Trial To Evaluate The Safety And Efficacy Of Dexmedetomidine Use Beyond 24 Hours Compared With Midazolam In Children Admitted To Pediatric Intensive Care Unit (PICU) at KASCH-MNGHA.
Study will be conducted in Pediatric Intensive Care Unit (PICU) in King Abdullah Specialist Children Hospital (KASCH), National Guard Health Affairs, Riyadh, Saudi Arabia. Total of 430 patients will participate to assess the safety and efficacy of prolonged Dexmedetomidine use beyond 24 hours in pediatric Intensive Care Unite.
Read the detailed description
Prospective, randomized, open label, controlled study, will be conducted in Pediatric Intensive Care Unit (PICU) in King Abdullah Specialist Children Hospital (KASCH), National Guard Health Affairs, Riyadh, Saudi Arabia. 340 patients will be randomly randomized to Midazolam (M) or Dexmedetomidine (D), to assess the safety and efficacy of prolonged Dexmedetomidine use beyond 24 hours.
- Conditions
- Dexmedetomidine, Midazolam, Withdrawal Symptoms, Failure of Extubation
- Being tested
- Dexmedetomidine, Midazolam
- Keywords
- Dexmedetomidine, Midazolam, Intubation, Withdrawal Symptoms, failure of Extubating
- Medical subject headings
- Substance Withdrawal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Infusion start at 0.5 mcg/kg/hour. Titrate to effect (up to1.5 mcg/kg/hour)
MidazolamDrug
(1 mcg/kg/minute. up to a maximum of 5 mcg/kg/minute.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine (D) | Experimental | Infusion start at 0.5 mcg/kg/hour. Titrate to effect (up to1.5 mcg/kg/hour) Receives: Drug: Dexmedetomidine |
| Midazolam (M) | Active comparator | 1 mcg/kg/minute. Up to a maximum of 5 mcg/kg/minute. Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean time taken from end of sedation to extubation with no or minimal withdrawal symptoms
Measured: from end of sedation to extubation assessed up to 24 hrs
Secondary outcomes (1)
To compare length of PICU stay in both groups
Measured: from Intubation to discharge assessed up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start21 Apr 2022
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DexmedetomidineStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 430 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdullah International Medical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05485519
- Sponsor's protocol ID
- RC20/160/R
- Acronym
- PROMISE
- Status last verified
- Apr 2023
- First submitted
- 30 Jun 2022
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Open Label Controlled Trial To Evaluate The Safety And Efficacy Of Dexmedetomidine Use Beyond 24 Hours Compared With Midazolam In Children Admitted To Pediatric Intensive Care Unit (PICU) at KASCH-MNGHA.
- ClinicalTrials.gov ID
- NCT05485519
- Acronym / sponsor ID
- PROMISE / RC20/160/R
- Conditions
- Dexmedetomidine, Midazolam, Withdrawal Symptoms, Failure of Extubation
- Keywords
- Dexmedetomidine, Midazolam, Intubation, Withdrawal Symptoms, failure of Extubating
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 430 participants (estimated)
- Lead sponsor
- King Abdullah International Medical Research CenterUniversity, hospital or other
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 3 Aug 2022 (actual)
- 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.
Study will be conducted in Pediatric Intensive Care Unit (PICU) in King Abdullah Specialist Children Hospital (KASCH), National Guard Health Affairs, Riyadh, Saudi Arabia. Total of 430 patients will participate to assess the safety and efficacy of prolonged Dexmedetomidine use beyond 24 hours in pediatric Intensive Care Unite.
Detailed description
Prospective, randomized, open label, controlled study, will be conducted in Pediatric Intensive Care Unit (PICU) in King Abdullah Specialist Children Hospital (KASCH), National Guard Health Affairs, Riyadh, Saudi Arabia. 340 patients will be randomly randomized to Midazolam (M) or Dexmedetomidine (D), to assess the safety and efficacy of prolonged Dexmedetomidine use beyond 24 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine (D) | Experimental | Drug: DexmedetomidineInfusion start at 0.5 mcg/kg/hour. Titrate to effect (up to1.5 mcg/kg/hour) |
| Midazolam (M) | Active comparator | Drug: Midazolam1 mcg/kg/minute. Up to a maximum of 5 mcg/kg/minute. |
Who may qualify
- Ages
- 1 year to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 1-14 years both male and female who require mechanical ventilation
- Informed consent from signed by patient's legal representatives, and for patients aged 12- 14 who has an age-appropriate understanding additional assent form signed by patient is required.
- Intubated within 6 hours and anticipated to require mechanical ventilation for more than 48 hours
Key exclusion criteria (8 listed)
- Septic shock and/or multi-organ failure.
- Hemodynamically instability and requires inotropes.
- Severe intracranial or spinal trauma with high intracranial pressure
- Liver failure
- Acute or chronic renal failure.
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 |
|---|---|---|
| DexmedetomidineInfusion start at 0.5 mcg/kg/hour. Titrate to effect (up to1.5 mcg/kg/hour) | Drug | Dexmedetomidine (D) |
| Midazolam(1 mcg/kg/minute. up to a maximum of 5 mcg/kg/minute. | Drug | Midazolam (M) |
Primary outcome
Mean time taken from end of sedation to extubation with no or minimal withdrawal symptoms
Time frame: from end of sedation to extubation assessed up to 24 hrs
1 secondary outcome
To compare length of PICU stay in both groups
Time frame: from Intubation to discharge assessed up to 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
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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.
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 and Midazolam in people with Dexmedetomidine and Midazolam, run by King Abdullah International Medical Research Center at 1 site in Saudi Arabia.
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 27 Apr 2023. 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 Saudi Arabia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Majed A Jeraisy (+966-504192291 ext. 94455, jjeraisym@ngha.med.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean time taken from end of sedation to extubation with no or minimal withdrawal symptoms (time frame: from end of sedation to extubation assessed up to 24 hrs). 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 27 Apr 2023.