Sedative Adverse ReactionNCT03552146
Evaluating the Effects of Propofol vs. Dexmedetomidine
An observational study of Sedative Adverse Reaction, run by Children's Healthcare of Atlanta at 1 site in United States.
Trial summary
The primary purpose of this observational study is to compare what drugs work best in sedating children (> 3 months to < 36 months) who need an MRI. This type of research may help clinicians (healthcare providers) learn more about how dexmedetomidine works compared to propofol. Read more about this study
- Who is it for?
- Ages 3 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Sedative Adverse Reaction
- What is being tested?
- Propofol and Dexmedetomidine
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2018to 30 Sep 2019
- Phase
- Observational
- 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 3 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study will draw from children who are scheduled for non emergent sedation to undergo a brain non contrast, magnetic resonance imaging (MRI) study. Children are otherwise healthy and fall within the age span of 3 months to 36 months. This is an observational study of the outcomes outlined, when patients agree to be randomized to either of 2 drugs which are FDA approved to provide optimal sedation for this MRI procedure.
Who may be able to join
- Patient (or Parent/Guardian) is English speaking
- Patient is undergoing a scheduled, elective non-contrast MRI of the brain
- Patient is > 3 months to <36 months of age
Who cannot join
- Patients undergoing MRI with contrast
- Patients older than 36 months of age or younger than 3 months of age
- Patients presenting to Emergency Department (ED) out of screening hours
- Patients who are not English speaking
- Patients who have history or record of propofol or dexmedetomidine allergy
- Patients with known or history of anaphylaxis to eggs, egg products, soybeans, or soy based products; if patient has a history of a hypersensitivity reaction associated with exposure to eggs, egg products, soybeans, or soy based products, approval must be given by the treating attending physician and documented on the patient's medical record.
- Patients with unstable cardiac or respiratory status as determined by treating attending physician
- Patients who are receiving digoxin
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Children's Healthcare of Atlanta
Atlanta, Georgia, 30342
About this study
Official title: Evaluation of the Effects on Efficiency of a Sedation Service by Switching From Propofol to Dexmedetomidine
The primary purpose of this observational study is to compare what drugs work best in sedating children (> 3 months to < 36 months) who need an MRI. This type of research may help clinicians (healthcare providers) learn more about how dexmedetomidine works compared to propofol. The investigators are planning to have 60 children complete the study at Children's Healthcare of Atlanta at Scottish Rite. Half (30) of the patients will be randomized to receive dexmedetomidine and the other half will receive propofol. (Both drugs are licensed and approved for the sedation performed for consented patients.)
Read the detailed description
There are several different medications commonly being used to facilitate the administration of radiologic procedures on children. Procedures such as Magnetic Resonance Imaging (MRIs) require that the patient remain still for the duration of the test. Propofol has become the drug of choice for many sedation services due to its rapid onset of action, rapid recovery time, ability to achieve sedation reliably and favorable safety profile. Dexmedetomidine, a selective alpha-2- adrenergic agonist, has also gained popularity with sedation services. Its main advantage over propofol is that it has minimal respiratory complications when compared to propofol. The sedative effect from dexmedetomidine preserves a natural sleep pattern and induces cooperative sedation in which patients are easily arousable. In pediatric studies, the most frequent adverse effect have been related to its potential to cause hypotension and bradycardia, which resolve with dose reduction. Additionally, dexmedetomidine does not seem to have as much impairment of cognitive function and has an opioid sparing effect. Dexmedetomidine, however, has a longer onset of action and longer recovery time compared to propofol, which has limited its use with many sedation services.
- Conditions
- Sedative Adverse Reaction
- Being tested
- Propofol, Dexmedetomidine
- Keywords
- sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called Diprivan
Patients will be randomized to either propofol or dexmedetomidine and then observed for sedation-related events from time of drug administration to discharge.
DexmedetomidineDrug
Also called Precedex
Patients will be randomized to either propofol or dexmedetomidine and then observed for sedation-related events from time of drug administration to discharge.
| Study group | Role | What they receive |
|---|---|---|
| Sedation Group 1 | Patients will receive standard of care dose of Propofol, based on the provider's assessment, prior to radiologic procedure. Receives: Drug: Propofol | |
| Sedation Group 2 | Patients will receive standard of care dose of dexmedetomidine, based on the provider's assessment, prior to radiologic procedure. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural times to achieve optimal sedation
Measuring the amount of time it takes for a patient to be discharged starting from induction (start of infusion).
Measured: Start of procedure to discharge (up to 8 hours)
Secondary outcomes (1)
Sedation related events
Adverse events related to the sedation (i.e., apnea, desaturation, change in heart rate)
Measured: Start of procedure to up to 36 hours post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study start24 Jul 2018
- Primary completion30 Sep 2019 (estimated)
- Study completion30 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedative Adverse ReactionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Healthcare of Atlanta
- Sponsor type
- University, hospital or other
- Collaborators
- Morehouse School of Medicine
- Responsible party
- Principal investigator, David Fagin, MD, Children's Healthcare of Atlanta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03552146
- Sponsor's protocol ID
- 17-136
- Status last verified
- Jul 2019
- First submitted
- 30 Mar 2018
- Last updated
- 24 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This is a pilot study of observations made of patients who are randomized to receive 1 of 2 sedation medications, which are currently FDA approved for the proposed study. The data will help researchers determine the feasibility to conduct a large scale multi-center study to look specifically at primary outcomes as outlined in the proposal.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects on Efficiency of a Sedation Service by Switching From Propofol to Dexmedetomidine
- ClinicalTrials.gov ID
- NCT03552146
- Acronym / sponsor ID
- 17-136
- Conditions
- Sedative Adverse Reaction
- Keywords
- sedation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Children's Healthcare of AtlantaUniversity, hospital or other
- Collaborators
- Morehouse School of Medicine
- Study start
- 24 Jul 2018 (actual)
- Primary completion
- 30 Sep 2019 (estimated)
- Study completion
- 30 Sep 2019 (estimated)
- First posted
- 11 Jun 2018 (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.
The primary purpose of this observational study is to compare what drugs work best in sedating children (> 3 months to < 36 months) who need an MRI. This type of research may help clinicians (healthcare providers) learn more about how dexmedetomidine works compared to propofol. The investigators are planning to have 60 children complete the study at Children's Healthcare of Atlanta at Scottish Rite. Half (30) of the patients will be randomized to receive dexmedetomidine and the other half will receive propofol. (Both drugs are licensed and approved for the sedation performed for consented patients.)
Detailed description
There are several different medications commonly being used to facilitate the administration of radiologic procedures on children. Procedures such as Magnetic Resonance Imaging (MRIs) require that the patient remain still for the duration of the test. Propofol has become the drug of choice for many sedation services due to its rapid onset of action, rapid recovery time, ability to achieve sedation reliably and favorable safety profile. Dexmedetomidine, a selective alpha-2- adrenergic agonist, has also gained popularity with sedation services. Its main advantage over propofol is that it has minimal respiratory complications when compared to propofol. The sedative effect from dexmedetomidine preserves a natural sleep pattern and induces cooperative sedation in which patients are easily arousable. In pediatric studies, the most frequent adverse effect have been related to its potential to cause hypotension and bradycardia, which resolve with dose reduction. Additionally, dexmedetomidine does not seem to have as much impairment of cognitive function and has an opioid sparing effect. Dexmedetomidine, however, has a longer onset of action and longer recovery time compared to propofol, which has limited its use with many sedation services.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sedation Group 1 | – | Drug: PropofolPatients will receive standard of care dose of Propofol, based on the provider's assessment, prior to radiologic procedure. |
| Sedation Group 2 | – | Drug: DexmedetomidinePatients will receive standard of care dose of dexmedetomidine, based on the provider's assessment, prior to radiologic procedure. |
Who may qualify
- Ages
- 3 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study will draw from children who are scheduled for non emergent sedation to undergo a brain non contrast, magnetic resonance imaging (MRI) study. Children are otherwise healthy and fall within the age span of 3 months to 36 months. This is an observational study of the outcomes outlined, when patients agree to be randomized to either of 2 drugs which are FDA approved to provide optimal sedation for this MRI procedure.
Key inclusion criteria (3 listed)
- Patient (or Parent/Guardian) is English speaking
- Patient is undergoing a scheduled, elective non-contrast MRI of the brain
- Patient is > 3 months to <36 months of age
Key exclusion criteria (8 listed)
- Patients undergoing MRI with contrast
- Patients older than 36 months of age or younger than 3 months of age
- Patients presenting to Emergency Department (ED) out of screening hours
- Patients who are not English speaking
- Patients who have history or record of propofol or dexmedetomidine allergy
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 |
|---|---|---|
| PropofolAlso: DiprivanPatients will be randomized to either propofol or dexmedetomidine and then observed for sedation-related events from time of drug administration to discharge. | Drug | Sedation Group 1 |
| DexmedetomidineAlso: PrecedexPatients will be randomized to either propofol or dexmedetomidine and then observed for sedation-related events from time of drug administration to discharge. | Drug | Sedation Group 2 |
Primary outcome
Procedural times to achieve optimal sedation
Time frame: Start of procedure to discharge (up to 8 hours)
Measuring the amount of time it takes for a patient to be discharged starting from induction (start of infusion).
1 secondary outcome
Sedation related events
Time frame: Start of procedure to up to 36 hours post-discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
- Individual participant dataSharing planned: Undecided. This is a pilot study of observations made of patients who are randomized to receive 1 of 2 sedation medications, which are currently FDA approved for the proposed study. The data will help researchers determine the feasibility to conduct a large scale multi-center study to look specifically at primary outcomes as outlined in the proposal.
Related trials for Sedative Adverse Reaction
Not yet recruitingObservational study
Effect of Circadian Rhythm on the Sedative Efficacy and Recovery Quality of Ciprofol General Anesthesia: A Multi-Center Observational Study
Circadian Rhythm, Ciprofol
RecruitingPhase 4
Evaluation of Ketamine as Sedative Agent in Endoscopic Retrograde Cholangiopancreatography (ERCP)
Ketamine Adverse Reaction
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?
An observational study of Sedative Adverse Reaction, run by Children's Healthcare of Atlanta at 1 site in United States.
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 24 Jul 2019. 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 United States. 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.
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 David Fagin, MD (404-785-6000, david.fagin@pema.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural times to achieve optimal sedation (time frame: Start of procedure to discharge (up to 8 hours)). 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 24 Jul 2019.