AnesthesiaPhase 1NCT05619627
Oral Dexmedetomidine in Pediatric MRI
A Phase 1 study testing Dexmedetomidine in people with Anesthesia, run by Soroush Merchant at 1 site in United States.
Trial summary
The objective of this preliminary study is to assess the utility of oral dexmedetomidine as the sole sedative agent in pediatric population undergoing MRI. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to Mar 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participants 3-6 years old, male and female, all races and ethnicities
- Requiring a clinically indicated MRI with general anesthesia
Who cannot join
- Refusal to take oral dexmedetomidine
- Known allergy to dexmedetomidine
- Inability to take dexmedetomidine at least 90 minutes prior to start of the MRI
- Medical contraindications to administration of dexmedetomidine including:
- Unstable cardiac status including life threatening arrhythmias, abnormal cardiac anatomy, significant cardiac dysfunction
- Current use of digoxin
Show all 17Show fewer
- Moya Moya disease
- New onset stroke
- American Society of Anesthesiologists (ASA) physical status classification > II
- Contraindications to administering sedation including:
- Active and uncontrolled gastroesophageal reflux
- Active and uncontrolled vomiting
- Current or recent history of apnea
- Active respiratory disease including pneumonia, bronchitis, respiratory syncytial virus infection, asthma exacerbation
- Craniofacial anomalies
- Inability to have MRI scans
- Non-English speaking volunteers
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Children's Mercy Hospital
Kansas City, Missouri, 64108
Soroush Merchant, MD, MS, 816-301-8595, smerchant@cmh.edu
Soroush Merchant, MD, MS
About this study
Official title: Utility of Oral Dexmedetomidine as the Sole Sedative Agent in Pediatric Population Undergoing MRI
The objective of this preliminary study is to assess the utility of oral dexmedetomidine as the sole sedative agent in pediatric population undergoing MRI.
Read the detailed description
MRI is an important and robust medical imaging technique that has become the cornerstone for radiologic studies. Superior image quality and resolution especially for soft tissue imaging, without the use of ionizing radiation, has made MRI a dominant imaging modality in pediatrics. Despite its many advantages, MRI is not child friendly. Lengthy scan times, the need for lying motionless in a confined space, excessive noise and vibration during image acquisition, are all factors that have made anesthesia an integral part of pediatric MRI.
General anesthesia is a state of medically induced unconsciousness, analgesia and muscle relaxation which is required for most invasive medical procedures. Despite being painless, MRI scans are highly susceptible to motion artifact and require a state of immobility that may not be obtainable in awake uncooperative children. While very safe, general anesthesia carries potential risk of serious morbidity and mortality secondary to aspiration during instrumentation of the airway, hypoxia and hypoventilation secondary to laryngospasm/bronchospasm and hemodynamic instability. Therefore, sedation may be an appropriate technique to offer anxiolysis, amnesia and immobility while maintaining airway reflexes with limited impact on ventilation and hemodynamics for non-stimulating procedures such as imaging. Aside from having a more favorable risk/benefit profile as compared to general anesthesia when it comes to radiologic studies, sedation is also less costly and burdensome on anesthesia departments and could provide immense cost-saving measures for healthcare institutions at large.
While there are many intravenous (IV) sedatives, establishing IV access while awake could be very traumatizing, leaving a lasting negative impression of the healthcare environment in a child's mind. Hence, enteral medications may be more acceptable and child friendly. This is especially valuable in patients who require repeated surveillance imaging and who demonstrate heightened level of anxiety and fear with each visit. Among sedative agents that could be administered enterally, dexmedetomidine may be superior due to minimal respiratory depression while providing anxiolysis and analgesia. Of note, dexmedetomidine is a highly selective alpha2-adrenoreceptor agonist that exerts its hypnotic action through activation of central pre- and postsynaptic alpha2-receptors in the locus coeruleus, mimicking natural sleep.
- Conditions
- Anesthesia
- Being tested
- Dexmedetomidine, General Anesthesia (control group)
- Keywords
- Oral dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Participants will receive oral dexmedetomidine as the sole sedative agent for undergoing MRI
General Anesthesia (control group)Drug
Participants will receive general anesthesia for their MRI
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine 4 mcg/kg | Experimental | Group One: Subjects will receive oral dexmedetomidine 4 mcg/kg 2 hours prior to MRI Receives: Drug: Dexmedetomidine |
| Dexmedetomidine 6 mcg/kg | Experimental | Group Two: Subjects will receive oral dexmedetomidine 6 mcg/kg 2 hours prior to MRI Receives: Drug: Dexmedetomidine |
| Dexmedetomidine 8 mcg/kg | Experimental | Group Three: Subjects will receive oral dexmedetomidine 8 mcg/kg 2 hours prior to MRI Receives: Drug: Dexmedetomidine |
| Dexmedetomidine 10 mcg/kg | Experimental | Group Four: Subjects will receive oral dexmedetomidine 10 mcg/kg 2 hours prior to MRI Receives: Drug: Dexmedetomidine |
| Dexmedetomidine 12 mcg/kg | Experimental | Group Five: Subjects will receive oral dexmedetomidine 12 mcg/kg 2 hours prior to MRI Receives: Drug: Dexmedetomidine |
| General anesthesia | Active comparator | Control group: Subjects will receive general anesthesia for their MRI Receives: Drug: General Anesthesia (control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral dexmedetomidine dose with adverse event below moderate risk, as designated by SIVA, to obtain adequate MRI study
The primary outcome is determining a dose of oral dexmedetomidine that will safely (adverse event (AE) below moderate risk, as designated by the World Society of Intravenous Anesthesia (SIVA) adverse sedation event reporting tool) provide adequate sedation to successfully complete an MRI. Images should have adequate quality and resolution to be interpretated and will be graded by an attending radiologist. Each MRI sequence will be graded 1-3. 1: no-mild motion artifact; 2: moderate motion artifact; 3: severe motion artifact (non-diagnostic).
Measured: From date of the first enrollment until the end of assessment of data collected from the last participant, up to 70 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start1 Nov 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies 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 1
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Prospective Pilot Study, Single-site, open-label, phase I dose escalation trial
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soroush Merchant
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Soroush Merchant, Children's Mercy Hospital Kansas City
- Investigators
- Soroush Merchant, MD, MS, Principal investigator, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05619627
- Sponsor's protocol ID
- STUDY00002526
- Status last verified
- Aug 2026
- First submitted
- 5 Oct 2022
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results
Publications
Mason KP, Roback MG, Chrisp D, Sturzenbaum N, Freeman L, Gozal D, Vellani F, Cavanaugh D, Green SM. Results from the Adverse Event Sedation Reporting Tool: A Global Anthology of 7952 Records Derived from >160,000 Procedural Sedation Encounters. J Clin Med. 2019 Dec 1;8(12):2087. doi: 10.3390/jcm8122087.
PubMed 31805686Mason KP, Green SM, Piacevoli Q; International Sedation Task Force. Adverse event reporting tool to standardize the reporting and tracking of adverse events during procedural sedation: a consensus document from the World SIVA International Sedation Task Force. Br J Anaesth. 2012 Jan;108(1):13-20. doi: 10.1093/bja/aer407.
PubMed 22157446Sajid B, Mohamed T, Jumaila M. A comparison of oral dexmedetomidine and oral midazolam as premedicants in children. J Anaesthesiol Clin Pharmacol. 2019 Jan-Mar;35(1):36-40. doi: 10.4103/joacp.JOACP_20_18.
PubMed 31057237Weerink MAS, Struys MMRF, Hannivoort LN, Barends CRM, Absalom AR, Colin P. Clinical Pharmacokinetics and Pharmacodynamics of Dexmedetomidine. Clin Pharmacokinet. 2017 Aug;56(8):893-913. doi: 10.1007/s40262-017-0507-7.
PubMed 28105598Anttila M, Penttila J, Helminen A, Vuorilehto L, Scheinin H. Bioavailability of dexmedetomidine after extravascular doses in healthy subjects. Br J Clin Pharmacol. 2003 Dec;56(6):691-3. doi: 10.1046/j.1365-2125.2003.01944.x.
PubMed 14616431Mason KP, Zurakowski D, Zgleszewski SE, Robson CD, Carrier M, Hickey PR, Dinardo JA. High dose dexmedetomidine as the sole sedative for pediatric MRI. Paediatr Anaesth. 2008 May;18(5):403-11. doi: 10.1111/j.1460-9592.2008.02468.x. Epub 2008 Mar 18.
PubMed 18363626Lin L, Guo X, Zhang MZ, Qu CJ, Sun Y, Bai J. Pharmacokinetics of dexmedetomidine in Chinese post-surgical intensive care unit patients. Acta Anaesthesiol Scand. 2011 Mar;55(3):359-67. doi: 10.1111/j.1399-6576.2010.02392.x.
PubMed 21288220Iirola T, Ihmsen H, Laitio R, Kentala E, Aantaa R, Kurvinen JP, Scheinin M, Schwilden H, Schuttler J, Olkkola KT. Population pharmacokinetics of dexmedetomidine during long-term sedation in intensive care patients. Br J Anaesth. 2012 Mar;108(3):460-8. doi: 10.1093/bja/aer441. Epub 2012 Jan 25.
PubMed 22277665Lee S, Kim BH, Lim K, Stalker D, Wisemandle W, Shin SG, Jang IJ, Yu KS. Pharmacokinetics and pharmacodynamics of intravenous dexmedetomidine in healthy Korean subjects. J Clin Pharm Ther. 2012 Dec;37(6):698-703. doi: 10.1111/j.1365-2710.2012.01357.x. Epub 2012 May 31.
PubMed 22650799Hannivoort LN, Eleveld DJ, Proost JH, Reyntjens KM, Absalom AR, Vereecke HE, Struys MM. Development of an Optimized Pharmacokinetic Model of Dexmedetomidine Using Target-controlled Infusion in Healthy Volunteers. Anesthesiology. 2015 Aug;123(2):357-67. doi: 10.1097/ALN.0000000000000740.
PubMed 26068206Potts AL, Anderson BJ, Warman GR, Lerman J, Diaz SM, Vilo S. Dexmedetomidine pharmacokinetics in pediatric intensive care--a pooled analysis. Paediatr Anaesth. 2009 Nov;19(11):1119-29. doi: 10.1111/j.1460-9592.2009.03133.x. Epub 2009 Aug 25.
PubMed 19708909Chamadia S, Pedemonte JC, Hobbs LE, Deng H, Nguyen S, Cortinez LI, Akeju O. A Pharmacokinetic and Pharmacodynamic Study of Oral Dexmedetomidine. Anesthesiology. 2020 Dec 1;133(6):1223-1233. doi: 10.1097/ALN.0000000000003568.
PubMed 32986820Dashiff CJ, Weaver M. Development and testing of a scale to measure separation anxiety of parents of adolescents. J Nurs Meas. 2008;16(1):61-80. doi: 10.1891/1061-3749.16.1.61.
PubMed 18578110Keles S, Kocaturk O. Comparison of oral dexmedetomidine and midazolam for premedication and emergence delirium in children after dental procedures under general anesthesia: a retrospective study. Drug Des Devel Ther. 2018 Mar 28;12:647-653. doi: 10.2147/DDDT.S163828. eCollection 2018.
PubMed 29636599Weldon BC, Watcha MF, White PF. Oral midazolam in children: effect of time and adjunctive therapy. Anesth Analg. 1992 Jul;75(1):51-5. doi: 10.1213/00000539-199207000-00010.
PubMed 1616162
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Oral Dexmedetomidine as the Sole Sedative Agent in Pediatric Population Undergoing MRI
- ClinicalTrials.gov ID
- NCT05619627
- Acronym / sponsor ID
- STUDY00002526
- Conditions
- Anesthesia
- Keywords
- Oral dexmedetomidine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Soroush MerchantUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 17 Nov 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.
The objective of this preliminary study is to assess the utility of oral dexmedetomidine as the sole sedative agent in pediatric population undergoing MRI.
Detailed description
MRI is an important and robust medical imaging technique that has become the cornerstone for radiologic studies. Superior image quality and resolution especially for soft tissue imaging, without the use of ionizing radiation, has made MRI a dominant imaging modality in pediatrics. Despite its many advantages, MRI is not child friendly. Lengthy scan times, the need for lying motionless in a confined space, excessive noise and vibration during image acquisition, are all factors that have made anesthesia an integral part of pediatric MRI.
General anesthesia is a state of medically induced unconsciousness, analgesia and muscle relaxation which is required for most invasive medical procedures. Despite being painless, MRI scans are highly susceptible to motion artifact and require a state of immobility that may not be obtainable in awake uncooperative children. While very safe, general anesthesia carries potential risk of serious morbidity and mortality secondary to aspiration during instrumentation of the airway, hypoxia and hypoventilation secondary to laryngospasm/bronchospasm and hemodynamic instability. Therefore, sedation may be an appropriate technique to offer anxiolysis, amnesia and immobility while maintaining airway reflexes with limited impact on ventilation and hemodynamics for non-stimulating procedures such as imaging. Aside from having a more favorable risk/benefit profile as compared to general anesthesia when it comes to radiologic studies, sedation is also less costly and burdensome on anesthesia departments and could provide immense cost-saving measures for healthcare institutions at large.
While there are many intravenous (IV) sedatives, establishing IV access while awake could be very traumatizing, leaving a lasting negative impression of the healthcare environment in a child's mind. Hence, enteral medications may be more acceptable and child friendly. This is especially valuable in patients who require repeated surveillance imaging and who demonstrate heightened level of anxiety and fear with each visit. Among sedative agents that could be administered enterally, dexmedetomidine may be superior due to minimal respiratory depression while providing anxiolysis and analgesia. Of note, dexmedetomidine is a highly selective alpha2-adrenoreceptor agonist that exerts its hypnotic action through activation of central pre- and postsynaptic alpha2-receptors in the locus coeruleus, mimicking natural sleep.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Prospective Pilot Study, Single-site, open-label, phase I dose escalation trial
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine 4 mcg/kg | Experimental | Drug: DexmedetomidineGroup One: Subjects will receive oral dexmedetomidine 4 mcg/kg 2 hours prior to MRI |
| Dexmedetomidine 6 mcg/kg | Experimental | Drug: DexmedetomidineGroup Two: Subjects will receive oral dexmedetomidine 6 mcg/kg 2 hours prior to MRI |
| Dexmedetomidine 8 mcg/kg | Experimental | Drug: DexmedetomidineGroup Three: Subjects will receive oral dexmedetomidine 8 mcg/kg 2 hours prior to MRI |
| Dexmedetomidine 10 mcg/kg | Experimental | Drug: DexmedetomidineGroup Four: Subjects will receive oral dexmedetomidine 10 mcg/kg 2 hours prior to MRI |
| Dexmedetomidine 12 mcg/kg | Experimental | Drug: DexmedetomidineGroup Five: Subjects will receive oral dexmedetomidine 12 mcg/kg 2 hours prior to MRI |
| General anesthesia | Active comparator | Drug: General Anesthesia (control group)Control group: Subjects will receive general anesthesia for their MRI |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Participants 3-6 years old, male and female, all races and ethnicities
- Requiring a clinically indicated MRI with general anesthesia
Key exclusion criteria (17 listed)
- Refusal to take oral dexmedetomidine
- Known allergy to dexmedetomidine
- Inability to take dexmedetomidine at least 90 minutes prior to start of the MRI
- Medical contraindications to administration of dexmedetomidine including:
- American Society of Anesthesiologists (ASA) physical status classification > II
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 |
|---|---|---|
| DexmedetomidineParticipants will receive oral dexmedetomidine as the sole sedative agent for undergoing MRI | Drug | Dexmedetomidine 10 mcg/kg, Dexmedetomidine 12 mcg/kg, Dexmedetomidine 4 mcg/kg, Dexmedetomidine 6 mcg/kg, Dexmedetomidine 8 mcg/kg |
| General Anesthesia (control group)Participants will receive general anesthesia for their MRI | Drug | General anesthesia |
Primary outcome
Oral dexmedetomidine dose with adverse event below moderate risk, as designated by SIVA, to obtain adequate MRI study
Time frame: From date of the first enrollment until the end of assessment of data collected from the last participant, up to 70 weeks
The primary outcome is determining a dose of oral dexmedetomidine that will safely (adverse event (AE) below moderate risk, as designated by the World Society of Intravenous Anesthesia (SIVA) adverse sedation event reporting tool) provide adequate sedation to successfully complete an MRI. Images should have adequate quality and resolution to be interpretated and will be graded by an attending radiologist. Each MRI sequence will be graded 1-3. 1: no-mild motion artifact; 2: moderate motion artifact; 3: severe motion artifact (non-diagnostic).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Background: PubMed 31805686Mason KP, Roback MG, Chrisp D, Sturzenbaum N, Freeman L, Gozal D, Vellani F, Cavanaugh D, Green SM. Results from the Adverse Event Sedation Reporting Tool: A Global Anthology of 7952 Records Derived from >160,000 Procedural Sedation Encounters. J Clin Med. 2019 Dec 1;8(12):2087. doi: 10.3390/jcm8122087.
- Background: PubMed 22157446Mason KP, Green SM, Piacevoli Q; International Sedation Task Force. Adverse event reporting tool to standardize the reporting and tracking of adverse events during procedural sedation: a consensus document from the World SIVA International Sedation Task Force. Br J Anaesth. 2012 Jan;108(1):13-20. doi: 10.1093/bja/aer407.
- Background: PubMed 31057237Sajid B, Mohamed T, Jumaila M. A comparison of oral dexmedetomidine and oral midazolam as premedicants in children. J Anaesthesiol Clin Pharmacol. 2019 Jan-Mar;35(1):36-40. doi: 10.4103/joacp.JOACP_20_18.
- Background: PubMed 28105598Weerink MAS, Struys MMRF, Hannivoort LN, Barends CRM, Absalom AR, Colin P. Clinical Pharmacokinetics and Pharmacodynamics of Dexmedetomidine. Clin Pharmacokinet. 2017 Aug;56(8):893-913. doi: 10.1007/s40262-017-0507-7.
- Background: PubMed 14616431Anttila M, Penttila J, Helminen A, Vuorilehto L, Scheinin H. Bioavailability of dexmedetomidine after extravascular doses in healthy subjects. Br J Clin Pharmacol. 2003 Dec;56(6):691-3. doi: 10.1046/j.1365-2125.2003.01944.x.
- Background: PubMed 18363626Mason KP, Zurakowski D, Zgleszewski SE, Robson CD, Carrier M, Hickey PR, Dinardo JA. High dose dexmedetomidine as the sole sedative for pediatric MRI. Paediatr Anaesth. 2008 May;18(5):403-11. doi: 10.1111/j.1460-9592.2008.02468.x. Epub 2008 Mar 18.
- Background: PubMed 21288220Lin L, Guo X, Zhang MZ, Qu CJ, Sun Y, Bai J. Pharmacokinetics of dexmedetomidine in Chinese post-surgical intensive care unit patients. Acta Anaesthesiol Scand. 2011 Mar;55(3):359-67. doi: 10.1111/j.1399-6576.2010.02392.x.
- Background: PubMed 22277665Iirola T, Ihmsen H, Laitio R, Kentala E, Aantaa R, Kurvinen JP, Scheinin M, Schwilden H, Schuttler J, Olkkola KT. Population pharmacokinetics of dexmedetomidine during long-term sedation in intensive care patients. Br J Anaesth. 2012 Mar;108(3):460-8. doi: 10.1093/bja/aer441. Epub 2012 Jan 25.
- Background: PubMed 22650799Lee S, Kim BH, Lim K, Stalker D, Wisemandle W, Shin SG, Jang IJ, Yu KS. Pharmacokinetics and pharmacodynamics of intravenous dexmedetomidine in healthy Korean subjects. J Clin Pharm Ther. 2012 Dec;37(6):698-703. doi: 10.1111/j.1365-2710.2012.01357.x. Epub 2012 May 31.
- Background: PubMed 26068206Hannivoort LN, Eleveld DJ, Proost JH, Reyntjens KM, Absalom AR, Vereecke HE, Struys MM. Development of an Optimized Pharmacokinetic Model of Dexmedetomidine Using Target-controlled Infusion in Healthy Volunteers. Anesthesiology. 2015 Aug;123(2):357-67. doi: 10.1097/ALN.0000000000000740.
- Background: PubMed 19708909Potts AL, Anderson BJ, Warman GR, Lerman J, Diaz SM, Vilo S. Dexmedetomidine pharmacokinetics in pediatric intensive care--a pooled analysis. Paediatr Anaesth. 2009 Nov;19(11):1119-29. doi: 10.1111/j.1460-9592.2009.03133.x. Epub 2009 Aug 25.
- Background: PubMed 32986820Chamadia S, Pedemonte JC, Hobbs LE, Deng H, Nguyen S, Cortinez LI, Akeju O. A Pharmacokinetic and Pharmacodynamic Study of Oral Dexmedetomidine. Anesthesiology. 2020 Dec 1;133(6):1223-1233. doi: 10.1097/ALN.0000000000003568.
- Individual participant dataSharing planned: Yes. All IPD that underlie results
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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.
Soroush Merchant, MD, MS principal investigator
Children's Mercy Hospital Kansas City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dexmedetomidine in people with Anesthesia, run by Soroush Merchant 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 2 inclusion and 17 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: opening soon, as of the sponsor's last update on 4 Aug 2026. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Soroush Merchant, MD, MS (816-3018595, smerchant@cmh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral dexmedetomidine dose with adverse event below moderate risk, as designated by SIVA, to obtain adequate MRI study (time frame: From date of the first enrollment until the end of assessment of data collected from the last participant, up to 70 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05619627, which also lists 16 linked publications.
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 4 Aug 2026.