A Phase 4 interventional study of Dexmedetomidine (IV) 0.5 mcg/kg and Propofol (IV) 2-4 mg/kg in MRI Sedation, Pediatric Sedation and Propofol Dosage, sponsored by Boston Children's Hospital. Recruiting at 1 site in United States. Open to participants aged 1 Year to 12 Years. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Boston Children's Hospital · Phase 4, Interventional, and Other
Among 82 studies testing dexmedetomidine in Emergence Delirium — 31 open to participants now, 32 under way, 3 of them phase 3. Dexmedetomidine · Emergence Delirium.
Among the 82 studies testing dexmedetomidine in Emergence Delirium, this one is the 40th largest by planned enrollment, is one of 15 that started in 2026, is one of 31 in phase 4, reaches primary completion later than 29 of the 31 other live ones, and was the 68th registered.
751 studies on the registry are indexed under Emergence Delirium; 262 are open to participants now.
Browse Emergence Delirium studies →31 of the 82 studies testing dexmedetomidine in Emergence Delirium are open now, in 11 countries. Recruiting first, the newest first:
Pakistan Institute of Medical Sciences · Sites in Pakistan
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital · Sites in Turkey
Bach Mai Hospital · Sites in Vietnam
Kasr El Aini Hospital · Sites in Egypt
Ain Shams University · Sites in Egypt
By country, each count listing its studies:
Dexmedetomidine: first FDA approval 1999 (PRECEDEX), first EMA approval 2011. What it is approved for, and how studies give it, is on its page →
Of the 143 Emergence Delirium studies recruiting now, 78 (55%) set no upper age limit and 45 (31%) stop at 75 or younger; 35 take children under 18; 25 take healthy volunteers.
This study: 1 Year to 12 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
82 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 9 · Phase 2 11 · Phase 3 13 · Phase 4 31
First in 2006; this study’s year is marked. 15 started in 2026.
This study's planned enrollment of 105 is below the median of 120 across 464 interventional studies indexed under Emergence Delirium.
Median enrollment 100 across the 82 interventional studies. Of the 37 that completed or were terminated, 10 (27%) have results posted.
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1 of 82 have an industry lead sponsor. The 10 most frequent:
Boston Children's Hospital is the lead sponsor of 608 studies on the registry; 147 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 19 (59%) have results posted.
Boston Children's Hospital has 5 studies filed under Emergence Delirium — fewer than ten, so there is no comparison to draw.
13 of the studies testing dexmedetomidine in Emergence Delirium that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07538284Phase 3Sixth Affiliated Hospital, Sun Yat-sen UniversityMInimizing Delirium With Nasal Dexmedetomidine-InducEd Sleep (MIDDIES) | 2026-12-31 |
| NCT07810556Phase 3Assiut UniversityIntrathecal Dexmedetomidine and Postoperative Delirium in Elderly Hip Fracture Surgery | 2027-10 |
| NCT07519863Ain Shams UniversityThe Effect of Dormicum-Ketamine Versus Dexmedetomidine on Emergence Delirium During Deep Sedation in Paediatric Burn Patients | 2026-11 |
| NCT07799311Pakistan Institute of Medical SciencesComparing the Efficacy of Propofol and Dexmedetomidine in Prevention of Emergence Agitation After Sevoflurane Anesthesia in Children | 2026-11-28 |
| NCT07601698Sohag UniversityDexmedetomidine vs Propofol-lidocaine Mixture in Preventing the Post Operative Emergence Agitation Following Sevoflurane Anasthesia | 2026-11-30 |
Among the 82 studies testing dexmedetomidine in Emergence Delirium, from their registry updates:
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The most common imaging procedure requiring sedation/anesthesia for the pediatric population is magnetic resonance imaging (MRI). However, the optimal anesthetic/sedation plan has not been determined for these procedures. Historically, common medications have included the use of pentobarbital and propofol, but in 2015, publication in the New England Journal of Medicine highlighted the accumulating evidence for the possible neurotoxic effects of these types of anesthetics in animal models and a collection of epidemiologic studies in humans. Although these initial possibilities have since been proven as less of a concern, in the interim, data has shown that alternative sedative agents, such as dexmedetomidine, may not have the same neurotoxic effect and could possibly even provide neuroprotection. Dexmedetomidine also possesses other beneficial traits such as reducing risks of pulmonary atelectasis or upper airway collapse, typically found with the administration of propofol.
A concern raised by previous studies has been the possibility that the addition of dexmedetomidine could increase recovery times, leading to disruptions in workflow. Although it has been shown that large doses of dexmedetomidine exposure may lead to longer PACU stays, it is uncertain whether a small dose of dexmedetomidine would have such a significant impact. Based on the investigators' pilot trial6, the investigators found that a bolus of 1 mcg/kg dose of dexmedetomidine with a bolus of titrated propofol of 2-3 mg/kg and an infusion of propofol of 100 mcg/kg/min provided adequate sedation for successful scans, reduced propofol (infusion) exposure by 60%, and did not significantly increase recovery times.
Finally, there is a paucity in literature for studies examining a range of doses subsequently; often, a control group is compared to a single, self-selected dose of choice. Here, the investigators hope to provide a range of doses to minimize selection bias in our study design and determine the dose that would provide the optimal sedation for these scans and minimize excess anesthetic exposure.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1 mg/kg (max 25 kg) of IV lidocaine (standard of care) will be given. 2-4 mg/kg titrated bolus of propofol will be administered, which can be repeated 2x until a Ramsay Sedation Score of 5-6 is achieved. After that, 250 mcg/kg/min infusion of propofol will be initiated and can be titrated up to a maximum of 300 mcg/kg/min to maintain a Ramsay Sedation Score of 5-6. If not sedated after 5 more minutes, record a technique failure and continue sedation at anesthesiologist's discretion. Per standard of care, the propofol infusion may be decreased if the blood pressure decreases by more than 30% from lowest expected norms or if there is any indication of possible airway obstruction.
Drug: Propofol (IV) 2-4 mg/kg · Drug: Propofol (IV) Infusion 250 mcg/kg/min
1 mcg/kg dexmedetomidine (DEX) bolus over 5-10 minutes will be delivered by fractionated doses or infusion. After the DEX bolus is complete, 1 mg/kg (max 25 mg) of IV lidocaine will be administered followed by a dose of 2-3 mg/kg titrated bolus of propofol (P), which can be repeated 2x until a Ramsay Sedation Score of 5-6 is achieved. After this, 150 mcg/kg/min infusion of P will be initiated. If the Ramsay Sedation score of 5-6 is not achieved within 2 minutes, 1-2 mg/kg bolus of P may be administered and P infusion will be increased to 200 mcg/kg/min. The P infusion can be titrated up to a maximum of 300 mcg/kg/min if needed to maintain a Ramsay Sedation Score of 5-6. If not sedated after 5 more minutes, record a technique failure and continue sedation at anesthesiologist's discretion. Per standard of care, the propofol infusion may be decreased if the blood pressure decreases by more than 30% from lowest expected norms or if there is any indication of possible airway obstruction.
Drug: Dexmedetomidine (IV) 1 mcg/kg · Drug: Propofol (IV) 1-2 mg/kg · Drug: Propofol (IV) Infusion 150 mcg/kg/min
0.5 mcg/kg dexmedetomidine (DEX) bolus over 5-10 minutes will be delivered by fractionated doses or infusion. After the DEX bolus is complete, 1 mg/kg (max 25 mg) of IV lidocaine will be administered followed by a dose of 2-3 mg/kg titrated bolus of propofol (P), which can be repeated 2x until a Ramsay Sedation Score of 5-6 is achieved. After this, 150 mcg/kg/min infusion of P will be initiated. If the Ramsay Sedation score of 5-6 is not achieved within 2 minutes, 1-2 mg/kg bolus of P may be administered and P infusion will be increased to 200 mcg/kg/min. The P infusion can be titrated up to a maximum of 300 mcg/kg/min if needed to maintain a Ramsay Sedation Score of 5-6. If not sedated after 5 more minutes, record a technique failure and continue sedation at anesthesiologist's discretion. Per standard of care, the propofol infusion may be decreased if the blood pressure decreases by more than 30% from lowest expected norms or if there is any indication of possible airway obstruction.
Drug: Dexmedetomidine (IV) 0.5 mcg/kg · Drug: Propofol (IV) 1-2 mg/kg · Drug: Propofol (IV) Infusion 150 mcg/kg/min
Drug page: Dexmedetomidine
If patient is randomized to the DLP arm, patient will receive an IV bolus of 0.5 mcg/kg dexmedetomidine over 5 minutes.
Also known as: Precedex
Drug page: Propofol
If patient is randomized to the P arm, patient will receive 2-4 mg/kg titrated, IV bolus of propofol until sleep is induced.
Also known as: Diprivan
Drug page: Dexmedetomidine
If patient is randomized to the DHP arm, patient will receive an IV bolus of 1 mcg/kg dexmedetomidine over 5 minutes.
Also known as: Precedex
Drug page: Propofol
If the patient is randomized to the DLP or DHP arm, following the dexmedetomidine bolus, the patient will receive a titrated, IV bolus of 1-2 mg/kg propofol.
Also known as: Diprivan
Drug page: Propofol
If the patient is randomized to the P arm, following the bolus of propofol, the patient will be started on an IV propofol infusion of 250 mcg/kg/min.
Also known as: Diprivan
Drug page: Propofol
If the patient is randomized to the DLP or DHP arm, following the titrated propofol bolus, the patient will be started on an IV propofol infusion of 150 mcg/kg/min.
Also known as: Diprivan
Total Propofol (mcg/kg/min) consumption
The total amount of propofol (mcg/kg/min) consumed will be measured for the duration of anesthesia time for the P, DLP, and DHP arms.
Time frame: Up to 120 minutes or from induction of anesthesia/sedation to end of MRI scan
Peak Pediatric Anesthesia Emergence Delirium (PAED) Score
The peak (highest) PAED score will be obtained in the post-anesthesia recovery area (PACU).
Time frame: Up to 180 minutes or duration of PACU stay
Incidence of Adverse Events
Arterial desaturation, airway obstruction, hypotension and bradycardia
Time frame: Up to 240 minutes or from induction of anesthesia/sedation to immediately during recovery
Incidences of Patient Movements/MRI Interruptions
If patient moved during their MRI and caused an interruption of the scan.
Time frame: Up to 90 minutes or duration of MRI scan
Incidence of Technique Failure
Lack of adequate sedation for MRI scan in spite of the sedation as described above (based on anesthesiologist's discretion or PSSS)
Time frame: Up to 120 minutes or from induction of anesthesia/sedation to end of MRI scan
Case Duration
Total number of minutes in the MRI scanner
Time frame: Up to 90 minutes or duration of MRI scan
Post Anesthesia Care Unit (PACU) Duration
Total number of minutes in the PACU
Time frame: Up to 180 minutes or duration of PACU stay
Ramsay Sedation Score
Average Ramsay Sedation Score
Time frame: 10 minutes or from anesthesia induction to MRI scan start
Plan to share: No
Started Jun 2026 (actual). Primary completion is estimated for Dec 2027, 18 months after the start.
Of 50 non-industry phase 4 interventional studies under Emergence Delirium, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 33. This study's planned 18 months is close to that.
Counting every sponsor, half of 50 studies reached it within 19 months; a quarter within 11 and three quarters within 33.
How these figures are worked out, and which studies are left out of them.
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Studies of the drugs tested here: Dexmedetomidine · Propofol