Propofol vs Dexmedetomidine for Anesthesia

(ICHOR Trial)

Overseen By Hannah Wiseman

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Children's Hospital Los Angeles

Must not be taking: QT prolonging drugs

Disqualifiers: MRI-incompatible devices, Preterm infants, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: Approximately 60 minutes

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two types of anesthesia, Propofol and Dexmedetomidine, to assess their effects on blood flow and oxygen use in the brain during MRI scans. Researchers seek to determine any differences in how these anesthetics impact brain function. Participants will be randomly assigned to receive either Propofol or Dexmedetomidine. This trial may suit children up to 7 years old who require anesthesia for an MRI and have no conditions affecting brain blood flow or oxygen use. As a Phase 4 trial, this research helps clarify how these FDA-approved anesthetics can benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for these treatments?

Research has shown that both Propofol and Dexmedetomidine are commonly used and generally safe for sedation during procedures like MRIs. Studies indicate that Dexmedetomidine provides effective sedation and usually does not cause breathing problems, even at higher doses. It has been safely used in children undergoing MRIs, with many reaching the needed sedation level quickly.

Propofol is another widely used sedative. Research involving children found it to be safe and effective, but monitoring for possible breathing issues is important. One study noted that while Propofol sedation is generally safe, it can sometimes lead to atelectasis, a partial collapse of the lung.

Both drugs have well-documented safety records and are regularly used in medical settings. However, careful monitoring during use is essential to ensure safety. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments because Dexmedetomidine and Propofol offer distinct approaches for anesthesia during MRI procedures. Dexmedetomidine stands out because it provides sedation while preserving respiratory function, a significant advantage over traditional anesthetics that may depress breathing. On the other hand, Propofol is well-known for its rapid onset and recovery times, making it a preferred choice for short procedures. Both drugs are administered via continuous infusion, allowing for precise control over sedation levels, which can enhance patient safety and comfort during imaging.

What evidence suggests that this trial's treatments could be effective for cerebral blood flow and oxygen metabolism?

This trial will compare Propofol and Dexmedetomidine for anesthesia during MRI procedures. Research has shown that Propofol reliably sedates patients in various medical procedures, achieving a high success rate of 95.9% in completing procedures and offering faster recovery times compared to other drugs. It is known for its safe use in both adults and children.

Dexmedetomidine, which participants in another arm of this trial may receive, is another strong option. Studies have demonstrated that it improves recovery quality and reduces long-term pain after surgery. While it can sometimes cause a slower heart rate or low blood pressure, it has been proven to decrease issues like confusion and the need for breathing support. Both treatments are widely used and have their own strengths in anesthesia. ^{6 7 8 9 10}

Who Is on the Research Team?

Matthew Borzage, PhD

Principal Investigator

Children's Hospital Los Angeles

Are You a Good Fit for This Trial?

This trial is for children from birth to 7 years old needing anesthesia for an MRI, without conditions affecting brain oxygen or blood flow. Excluded are those with sensitivity to certain anesthetics, incompatible implants, unstable health, no need for anesthesia during MRI, preterm infants under 25 weeks PMA, or at risk of propofol infusion syndrome.

Inclusion Criteria

Patients with conditions not believed to alter oxygen metabolism or blood flow in the brain, including but not limited to patients with orthopedic indications, undescended testicles, hernia repairs, term equivalent age scans

I am 7 years old or younger.

I have a condition that affects oxygen use or blood flow in my brain.

Exclusion Criteria

I am at risk of heart rhythm problems from certain anesthesia due to a genetic condition or medications I'm taking.

My baby was born before 25 weeks of pregnancy and is still under that age.

Patients with an MRI-incompatible device or implant (e.g. pacemakers, stents)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Propofol or Dexmedetomidine anesthesia during their MRI

Approximately 60 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dexmedetomidine
• Propofol

Trial Overview The ICHOR 4 study compares the effects of two anesthetics—Propofol and Dexmedetomidine—on cerebral blood flow and oxygen metabolism in young patients undergoing MRI. Participants will be randomly assigned one of these drugs to see how each affects hemodynamic responses.

How Is the Trial Designed?

Group I: Propofol Experimental Treatment 1 Intervention

Subject will receive propofol anesthesia during their MRI. Dosage form: injectable solution. Dosage: 100-300 mcg/kg/min, or as per clinical standard of care appropriate for specific subjects. Frequency and duration: continuous infusion while undergoing MRI.

Group II: Dexmedetomidine Experimental Treatment 1 Intervention

Subject will receive Dexmedetomidine during their MRI. Dosage form: injectable solution. Dosage: Generally, initiate at 0.6 mcg/kg/hour and titrate to achieve desired clinical effect with dosages ranging from 0.2 to 1 mcg/kg/hour or as per clinical standard of care appropriate for specific subjects. Frequency and duration: continuous infusion while undergoing MRI.

Who Is Running the Clinical Trial?

Children's Hospital Los Angeles

Lead Sponsor

Trials

257

Recruited

5,075,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39019769/

Effectiveness of dexmedetomidine on patient-centred ... Compared with placebo or standard of care, intraoperative dexmedetomidine likely results in meaningful improvement in the quality of recovery and chronic pain ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0007091224003465

Effectiveness of dexmedetomidine on patient-centred ... Intraoperative dexmedetomidine likely results in meaningful improvement in the quality of recovery and chronic pain after surgery.

3. frontiersin.org frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2023.1241714/full

Efficacy and safety of sedation with dexmedetomidine in ... This meta-analysis indicates that DEX is a safe and effective sedative agent for gastrointestinal endoscopy because of its benefits for patients in some ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39394067/

The 95% effective dose of dexmedetomidine to induce ... Conclusions: The 95% effective dose of dexmedetomidine to induce adequate sedation in patients with chronic insomnia disorder was 1.75 µg/kg.

5. healthcare-bulletin.co.uk healthcare-bulletin.co.uk/article/efficacy-of-dexmedetomidine-in-sedation-general-and-spinal-anesthesia-a-clinical-evaluation-3478/

Efficacy of Dexmedetomidine in Sedation, General, and ... Although there is a higher risk of bradycardia and hypotension, a meta-analysis of 16 RCTs (n=1,994) verified that it can decrease delirium, ventilation time, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9331356/

Safety of Dexmedetomidine as an Alternative Pediatric ... Our data indicate that 44 patients (51%) out of 87 reached a deep level of sedation (RASS-4) before 10 min.

7. publications.aap.org publications.aap.org/hospitalpediatrics/article/9/5/348/26752/Safety-and-Efficacy-of-Buccal-Dexmedetomidine-for

Safety and Efficacy of Buccal Dexmedetomidine for MRI ... In this retrospective study of school-aged children undergoing sedated outpatient MRI, we report satisfactory sedation in 81.4% of children ...

8. oncotarget.com oncotarget.com/article/22271/text/

Dexmedetomidine versus propofol on the sedation of ... Dexmedetomidine and propofol are both commonly used sedatives in children undergoing MRI examination for their efficacy and safety [5, 17].

9. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/pan.14857

A randomized, double‐blind, dose‐controlled study of the ... This study was undertaken to evaluate efficacy and safety of dexmedetomidine for MRI sedation of children between 1 month and 17 years of age.

10. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0277032607000621

Sedation and anesthesia for magnetic resonance imaging ... Dexmedetomidine is an excellent sedative, has analgesic properties, and appears to be clinically safe from a respiratory point of view even at high doses, ...