Dexmedetomidine for Respiratory Impairment

(SPICEIV Trial)

Overseen By Jose Estrada

Age: 65+

Sex: Any

Trial Phase: Phase 4

Sponsor: St. Joseph's Healthcare Hamilton

Must not be taking: Neuromuscular blockers

Disqualifiers: Brain injury, Spinal injury, Drug overdose, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Duration of mechanical ventilation (expected more than one day)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests dexmedetomidine, a sedative, to determine if it helps people in intensive care on breathing machines feel more comfortable and safe. The aim is to find out if this medication reduces anxiety and distress more effectively than a placebo (a harmless, inactive treatment). The trial specifically targets individuals aged 65 or older who are intubated and require ongoing sedation while on a ventilator. As a Phase 4 trial, this research seeks to understand how this already FDA-approved and effective treatment can benefit more patients.

Do I need to stop my current medications for the trial?

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 dexmedetomidine?

Research has shown that dexmedetomidine is generally safe for sedation. Studies have found that it does not significantly affect breathing or oxygen use, making it less likely to cause breathing problems than some other sedatives.

However, dexmedetomidine can cause side effects. Common ones include a slow heart rate, low blood pressure, and restlessness. In rare cases, more serious heart issues, such as cardiac arrest, have been reported.

Compared to midazolam, another sedative, dexmedetomidine poses a lower risk of breathing problems. It also appears to reduce the need for a breathing tube, indicating a positive safety profile.

Overall, dexmedetomidine is considered safe for sedation, especially with proper monitoring. Discuss any concerns with healthcare providers before joining a clinical trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard of care for respiratory impairment, which often includes treatments like supplemental oxygen or mechanical ventilation, dexmedetomidine offers a unique approach by acting as a selective alpha-2 adrenergic agonist. This mechanism provides sedation without the respiratory depression typically associated with other sedatives. Researchers are excited about dexmedetomidine because it could maintain patient comfort and safety by allowing for sedation while minimizing the risk of worsening respiratory function. Additionally, its ability to provide sedation with a potential for quicker recovery could make it a valuable option in managing respiratory impairment effectively.

What evidence suggests that dexmedetomidine might be an effective treatment for respiratory impairment?

In this trial, participants in the experimental arm will receive dexmedetomidine, a sedative that research has shown to be effective for patients requiring mechanical ventilation. Studies have found that dexmedetomidine causes fewer breathing issues compared to other sedatives like propofol. Additionally, it has been linked to lower hospital mortality rates due to its ability to improve blood oxygen levels and reduce inflammation. Compared to benzodiazepines, dexmedetomidine also leads to better patient outcomes. Overall, evidence supports its use as a safer and effective option for sedation in critically ill patients. Participants in the control arm will receive a placebo. ^{1 6 7 8 9}

Who Is on the Research Team?

Kimberley Lewis, MD

Principal Investigator

St. Joseph's Healthcare Hamilton/McMaster University

Are You a Good Fit for This Trial?

This trial is for patients aged 65 or older who are intubated and on mechanical ventilation in an ICU, expected to remain so at least until the day after tomorrow, and need ongoing sedation for comfort and safety.

Inclusion Criteria

My doctor expects me to need breathing support for at least two more days.

I am 65 years old or older.

I am on a breathing machine in the ICU.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive early sedation with dexmedetomidine or placebo while mechanically ventilated

Duration of mechanical ventilation (expected more than one day)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including 90-day all-cause mortality and 28-day major adverse kidney events

90 days

What Are the Treatments Tested in This Trial?

Interventions

• Dexmedetomidine
• Placebo

Trial Overview The study tests whether early sedation with Dexmedetomidine improves patient outcomes compared to a placebo. It aims to determine best practices for sedating critically ill ventilated patients.

How Is the Trial Designed?

Group I: Dexmedetomidine Intervention Experimental Treatment 1 Intervention

Patients randomized to the experimental arm will receive dexmedetomidine. The study medication will be reconstituted by mixing 4 vials (8 ml) into a 100 ml bag of normal saline or 5% dextrose, this is the preferred dilution, or 2 vials (4ml) into 50 ml syringe to an equivalent concentration of 8 mcg/ml of dexmedetomidine. The constituted infusion is stable at room temperature for up to 24 hours. The recommended starting infusion rate is equivalent to 1 µg/kg/h of dexmedetomidine, without loading or bolus. This will be titrated to an equivalent dexmedetomidine dose of 0 to 1.0 µg/kg/h according to study algorithm to maintain target sedation of Richmond Agitation-Sedation Scale (RASS) score of -1 to +1.

Group II: Control Intervention Placebo Group 1 Intervention

Those in the control group will receive a placebo that is identical in colour and packaging and at equal volume to the intervention group. The placebo is a matching vial containing 2 mL sterile normal saline.

Who Is Running the Clinical Trial?

St. Joseph's Healthcare Hamilton

Lead Sponsor

Trials

203

Recruited

26,900+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC29047/

Respiratory effects of dexmedetomidine in the surgical patient ... The present results show that dexmedetomidine appears to have no clinically important adverse effects on respiratory rate and gas exchange when used in ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0278239120304821

Dexmedetomidine Provides Fewer Respiratory Events ... DEX is known to cause less respiratory depression than PRO,23,24 and hypercapnia was significantly more frequent in PRO group patients than DEX group patients ...

3. bmcanesthesiol.biomedcentral.com bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-025-02961-y

Dexmedetomidine administration is associated with reduced ... Intravenous administration of DEX was associated with reduced in-hospital mortality, at least in part, by ameliorating ABG indices and inflammatory mediators.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39552466/

A Multicentre Cohort Study Conclusion: Dexmedetomidine did not appear to lower the risk of respiratory failure necessitating invasive mechanical ventilation in critically ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa2024922

Dexmedetomidine or Propofol for Sedation in Mechanically ... Trials comparing dexmedetomidine with benzodiazepines in adults have shown that the use of dexmedetomidine results in improvement in outcomes ...

6. frontiersin.org frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2024.1419196/full

Dexmedetomidine: a real-world safety analysis based on ... The common adverse events of Dexmedetomidine include bradycardia, cardiac arrest, hypotension, diabetes insipidus, arteriospasm coronary and agitation.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2210740124000366

Safety and efficacy of dexmedetomidine vs. midazolam in ... In comparison to the midazolam group, dexmedetomidine administration was associated with a reduced risk of respiratory depression (RR=0.25, 95 %CI: 0.11–0.56) ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8579314/

Safety and Efficacy of Dexmedetomidine in Acutely Ill Adults ... The use of dexmedetomidine, compared with other sedation strategies or placebo, reduced the risk of intubation (RR, 0.54; 95% CI, 0.41-0.71; moderate certainty) ...

9. mdpi.com mdpi.com/1648-9144/61/4/726

A Meta-Analysis of Randomized Controlled Trials The results indicate that remimazolam is as safe as dexmedetomidine regarding respiratory depression during sedation.