Evaluating the Effects of Propofol vs. Dexmedetomidine

Sedative Adverse Reaction Clinical Trial

Official title:

Evaluation of the Effects on Efficiency of a Sedation Service by Switching From Propofol to Dexmedetomidine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03552146
• Other study ID #: 17-136
• Status: Recruiting
• Start date: July 24, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: July 2019
• Source: Children's Healthcare of Atlanta
• Contact: David Fagin, MD
• Phone: 404-785-6000
• Email: david.fagin[@]pema.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Months to 36 Months

Eligibility

Inclusion Criteria:

1. Patient (or Parent/Guardian) is English speaking

2. Patient is undergoing a scheduled, elective non-contrast MRI of the brain

3. Patient is > 3 months to <36 months of age

Exclusion Criteria:

1. Patients undergoing MRI with contrast

2. Patients older than 36 months of age or younger than 3 months of age

3. Patients presenting to Emergency Department (ED) out of screening hours

4. Patients who are not English speaking

5. Patients who have history or record of propofol or dexmedetomidine allergy

6. 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.

7. Patients with unstable cardiac or respiratory status as determined by treating attending physician

8. Patients who are receiving digoxin

Related Conditions & MeSH terms

• Sedative Adverse Reaction

Intervention

Drug:
• Propofol
Patients will be randomized to either propofol or dexmedetomidine and then observed for sedation-related events from time of drug administration to discharge.
• Dexmedetomidine
Patients will be randomized to either propofol or dexmedetomidine and then observed for sedation-related events from time of drug administration to discharge.

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Children's Healthcare of Atlanta	Morehouse School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Post-discharge clinical status	Recording any events post-discharge that are possibly sedation-related	Baseline to 24 hours post discharge
Primary	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).	Start of procedure to discharge (up to 8 hours)
Secondary	Sedation related events	Adverse events related to the sedation (i.e., apnea, desaturation, change in heart rate)	Start of procedure to up to 36 hours post-discharge