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Fentanyl Effect on Blood Pressure in Elderly Patients After Induction of General Anesthesia (Fentanyl Trial)
Phase 2 & 3
Waitlist Available
Led By Jeffrey Hartwig, MD
Research Sponsored by Loyola University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 60 minutes following dose administration
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
Summary
This trial will test whether or not fentanyl contributes to hypotension (low blood pressure) during the induction of general anesthesia in elderly patients. If fentanyl is found to contribute to hypotension, the study may lead to a change in clinical practice which could improve patient outcomes and mortality rates.
Eligible Conditions
- Low Blood Pressure
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 60 minutes following dose administration
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 60 minutes following dose administration
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Development of hypotension
Side effects data
From 2009 Phase 4 trial • 237 Patients • NCT01795898100%
Aneurysm ruptured
54%
Dizziness
39%
Nausea
26%
Vomiting
16%
Somnolence
5%
Pruritus
2%
Insomnia
2%
Headache
1%
Weakness
1%
Palpitation
1%
Rashes
1%
Chest pain
1%
Cold clammy perspiration
1%
Flushing
1%
Muscle trembling
1%
Constipation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fentanyl
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Low DoseExperimental Treatment1 Intervention
Individuals assigned to this condition will receive 1 mcg/kg fentanyl
Group II: High DoseExperimental Treatment1 Intervention
Individuals assigned to this condition will receive 2 mcg/kg fentanyl
Group III: ControlPlacebo Group1 Intervention
Individuals assigned to this condition will receive 0.9 mcg/kg sodium chloride (NaCL)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fentanyl
FDA approved
Find a Location
Who is running the clinical trial?
Loyola UniversityLead Sponsor
160 Previous Clinical Trials
31,351 Total Patients Enrolled
Jeffrey Hartwig, MDPrincipal Investigator - Loyola University Chicago
Loyola University Medical Center
Chicago College Of Osteopathic Medicine (Medical School)
Lutheran Gen Hospital (Residency)