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Fentanyl for Low Blood Pressure (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

Fentanyl Trial 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.

Fentanyl Trial 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 60 minutes following dose administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Development of hypotension

Side effects data

From 2009 Phase 4 trial • 237 Patients • NCT01795898

100%

Aneurysm ruptured

54%

Dizziness

39%

Nausea

26%

Vomiting

16%

Somnolence

Pruritus

Insomnia

Headache

Weakness

Palpitation

Rashes

Chest pain

Cold clammy perspiration

Flushing

Muscle trembling

Constipation

100%

80%

60%

40%

20%

Study treatment Arm

Fentanyl

Fentanyl 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Loyola UniversityLead Sponsor

156 Previous Clinical Trials

30,829 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)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which medical conditions are alleviated by Fentanyl?

"While commonly used to treat diarrhea, fentanyl can also be employed during general anesthesia, for certain types of surgery, and as part of urine alkalinization therapy."

Answered by AI

How many individuals are taking part in this experiment at most?

"That is correct. The clinical trial, which was originally posted on 2/19/2018 and updated on 6/4/2019, is seeking 105 patients from 1 site."

Answered by AI

Is patient recruitment for this research still open?

"Yes, this trial is still looking for patients. The listing on clinicaltrials.gov shows that the study was first posted on February 19th, 2018 and updated as recently as June 4th, 2019."

Answered by AI

What is the research history of Fentanyl?

"Currently, there are 155 Fentanyl clinical trials underway with 41 of them in Phase 3. Calgary, Alberta has a significant number of these studies, but there are 465 total research sites for this medication across the world."

Answered by AI

Recent research and studies

Anesthesia & AnalgesiaJournal

Predictors of Hypotension After Induction of General Anesthesia

Reich, David L., Sabera Hossain, Marina Krol, Bernard Baez, Puja Patel, Ariel Bernstein, and Carol A. Bodian. 2005. “Predictors of Hypotension After Induction of General Anesthesia”. Anesthesia & Analgesia. Ovid Technologies (Wolters Kluwer Health). doi:10.1213/01.ane.0000175214.38450.91.

AnesthesiologyJournal

Incidence of Intraoperative Hypotension as a Function of the Chosen Definition

Bijker, Jilles B., Wilton A. van Klei, Teus H. Kappen, Leo van Wolfswinkel, Karel G. M. Moons, and Cor J. Kalkman. 2007. “Incidence of Intraoperative Hypotension as a Function of the Chosen Definition”. Anesthesiology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/01.anes.0000270724.40897.8e.

AnesthesiologyJournal

Intraoperative Hypotension and 1-year Mortality After Noncardiac Surgery

Bijker, Jilles B., Wilton A. van Klei, Yvonne Vergouwe, Douglas J. Eleveld, Leo van Wolfswinkel, Karel G. M. Moons, and Cor J. Kalkman. 2009. “Intraoperative Hypotension and 1-year Mortality After Noncardiac Surgery”. Anesthesiology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/aln.0b013e3181c14930.

AnesthesiologyJournal