HealthyNCT00225043
A Randomized, Double-Blind, Trial Comparing Epinephrine Versus Phenylephrine as a Vasoconstrictor in Regional Anesthesia for Upper Extremity Surgery
A study testing Epinephrine/phenylephrine in people with Healthy, run by New York Presbyterian Brooklyn Methodist Hospital at 1 site in United States.
Trial summary
The study involves research, the purpose of which is to compare three different drug mixtures (Epinephrine, Phenylephrine 25 µg, or Phenylephrine 50 µg). Specifically, how long each medicine lasts will be studied. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Epinephrine/phenylephrine
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Aug 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Shoulder surgery with regional anesthesia
Who cannot join
- Shoulder surgery with general anesthesia unhealthy
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Methodist Hospital
Brooklyn, New York, 11215
About this study
The study involves research, the purpose of which is to compare three different drug mixtures (Epinephrine, Phenylephrine 25 µg, or Phenylephrine 50 µg). Specifically, how long each medicine lasts will be studied.
- Conditions
- Healthy
- Being tested
- Epinephrine/phenylephrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epinephrine/phenylephrineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Presbyterian Brooklyn Methodist Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Joel Yarmush, MD, MPA, Principal investigator, New York Presbyterian Brooklyn Methodist Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00225043
- Sponsor's protocol ID
- 299
- Status last verified
- May 2008
- First submitted
- 21 Sep 2005
- Last updated
- 2 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Trial Comparing Epinephrine Versus Phenylephrine as a Vasoconstrictor in Regional Anesthesia for Upper Extremity Surgery
- ClinicalTrials.gov ID
- NCT00225043
- Acronym / sponsor ID
- 299
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- New York Presbyterian Brooklyn Methodist HospitalUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 23 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study involves research, the purpose of which is to compare three different drug mixtures (Epinephrine, Phenylephrine 25 µg, or Phenylephrine 50 µg). Specifically, how long each medicine lasts will be studied.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Shoulder surgery with regional anesthesia
Key exclusion criteria (1 listed)
- Shoulder surgery with general anesthesia unhealthy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epinephrine/phenylephrine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joel Yarmush, MD, MPA principal investigator
New York Presbyterian Brooklyn Methodist Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epinephrine/phenylephrine in people with Healthy, run by New York Presbyterian Brooklyn Methodist Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2008.