Vasopressor AgentsNCT00294606
Comparison of the Effects of Phenylephrine and Norepinephrine on Cardiac Function During Carotid Artery Surgery
A study testing Comparison of Effects of Phenylephrine and Norepinephrine in people with Vasopressor Agents and Endarterectomy, Carotid, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
This will be a prospective, randomized, double-blinded, cross-over clinical trial to compare the effects of phenylephrine or norepinephrine on cardiac function during carotid artery surgery in patients under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vasopressor Agents, Endarterectomy, Carotid, Echocardiography, Transesophageal
- What is being tested?
- Comparison of Effects of Phenylephrine and Norepinephrine
- How many people
- 86 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2006to Feb 2006
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective carotid endarterectomy under general anesthesia
- > 18 years old
- Written informed consent
Who cannot join
- Contraindication to general anesthesia
- Contraindication to transesophageal anesthesia
- esophageal disease
- esophageal stricture
- history of esophageal or gastric bleeding
- esophageal anatomic abnormality
- past esophageal or gastric surgery
- severe dysphagia
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University Hospital, LHSC
London, Ontario, N6A 5A5
Rosemary A Craen, MD, FRCPC, (519) 663-3022, Rosemary.Craen@lhsc.on.ca
Rosemary A Craen, MD, FRCPC
About this study
Official title: Comparison of the Effects of Phenylephrine and Norepinephrine on Cardiac Function During Carotid Cross-Clamping During Carotid Endarterectomy Under General Anesthesia
This will be a prospective, randomized, double-blinded, cross-over clinical trial to compare the effects of phenylephrine or norepinephrine on cardiac function during carotid artery surgery in patients under general anesthesia. The effect of the vasopressor on cardiac function will be measured using electrocardiography, transesophageal echocardiography and cardiac troponin I intraoperatively and postoperatively. We will use a cross-over pattern since both drugs exhibit rapid onset and short duration of action. We hypothesize that there will be less myocardial ischemia associated with the use of norepinephrine when compared with phenylephrine during carotid artery surgery.
- Being tested
- Comparison of Effects of Phenylephrine and Norepinephrine
- Keywords
- vasopressor agents, carotid endarterectomy, cardiac function, transesophageal echocardiography, wall motion abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of Effects of Phenylephrine and NorepinephrineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial ischemia measures by transesophageal echocardiography and ST segment analyses
Secondary outcomes (1)
Myocardial ischemia measures by cardiac troponin I
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2006 (estimated)
- Study startFeb 2006
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vasopressor AgentsStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Double blind
- Enrolment
- 86 participants
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Investigators
- Rosemary A Craen, MD, FRCPC, Principal investigator, Associate Professor University of Western Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00294606
- Sponsor's protocol ID
- R-05-941
- Status last verified
- Feb 2006
- First submitted
- 17 Feb 2006
- Last updated
- 22 Feb 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Phenylephrine and Norepinephrine on Cardiac Function During Carotid Cross-Clamping During Carotid Endarterectomy Under General Anesthesia
- ClinicalTrials.gov ID
- NCT00294606
- Acronym / sponsor ID
- R-05-941
- Keywords
- vasopressor agents, carotid endarterectomy, cardiac function, transesophageal echocardiography, wall motion abnormalities
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Feb 2006
- Study completion
- Feb 2006
- First posted
- 22 Feb 2006 (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.
This will be a prospective, randomized, double-blinded, cross-over clinical trial to compare the effects of phenylephrine or norepinephrine on cardiac function during carotid artery surgery in patients under general anesthesia. The effect of the vasopressor on cardiac function will be measured using electrocardiography, transesophageal echocardiography and cardiac troponin I intraoperatively and postoperatively. We will use a cross-over pattern since both drugs exhibit rapid onset and short duration of action. We hypothesize that there will be less myocardial ischemia associated with the use of norepinephrine when compared with phenylephrine during carotid artery surgery.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elective carotid endarterectomy under general anesthesia
- > 18 years old
- Written informed consent
Key exclusion criteria (8 listed)
- Contraindication to general anesthesia
- Contraindication to transesophageal anesthesia
- esophageal disease
- esophageal stricture
- history of esophageal or gastric bleeding
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 |
|---|---|---|
| Comparison of Effects of Phenylephrine and Norepinephrine | Drug | – |
Primary outcome
Myocardial ischemia measures by transesophageal echocardiography and ST segment analyses
1 secondary outcome
Myocardial ischemia measures by cardiac troponin I
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2006.
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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.
Rosemary A Craen, MD, FRCPC principal investigator
Associate Professor University of Western Ontario
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comparison of Effects of Phenylephrine and Norepinephrine in people with Vasopressor Agents and Endarterectomy, Carotid, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 22 Feb 2006. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rosemary A Craen, MD, FRCPC ((519) 663-3022, rosemary.craen@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial ischemia measures by transesophageal echocardiography and ST segment analyses. It is what the study was designed to measure, not a finding.
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 22 Feb 2006.