Comparison of the Effects of Phenylephrine and Norepinephrine on Cardiac Function During Carotid Artery Surgery

February 17, 2006 updated by: Lawson Health Research Institute

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • Recruiting
        • University Hospital, LHSC
        • Contact:
        • Principal Investigator:
          • Rosemary A Craen, MD, FRCPC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Elective carotid endarterectomy under general anesthesia
  • > 18 years old
  • Written informed consent

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Myocardial ischemia measures by transesophageal echocardiography and ST segment analyses

Secondary Outcome Measures

Outcome Measure
Myocardial ischemia measures by cardiac troponin I

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Investigators

  • Principal Investigator: Rosemary A Craen, MD, FRCPC, Associate Professor University of Western Ontario

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Study Completion

February 1, 2006

Study Registration Dates

First Submitted

February 17, 2006

First Submitted That Met QC Criteria

February 17, 2006

First Posted (Estimate)

February 22, 2006

Study Record Updates

Last Update Posted (Estimate)

February 22, 2006

Last Update Submitted That Met QC Criteria

February 17, 2006

Last Verified

February 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-05-941

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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