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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2006 by Lawson Health Research Institute.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00294606
First received: February 17, 2006
Last updated: NA
Last verified: February 2006
History: No changes posted
  Purpose

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.


Condition Intervention
Vasopressor Agents
Endarterectomy, Carotid
Echocardiography, Transesophageal
 Drug: Comparison of Effects of Phenylephrine and Norepinephrine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Official Title: Comparison of the Effects of Phenylephrine and Norepinephrine on Cardiac Function During Carotid Cross-Clamping During Carotid Endarterectomy Under General Anesthesia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Myocardial ischemia measures by transesophageal echocardiography and ST segment analyses

Secondary Outcome Measures:
  • Myocardial ischemia measures by cardiac troponin I

Estimated Enrollment: 86
Study Start Date: February 2006
Estimated Study Completion Date: February 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00294606

Contacts
Contact: Rosemary A Craen, MD, FRCPC (519) 663-3022 rosemary.craen@lhsc.on.ca
Contact: Hélène G Pellerin, MD, FRCPC (519) 663-3022 hpelleri@uwo.ca

Locations
Canada, Ontario
University Hospital, LHSC Recruiting
London, Ontario, Canada, N6A 5A5
Contact: Rosemary A Craen, MD, FRCPC     (519) 663-3022     Rosemary.Craen@lhsc.on.ca    
Principal Investigator: Rosemary A Craen, MD, FRCPC            
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Rosemary A Craen, MD, FRCPC Associate Professor University of Western Ontario
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00294606     History of Changes
Other Study ID Numbers: R-05-941
Study First Received: February 17, 2006
Last Updated: February 17, 2006
Health Authority: Canada: Health Canada

Keywords provided by Lawson Health Research Institute:
vasopressor agents
carotid endarterectomy
cardiac function
transesophageal echocardiography
wall motion abnormalities

Additional relevant MeSH terms:
Norepinephrine
Phenylephrine
Oxymetazoline
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
 Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-1 Receptor Agonists
Cardiotonic Agents
Mydriatics
Nasal Decongestants
Respiratory System Agents
Protective Agents

ClinicalTrials.gov processed this record on May 16, 2013