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

Echocardiography, Transesophageal Clinical Trial

Official title:

Comparison of the Effects of Phenylephrine and Norepinephrine on Cardiac Function During Carotid Cross-Clamping During Carotid Endarterectomy Under General Anesthesia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00294606
• Other study ID #: R-05-941
• Status: Recruiting
• Phase: N/A
• First received: February 17, 2006
• Last updated: February 17, 2006
• Start date: February 2006
• Est. completion date: February 2006

Study information

• Verified date: February 2006
• Source: Lawson Health Research Institute
• Contact: Rosemary A Craen, MD, FRCPC
• Phone: (519) 663-3022
• Email: rosemary.craen[@]lhsc.on.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Echocardiography, Transesophageal
• Endarterectomy, Carotid
• Vasopressor Agents

Intervention

Drug:
• Comparison of Effects of Phenylephrine and Norepinephrine

Locations

Country	Name	City	State
Canada	University Hospital, LHSC	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial ischemia measures by transesophageal echocardiography and ST segment analyses
Secondary	Myocardial ischemia measures by cardiac troponin I