NCT00294606

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2006

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 22, 2006

Completed
Last Updated

February 22, 2006

Status Verified

February 1, 2006

First QC Date

February 17, 2006

Last Update Submit

February 17, 2006

Conditions

Vasopressor AgentsEndarterectomy, CarotidEchocardiography, Transesophageal

Keywords

vasopressor agentscarotid endarterectomycardiac functiontransesophageal echocardiographywall motion abnormalities

Outcome Measures

Primary Outcomes (1)

  • Myocardial ischemia measures by transesophageal echocardiography and ST segment analyses

Secondary Outcomes (1)

  • Myocardial ischemia measures by cardiac troponin I

Interventions

Comparison of Effects of Phenylephrine and NorepinephrineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, LHSC

London, Ontario, N6A 5A5, Canada

RECRUITING

MeSH Terms

Interventions

Norepinephrine

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Rosemary A Craen, MD, FRCPC

    Associate Professor University of Western Ontario

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rosemary A Craen, MD, FRCPC

CONTACT

(519) 663-3022rosemary.craen@lhsc.on.ca

Hélène G Pellerin, MD, FRCPC

CONTACT

(519) 663-3022hpelleri@uwo.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 17, 2006

First Posted

February 22, 2006

Study Start

February 1, 2006

Study Completion

February 1, 2006

Last Updated

February 22, 2006

Record last verified: 2006-02

Locations

CA(1)