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Compared Efficacy and Tolerance of Two Vasopressors Used to Treat Preoperative Hypotension During Carotid Surgery (VP-hTA-XCar)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2013 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01794273
First received: February 15, 2013
Last updated: NA
Last verified: February 2013
History: No changes posted
February 15, 2013
February 15, 2013
July 2012
July 2013   (Final data collection date for primary outcome measure)
Cerebral oxygen saturation (SctO2) [ Time Frame: at day 1 ]
Same as current
No Changes Posted
  • Incidence of post-treatment hypotension [ Time Frame: At day 1 ]
  • Incidence of post-treatment bradycardia [ Time Frame: at day 1 ]
  • Postoperative morbidity: cardiovascular, cerebral, renal, surgical [ Time Frame: at day 1 ]
  • Postoperative recovery [ Time Frame: at day 1 ]
Same as current
Not Provided
Not Provided
 
Compared Efficacy and Tolerance of Two Vasopressors Used to Treat Preoperative Hypotension During Carotid Surgery
Compared Efficacy and Tolerance of Two Vasopressors Used to Treat Preoperative Hypotension During Carotid Surgery. Prospective Randomised Controlled and Single Centre Trial
The effects on brain perfusion of the two currently vasopressors used to treat accidental hypotension occurring during carotid surgery (i.e. ephedrine and phenylephrine) is not known, but a disadvantage to use phenylephrine is suspected, due to its mechanism of action and according to published reports
This is a randomised trial comparing ephedrine and phenylephrine as used for accidental hypotension occurring during carotid surgery, on cerebral perfusion, assessed by near-infrared spectroscopy (NIRS).
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
  • Endovascular Carotid Surgery;
  • Preoperative Hypotension;
Drug: ephedrine and phenylephrine
  • Experimental: ephedrine
    This is a randomised trial comparing ephedrine and phenylephrine as used for accidental hypotension occurring during carotid surgery, on cerebral perfusion, assessed by near-infrared spectroscopy (NIRS).
    Intervention: Drug: ephedrine and phenylephrine
  • Experimental: phenylephrine
    This is a randomised trial comparing ephedrine and phenylephrine as used for accidental hypotension occurring during carotid surgery, on cerebral perfusion, assessed by near-infrared spectroscopy (NIRS).
    Intervention: Drug: ephedrine and phenylephrine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
120
December 2013
July 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age over 18 ASA score I-III Planned carotid endarteriectomy under general anaesthesia Hypotension defined as SAP < 90 mm Hg during general anaesthesia Informed consent to the trial Protected by the French health welfare

Exclusion Criteria:

  • Emergency surgery Cardiac arrythmia Pregnancy or breastfeeding Allergy to the tested treatment Allergy to hydroxyethylstarch Allergy to the glue of the NIRS's electrodes Current medication: MAOI, intranasal vasopressors
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01794273
CHU-0147
2012-001827-11
Not Provided
Not Provided
Not Provided
University Hospital, Clermont-Ferrand
University Hospital, Clermont-Ferrand
Not Provided
Principal Investigator: Charlotte BAUD University Hospital, Clermont-Ferrand
University Hospital, Clermont-Ferrand
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP