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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University Hospital, Clermont-Ferrand
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 ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
  • Incidence of post-treatment hypotension [ Time Frame: At day 1 ] [ Designated as safety issue: Yes ]
  • Incidence of post-treatment bradycardia [ Time Frame: at day 1 ] [ Designated as safety issue: Yes ]
  • Postoperative morbidity: cardiovascular, cerebral, renal, surgical [ Time Frame: at day 1 ] [ Designated as safety issue: Yes ]
  • Postoperative recovery [ Time Frame: at day 1 ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.
 
Recruiting
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
Both
18 Years and older
No
Contact: Patrick LACARIN 04.73.75.11.95 placarin@chu-clermontferrand.fr
France
 
NCT01794273
CHU-0147, 2012-001827-11
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