Endovascular Carotid Surgery | Compared Efficacy and Tolerance of Two Vasopressors Used to Treat Preoperative Hypotension During Carotid Surgery
Endovascular Carotid Surgery research study
What is the primary objective of this study?
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
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Endovascular Carotid Surgery
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:ephedrine and phenylephrine
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
ephedrineThis 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).
phenylephrineThis 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).
Start Date: July 2012
Completed Date: December 2013
Phase: Phase 4
Primary Outcome: Cerebral oxygen saturation (SctO2)
Secondary Outcome: Incidence of post-treatment hypotension
Study sponsors, principal investigator, and references
Principal Investigator: Charlotte BAUD
Lead Sponsor: University Hospital, Clermont-Ferrand
Aliane J, Dualé C, Guesmi N, Baud C, Rosset E, Pereira B, Bouvier D, Schoeffler P. Compared effects on cerebral oxygenation of ephedrine vs phenylephrine to treat hypotension during carotid endarterectomy. Clin Exp Pharmacol Physiol. 2017 Jul;44(7):739-748. doi: 10.1111/1440-1681.12759.