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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

Preoperative Hypotension

Study Interventions

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

Study Arms

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).

Study Status

Completed

Start Date: July 2012

Completed Date: December 2013

Phase: Phase 4

Type: Interventional

Design:

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

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01794273

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.

Discuss Hypotension