Compared Efficacy and Tolerance of Two Vasopressors Used to Treat Preoperative Hypotension During Carotid Surgery

University Hospital, Clermont-Ferrand80 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Endovascular Carotid Surgery Preoperative Hypotension

Interventions

ephedrine and phenylephrineDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

CHU Clermont-Ferrand

Clermont-Ferrand, France

Outcomes

Primary Outcomes

Cerebral oxygen saturation (SctO2)

Time frame: at day 1

Secondary Outcomes

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

Data from ClinicalTrials.gov

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