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

Study Overview
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Brief Summary
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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

Detailed Description
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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).

Official Title
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Compared Efficacy and Tolerance of Two Vasopressors Used to Treat Preoperative Hypotension During Carotid Surgery. Prospective Randomised Controlled and Single Centre Trial

Conditions
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Endovascular Carotid Surgery, Preoperative Hypotension

Intervention / Treatment
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* Drug: ephedrine and phenylephrine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ephedrine<br>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). | Drug: ephedrine and phenylephrine<br> <br> |
| Experimental: phenylephrine<br>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). | Drug: ephedrine and phenylephrine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral oxygen saturation (SctO2) |  | at day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of post-treatment hypotension |  | At day 1 | 
| Incidence of post-treatment bradycardia |  | at day 1 | 
| Postoperative morbidity: cardiovascular, cerebral, renal, surgical |  | at day 1 | 
| Postoperative recovery |  | at day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ephedrine, Phenylephrine, Vasopressor, Carotid surgery, Hypotension, Haemodynamics, Brain ischemia, Tissue perfusion, Stroke, anaesthesia