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Completed

NCT Number: NCT01794273

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

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

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Key information

Conditions

Endovascular Carotid Surgery Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hypotension Nervous System Diseases Preoperative Hypotension Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ephedrine and phenylephrine

Drug

Primary outcomes

  1. Cerebral oxygen saturation (SctO2)

    Time frame: at day 1

Secondary outcomes

  1. Incidence of post-treatment hypotension

    Time frame: At day 1

  2. Incidence of post-treatment bradycardia

    Time frame: at day 1

  3. Postoperative morbidity: cardiovascular, cerebral, renal, surgical

    Time frame: at day 1

  4. Postoperative recovery

    Time frame: at day 1

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

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

Acronym: VP-hTA-XCar

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 18, 2013
Registry last updated
Sep 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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