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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01794273
Acronym
VP-hTA-XCar
Enrollment
80
Registered
2013-02-18
Start date
2012-07-01
Completion date
2013-12-01
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endovascular Carotid Surgery, Preoperative Hypotension

Keywords

Ephedrine, Phenylephrine, Vasopressor, Carotid surgery, Hypotension, Haemodynamics, Brain ischemia, Tissue perfusion, Stroke, anaesthesia

Brief summary

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

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).

Interventions

DRUGephedrine and phenylephrine

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Cerebral oxygen saturation (SctO2)at day 1

Secondary

MeasureTime frame
Incidence of post-treatment hypotensionAt day 1
Incidence of post-treatment bradycardiaat day 1
Postoperative morbidity: cardiovascular, cerebral, renal, surgicalat day 1
Postoperative recoveryat day 1

Countries

France

Contacts

PRINCIPAL_INVESTIGATORCharlotte BAUD

University Hospital, Clermont-Ferrand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 11, 2026