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

Information source: University Hospital, Clermont-Ferrand
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Endovascular Carotid Surgery;; Preoperative Hypotension;

Intervention: ephedrine and phenylephrine (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University Hospital, Clermont-Ferrand

Official(s) and/or principal investigator(s):
Charlotte BAUD, Principal Investigator, Affiliation: University Hospital, Clermont-Ferrand

Overall contact:
Patrick LACARIN, Phone: 04.73.75.11.95, Email: placarin@chu-clermontferrand.fr

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Primary outcome: Cerebral oxygen saturation (SctO2)

Secondary outcome:

Incidence of post-treatment hypotension

Incidence of post-treatment bradycardia

Postoperative morbidity: cardiovascular, cerebral, renal, surgical

Postoperative recovery

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).

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 and Contacts

Patrick LACARIN, Phone: 04.73.75.11.95, Email: placarin@chu-clermontferrand.fr

CHU Clermont-Ferrand, Clermont-Ferrand 63003, France; Recruiting
Patrick LACARIN, Phone: 04 73 75 11 95, Email: placarin@chu-clermontferrand.fr
Additional Information

Starting date: July 2012
Last updated: February 15, 2013

Page last updated: August 23, 2015

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