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

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

Full Title of Study: “Compared Efficacy and Tolerance of Two Vasopressors Used to Treat Preoperative Hypotension During Carotid Surgery. Prospective Randomised Controlled and Single Centre Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: July 2013

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

  • Drug: ephedrine and phenylephrine

Arms, Groups and Cohorts

  • Experimental: ephedrine
    • 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).
  • Experimental: phenylephrine
    • 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).

Clinical Trial Outcome Measures

Primary Measures

  • Cerebral oxygen saturation (SctO2)
    • Time Frame: at day 1

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Clermont-Ferrand
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Charlotte BAUD, Principal Investigator, University Hospital, Clermont-Ferrand

References

Aliane J, Duale C, Guesmi N, Baud C, Rosset E, Pereira B, Bouvier D, Schoeffler P. Compared effects on cerebral oxygenation of ephedrine vs phenylephrine to treat hypotension during carotid endarterectomy. Clin Exp Pharmacol Physiol. 2017 Jul;44(7):739-748. doi: 10.1111/1440-1681.12759.

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