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Compared Efficacy and Tolerance of Two Vasopressors Used to Treat Preoperative Hypotension During Carotid Surgery (VP-hTA-XCar)

Primary Purpose

Endovascular Carotid Surgery, Preoperative Hypotension

Status

Completed

Phase

Phase 4

Locations

France

Study Type

Interventional

Intervention

ephedrine and phenylephrine

About this trial

This is an interventional other trial for Endovascular Carotid Surgery focused on measuring Ephedrine, Phenylephrine, Vasopressor, Carotid surgery, Hypotension, Haemodynamics, Brain ischemia, Tissue perfusion, Stroke, anaesthesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

CHU Clermont-Ferrand

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

ephedrine

phenylephrine

Arm 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).

Outcomes

Primary Outcome Measures

Cerebral oxygen saturation (SctO2)

Secondary Outcome Measures

Incidence of post-treatment hypotension

Incidence of post-treatment bradycardia

Postoperative morbidity: cardiovascular, cerebral, renal, surgical

Postoperative recovery

Full Information

NCT ID

NCT01794273

First Posted

February 15, 2013

Last Updated

September 20, 2018

Sponsor

University Hospital, Clermont-Ferrand

1. Study Identification

Unique Protocol Identification Number

NCT01794273

Brief Title

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

Acronym

VP-hTA-XCar

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 Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Completed

Study Start Date

July 2012 (Actual)

Primary Completion Date

July 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Clermont-Ferrand

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Endovascular Carotid Surgery, Preoperative Hypotension

Keywords

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

7. Study Design

Primary Purpose

Other

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ephedrine

Arm Type

Experimental

Arm Description

Arm Title

phenylephrine

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

ephedrine and phenylephrine

Primary Outcome Measure Information:

Title

Cerebral oxygen saturation (SctO2)

Time Frame

at day 1

Secondary Outcome Measure Information:

Title

Incidence of post-treatment hypotension

Time Frame

At day 1

Title

Incidence of post-treatment bradycardia

Time Frame

at day 1

Title

Postoperative morbidity: cardiovascular, cerebral, renal, surgical

Time Frame

at day 1

Title

Postoperative recovery

Time Frame

at day 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Charlotte BAUD

Organizational Affiliation

University Hospital, Clermont-Ferrand

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU Clermont-Ferrand

City

Clermont-Ferrand

ZIP/Postal Code

63003

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

28378467

Citation

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.

Results Reference

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

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