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

This study is currently recruiting participants.

Verified February 2013 by University Hospital, Clermont-Ferrand

Sponsor:

Information provided by (Responsible Party):

University Hospital, Clermont-Ferrand

ClinicalTrials.gov Identifier:

NCT01794273

First received: February 15, 2013

Last updated: NA

Last verified: February 2013

History: No changes posted

Tracking Information

First Received Date ^ICMJE

February 15, 2013

Last Updated Date

February 15, 2013

Start Date ^ICMJE

July 2012

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Cerebral oxygen saturation (SctO2) [ Time Frame: at day 1 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Incidence of post-treatment hypotension [ Time Frame: At day 1 ] [ Designated as safety issue: Yes ]
Incidence of post-treatment bradycardia [ Time Frame: at day 1 ] [ Designated as safety issue: Yes ]
Postoperative morbidity: cardiovascular, cerebral, renal, surgical [ Time Frame: at day 1 ] [ Designated as safety issue: Yes ]
Postoperative recovery [ Time Frame: at day 1 ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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).

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Endovascular Carotid Surgery;
Preoperative Hypotension;

Intervention ^ICMJE

Drug: ephedrine and phenylephrine

Study Arm (s)

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).

Intervention: Drug: ephedrine and phenylephrine
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).

Intervention: Drug: ephedrine and phenylephrine

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

120

Estimated Completion Date

December 2013

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Patrick LACARIN

04.73.75.11.95

placarin@chu-clermontferrand.fr

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01794273

Other Study ID Numbers ^ICMJE

CHU-0147, 2012-001827-11

Has Data Monitoring Committee

Not Provided

Responsible Party

University Hospital, Clermont-Ferrand

Study Sponsor ^ICMJE

University Hospital, Clermont-Ferrand

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Charlotte BAUD

University Hospital, Clermont-Ferrand

Information Provided By

University Hospital, Clermont-Ferrand

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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