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

Endovascular Carotid Surgery Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01794273
• Other study ID #: CHU-0147
• Secondary ID: 2012-001827-11
• Status: Completed
• Phase: Phase 4
• Start date: July 2012
• Est. completion date: December 2013

Study information

• Verified date: September 2018
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endovascular Carotid Surgery
• Hypotension
• Preoperative Hypotension

Intervention

Drug:
• ephedrine and phenylephrine

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

References & Publications (1)

Aliane J, Dualé 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral oxygen saturation (SctO2)		at day 1
Secondary	Incidence of post-treatment hypotension		At day 1
Secondary	Incidence of post-treatment bradycardia		at day 1
Secondary	Postoperative morbidity: cardiovascular, cerebral, renal, surgical		at day 1
Secondary	Postoperative recovery		at day 1