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

Phase 4

Completed

• Conditions: Endovascular Carotid Surgery; Preoperative Hypotension
• Interventions: Drug: ephedrine and phenylephrine

• Registration Number: NCT01794273
• Lead Sponsor: University Hospital, Clermont-Ferrand

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 Timeline

• Study Start: 2012-07
• Study First Submitted: 2013-02-15
• Study First Submitted QC: 2013-02-15
• Study First Posted: 2013-02-18
• Primary Completion: 2013-07
• Study Completion: 2013-12
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-20
• Last Update Posted: 2018-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ephedrine	ephedrine and 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).
phenylephrine	ephedrine and 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).

Primary Outcome Measures

Name	Time	Method
Cerebral oxygen saturation (SctO2)	at day 1

Secondary Outcome Measures

Name	Time	Method
Postoperative recovery	at day 1
Incidence of post-treatment hypotension	At day 1
Incidence of post-treatment bradycardia	at day 1
Postoperative morbidity: cardiovascular, cerebral, renal, surgical	at day 1

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France