The effect of blood pressure changes in blood pressure on cerebral perfusion during carotid surgery

• Conditions: Hypotension during carotid endarterectomy; MedDRA version: 14.1Level: PTClassification code 10062300Term: Procedural hypotensionSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; MedDRA version: 14.1Level: PTClassification code 10007692Term: Carotid endarterectomySystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

• Registration Number: EUCTR2011-003470-88-NL
• Lead Sponsor: niversity Medical Center Utrecht, The Netherlands

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-05
• Last Update Posted: 16 December 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

All patients undergoing CEA in the University Medical Centre Utrecht and having an appropriate temporal bone window for reliable perioperative TCD monitoring could be included. All patients must have given written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Patients will be excluded if they meet one of the following criteria:
1. Not having a temporal bone window appropriate for TCD measurement
2. Not willing to give informed consent.
3. If the effect on BP of the given agents is insufficient (if relative hypotension persists five minutes after administration).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To study the influence of two routinely used vasopressors (phenylephrine and ephedrine) on cerebral perfusion measured using NIRS, estimated by changes in cerebral oxygenation and middle cerebral artery blood velocity, in patient undergoing a carotid endarterectomy.<br>;Secondary Objective: To study the influence of two routinely used vasopressors (phenylephrine and ephedrine) on cerebral perfusion, estimated by changes in cerebral oxygenation and middle cerebral artery blood velocity measured using TCD, in patients with and without an adequate functioning cerebral autoregulation. ;Primary end point(s): Change in cerebral perfusion (rSO2) measured using Near InfraRed Spectroscopy (NIRS)<br>;Timepoint(s) of evaluation of this end point: During surgery

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Change in blood velocity in the middle cerebral artery (Vmca) measured using transcranial Doppler (TCD);Timepoint(s) of evaluation of this end point: during surgery