The Effect of Blood Pressure on Cerebral Perfusion During Vascular Surgery
Primary Purpose
Anesthesia, Peripheral Arterial Diseases
Status
Withdrawn
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
MAP maintained at 80 mmHg
MAP maintained at 60 mmHg
Sponsored by
About this trial
This is an interventional supportive care trial for Anesthesia focused on measuring Cerebrovascular Circulation, Anesthesia, Blood pressure, Peripheral Arterial Diseases
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing one of the following vascular surgical interventions in general anesthesia: Infra-inguinal bypass, femoro-femoral cross-over bypass or iliofemoral bypass surgery.
- Age > 18 years. Informed consent
Exclusion Criteria:
- Use of monoamine oxidase inhibitors
- Allergy to phenylephrine
- Patients that cannot cooperate during examination
- Dementia defined as Mini-Mental State Examination < 24
- Anesthesia within the last 30 days
- Alcohol consumption at or above 420 grams per week
- Lack of fluency in written and spoken Danish
- Severe hearing and vision impairment
- Neurological disease
Sites / Locations
- Rigshospitalet, Anæstesi og Operationsklinikken 2043
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MAP maintained at 80 mmHg
MAP maintained at 60 mmHg
Arm Description
During anesthesia MAP is maintained at 80 - 90 mmHg MAP using continuous infusion of phenylephrine.
During anesthesia MAP is maintained at minimum of 60 mmHg using continuous infusion of phenylephrine.
Outcomes
Primary Outcome Measures
Middle cerebral artery blood velocity
Middle cerebral artery blood velocity measured in [cm/s] assessed by transcranial Doppler. Changes in middle cerebral artery blood velocity reflects changes in cerebral blood flow.
Secondary Outcome Measures
Change in serum S100B as compared between subjects in the control- and intervention groups
Serum concentrations of S100B, a marker of neuronal injury
Change in serum neuron-specific enolase as compared between subjects in the control- and intervention groups
Serum concentrations of neuron-specific enolase, a marker of neuronal injury
Regional cerebral oxygenation as compared between subjects in the control- and intervention groups
Frontal lobe oxygenation measured as the percentage of oxyhemoglobin of total hemoglobin [%] evaluated by near-infrared spectroscopy
Cardiac output as compared between subjects in the control- and intervention groups
Cardiac output measured in [l/min] evaluated by pulse contour analysis of the arterial blood pressure curve
Stroke volume as compared between subjects in the control- and intervention groups
Stroke volume measured in [ml/min] evaluated by pulse contour analysis of the arterial blood pressure curve
Full Information
NCT ID
NCT02531139
First Posted
August 14, 2015
Last Updated
September 26, 2017
Sponsor
Rigshospitalet, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT02531139
Brief Title
The Effect of Blood Pressure on Cerebral Perfusion During Vascular Surgery
Official Title
The Effect of Blood Pressure on Cerebral Perfusion and Oxygenation During Vascular Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Study was not feasible.
Study Start Date
March 1, 2017 (Anticipated)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
November 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Anesthesia reduces blood pressure and cerebral blood flow is normally considered to be maintained despite marked changes in blood pressure. Vascular surgical patients are often elderly, have high blood pressure and atherosclerosis and in these patients cerebral blood flow may decrease if blood pressure is reduced during anesthesia. The purpose of this study is to assess the effect of blood pressure for preservation of cerebral blood flow during anesthesia in vascular surgery. The hypothesis is that in vascular surgical patients, during anesthesia, cerebral blood flow is higher with blood pressure maintained at a higher level than that used in normal clinical practice.
Detailed Description
Background: Induction of anesthesia reduces mean arterial pressure (MAP) and cerebral blood flow is normally considered to be maintained by cerebral autoregulation despite changes in MAP between 60 - 150 mmHg and standard of care during anesthesia is to maintain MAP above 60 mmHg. Vascular surgical patients are often elderly with hypertension and atherosclerotic manifestations that may impair cerebral autoregulation of importance for anesthesia-induced reduction in blood pressure.
Objective: To assess the effect of MAP for preservation of cerebral blood flow and oxygenation during vascular surgery.
Hypothesis: The primary hypothesis is that during general anesthesia in vascular surgical patients, cerebral blood flow velocity and oxygenation is higher with MAP maintained at 80-90 mmHg, compared with a MAP maintained at a minimum of 60 mmHg.
MAP is controlled in both groups using continuous infusion of phenylephrine. Phenylephrine is used as a tool in order to assess the effect of MAP on the cerebral circulation. In both groups, central blood volume is optimized by infusion of lactated Ringer´s solution using a goal directed fluid therapy following induction of anaesthesia and before commencement of phenylephrine infusion.
Trial size: The investigators will include 40 participants (2 x 20) in order to detect or reject a 20% difference in middle cerebral artery velocity with a type I error risk of 5% and a type II error risk of 20% (power at 80%). Interim analysis will be conducted after inclusion of 20 patients (2 x 10). Excluded patients will be replaced.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Peripheral Arterial Diseases
Keywords
Cerebrovascular Circulation, Anesthesia, Blood pressure, Peripheral Arterial Diseases
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MAP maintained at 80 mmHg
Arm Type
Experimental
Arm Description
During anesthesia MAP is maintained at 80 - 90 mmHg MAP using continuous infusion of phenylephrine.
Arm Title
MAP maintained at 60 mmHg
Arm Type
Active Comparator
Arm Description
During anesthesia MAP is maintained at minimum of 60 mmHg using continuous infusion of phenylephrine.
Intervention Type
Other
Intervention Name(s)
MAP maintained at 80 mmHg
Intervention Description
Intervention group, MAP is maintained at 80 - 90 mmHg during anesthesia using continuous infusion of phenylephrine.
Intervention Type
Other
Intervention Name(s)
MAP maintained at 60 mmHg
Intervention Description
Control group, MAP is maintained at minimum of 60 mmHg during anesthesia using continuous infusion of phenylephrine.
Primary Outcome Measure Information:
Title
Middle cerebral artery blood velocity
Description
Middle cerebral artery blood velocity measured in [cm/s] assessed by transcranial Doppler. Changes in middle cerebral artery blood velocity reflects changes in cerebral blood flow.
Time Frame
During surgery
Secondary Outcome Measure Information:
Title
Change in serum S100B as compared between subjects in the control- and intervention groups
Description
Serum concentrations of S100B, a marker of neuronal injury
Time Frame
Blood is sampled 10 min prior to induction of anesthesia and at the end of surgery
Title
Change in serum neuron-specific enolase as compared between subjects in the control- and intervention groups
Description
Serum concentrations of neuron-specific enolase, a marker of neuronal injury
Time Frame
Blood is sampled 10 min prior to induction of anesthesia and at the end of surgery
Title
Regional cerebral oxygenation as compared between subjects in the control- and intervention groups
Description
Frontal lobe oxygenation measured as the percentage of oxyhemoglobin of total hemoglobin [%] evaluated by near-infrared spectroscopy
Time Frame
During surgery
Title
Cardiac output as compared between subjects in the control- and intervention groups
Description
Cardiac output measured in [l/min] evaluated by pulse contour analysis of the arterial blood pressure curve
Time Frame
During surgery
Title
Stroke volume as compared between subjects in the control- and intervention groups
Description
Stroke volume measured in [ml/min] evaluated by pulse contour analysis of the arterial blood pressure curve
Time Frame
During surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing one of the following vascular surgical interventions in general anesthesia: Infra-inguinal bypass, femoro-femoral cross-over bypass or iliofemoral bypass surgery.
Age > 18 years. Informed consent
Exclusion Criteria:
Use of monoamine oxidase inhibitors
Allergy to phenylephrine
Patients that cannot cooperate during examination
Dementia defined as Mini-Mental State Examination < 24
Anesthesia within the last 30 days
Alcohol consumption at or above 420 grams per week
Lack of fluency in written and spoken Danish
Severe hearing and vision impairment
Neurological disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niels D. Olesen, MD
Organizational Affiliation
Rigshospitalet, Anæstesi og Operationsklinikken 2043, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet, Anæstesi og Operationsklinikken 2043
City
Copenhagen Ø
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
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The Effect of Blood Pressure on Cerebral Perfusion During Vascular Surgery
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