AnesthesiaNCT02531139
The Effect of Blood Pressure on Cerebral Perfusion During Vascular Surgery
A study testing MAP maintained at 80 mmHg and MAP maintained at 60 mmHg in people with Anesthesia and Peripheral Arterial Diseases, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Anesthesia, Peripheral Arterial Diseases
- What is being tested?
- MAP maintained at 80 mmHg and MAP maintained at 60 mmHg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2017to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Lack of fluency in written and spoken Danish
- Severe hearing and vision impairment
- Neurological disease
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Rigshospitalet, Anæstesi og Operationsklinikken 2043
Copenhagen Ø, 2100
About this study
Official title: The Effect of Blood Pressure on Cerebral Perfusion and Oxygenation During Vascular Surgery
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.
Read the 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.
- Conditions
- Anesthesia, Peripheral Arterial Diseases
- Being tested
- MAP maintained at 80 mmHg, MAP maintained at 60 mmHg
- Keywords
- Cerebrovascular Circulation, Anesthesia, Blood pressure, Peripheral Arterial Diseases
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAP maintained at 80 mmHgOther
Intervention group, MAP is maintained at 80 - 90 mmHg during anesthesia using continuous infusion of phenylephrine.
MAP maintained at 60 mmHgOther
Control group, MAP is maintained at minimum of 60 mmHg during anesthesia using continuous infusion of phenylephrine.
| Study group | Role | What they receive |
|---|---|---|
| MAP maintained at 80 mmHg | Experimental | During anesthesia MAP is maintained at 80 - 90 mmHg MAP using continuous infusion of phenylephrine. Receives: Other: MAP maintained at 80 mmHg |
| MAP maintained at 60 mmHg | Active comparator | During anesthesia MAP is maintained at minimum of 60 mmHg using continuous infusion of phenylephrine. Receives: Other: MAP maintained at 60 mmHg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During surgery
Secondary outcomes (5)
Change in serum S100B as compared between subjects in the control- and intervention groups
Serum concentrations of S100B, a marker of neuronal injury
Measured: Blood is sampled 10 min prior to induction of anesthesia and at the end of surgery
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
Measured: Blood is sampled 10 min prior to induction of anesthesia and at the end of surgery
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
Measured: During surgery
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
Measured: During surgery
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
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2015 (estimated)
- Study start1 Mar 2017 (estimated)
- Primary completionNov 2017 (estimated)
- Study completionNov 2017 (estimated)
Why it stopped: Study was not feasible.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Niels Damkjær Olesen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Niels D. Olesen, MD, Principal investigator, Rigshospitalet, Anæstesi og Operationsklinikken 2043, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02531139
- Sponsor's protocol ID
- NDOlesen
- Status last verified
- Sep 2017
- First submitted
- 14 Aug 2015
- Last updated
- 28 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Blood Pressure on Cerebral Perfusion and Oxygenation During Vascular Surgery
- ClinicalTrials.gov ID
- NCT02531139
- Acronym / sponsor ID
- NDOlesen
- Conditions
- Anesthesia, Peripheral Arterial Diseases
- Keywords
- Cerebrovascular Circulation, Anesthesia, Blood pressure, Peripheral Arterial Diseases
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was not feasible.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Mar 2017 (estimated)
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 24 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MAP maintained at 80 mmHg | Experimental | Other: MAP maintained at 80 mmHgDuring anesthesia MAP is maintained at 80 - 90 mmHg MAP using continuous infusion of phenylephrine. |
| MAP maintained at 60 mmHg | Active comparator | Other: MAP maintained at 60 mmHgDuring anesthesia MAP is maintained at minimum of 60 mmHg using continuous infusion of phenylephrine. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MAP maintained at 80 mmHgIntervention group, MAP is maintained at 80 - 90 mmHg during anesthesia using continuous infusion of phenylephrine. | Other | MAP maintained at 80 mmHg |
| MAP maintained at 60 mmHgControl group, MAP is maintained at minimum of 60 mmHg during anesthesia using continuous infusion of phenylephrine. | Other | MAP maintained at 60 mmHg |
Primary outcome
Middle cerebral artery blood velocity
Time frame: During surgery
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.
5 secondary outcomes
Change in serum S100B as compared between subjects in the control- and intervention groups
Time frame: Blood is sampled 10 min prior to induction of anesthesia and at the end of surgery
Change in serum neuron-specific enolase as compared between subjects in the control- and intervention groups
Time frame: Blood is sampled 10 min prior to induction of anesthesia and at the end of surgery
Regional cerebral oxygenation as compared between subjects in the control- and intervention groups
Time frame: During surgery
Cardiac output as compared between subjects in the control- and intervention groups
Time frame: During surgery
Stroke volume as compared between subjects in the control- and intervention groups
Time frame: During surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niels D. Olesen, MD principal investigator
Rigshospitalet, Anæstesi og Operationsklinikken 2043, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MAP maintained at 80 mmHg and MAP maintained at 60 mmHg in people with Anesthesia and Peripheral Arterial Diseases, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Middle cerebral artery blood velocity (time frame: During surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2017.