Cerebrovascular CirculationSAMBANCT03816072
Quantification of Dynamic and Static Cerebral Autoregulation (CA) Under Anaesthesia
A study testing Phenylephrine infusion, Mechanical ventilation and Propofol in people with Cerebrovascular Circulation, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
Cerebral autoregulation (CA) is the mechanism by which the brain vasculature maintains constancy of cerebral blood flow (CBF). Reliable direct measurements of CBF at different blood pressure levels are difficult because they are invasive and time-consuming. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrovascular Circulation
- What is being tested?
- Phenylephrine infusion, Mechanical ventilation and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteNetherlands
- Study dates
- 7 Jan 2019to 23 Sep 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA-I or ASA-II, willing and able to give written informed consent, scheduled for elective, non-cardiothoracic surgery under general anaesthesia and age 18 years and above.
Who cannot join
- Patient related
- Unable/ unwilling to participate
- ASA-III or higher
- Age < 18 years
- History of: uncontrolled hypertension, diabetes, Parkinson's disease, uncontrolled cardiac arrhythmia, Pure autonomic failure (formerly called idiopathic orthostatic hypotension), Multiple system atrophy with autonomic failure (formerly called Shy-Drager syndrome), Addison's disease and hypopituitarism, pheochromocytoma, peripheral autonomic neuropathy (e.g., amyloid neuropathy, idiopathic autonomic neuropathy), known cardiomyopathy, extreme left ventricle hypertrophy or ejection fraction < 30%, proven or suspected allergy for any of the medication used during induction of anaesthesia, malignant hyperthermia.
- Unability to record transcranial Doppler ultrasound due to anatomical variance (~5% of population)
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- Contra-indications for intravenous or inhalational anaesthesia.
- Contra-indications for phenylephrine: severe hypertension, peripheral vascular illness, severe hyperthyroidism
- Simultaneous use of MAO-inhibitors, dopaminergic or vasoconstrictor ergot alkaloids (bromocriptine, cabergoline, pergolide, ergotamine, methylergometrine, methysergide), linezolid, tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors, digoxin, quinidine, oxytocin.
- Surgery related
- Day case surgery
- Laparoscopy with CO2 insufflation
- Extreme positioning during surgery (head-down/up tilt, lateral decubitus position, prone)
- Surgery < 60 minutes.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Amsterdam UMC, location AMC
Amsterdam, North Holland, 1105 AZ
About this study
Official title: Simultaneous Quantification of Dynamic and Static Cerebral Autoregulation (CA) at Different Steady-state Mean Blood Pressures Under Anaesthesia.
Cerebral autoregulation (CA) is the mechanism by which the brain vasculature maintains constancy of cerebral blood flow (CBF). Reliable direct measurements of CBF at different blood pressure levels are difficult because they are invasive and time-consuming. This type of measurement to quantify CA is generally referred to as static cerebral autoregulation (sCA). Alternatively, it is possible to measure CA indirectly from blood pressure oscillations. Dynamic cerebral autoregulation (dCA) measures how quickly the cerebral vessels react to a change in blood pressure to normalize CBF. Since the introduction of transcranial Doppler ultrasound (TCD), it has become possible to estimate CBF velocity relatively easy, which in turn correlates well with CBF changes. This method is widely used to quantify dCA. However, it is not clear how sCA correlates with dCA over a range of physiologic mean blood pressure (MBP). It is important to compare different methods of assessing CA, because impaired CA may result in increased risk of perioperative complications such as stroke. In this study, the investigators were interested in establishing the relationship between sCA and dCA during surgery under general anesthesia. The investigators aim to compare these methods during propofol and sevoflurane anesthesia.
- Conditions
- Cerebrovascular Circulation
- Being tested
- Phenylephrine infusion, Mechanical ventilation, Propofol, Sevoflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phenylephrine infusionDrug
Correction of anesthesia induced hypotension with phenylephrine to obtain sCA and dCA measurements at 60, 70, 80, 90 and 100 mmHg mean blood pressure. This is achieved by stepwise increases in phenylephrine infusion dose.
Mechanical ventilationOther
Patientes are mechanically ventilated at 6 bpm to obtain low frequency blood pressure oscillations (~0.1 Hz).
PropofolDrug
Propofol
SevofluraneDrug
Sevoflurane
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Active comparator | ASA-I/II patients undergoing elective, non-cardiothoracic surgery with intravenous anaesthesia (propofol). Receives: Drug: Phenylephrine infusion; Other: Mechanical ventilation; Drug: Propofol |
| Sevoflurane | Active comparator | ASA-I/II patients undergoing elective, non-cardiothoracic surgery with inhalational anaesthesia (sevoflurane). Receives: Drug: Phenylephrine infusion; Other: Mechanical ventilation; Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in dCA after several MBP-increasing steps.
Measured: Intraoperatively
Differences in dCA between sevoflurane and propofol at different steady-state MBP's.
Measured: Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start7 Jan 2019
- Primary completion23 Sep 2019
- Study completion23 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular CirculationStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients receive either propofol or sevoflurane to maintain anaesthesia. Both treatment groups receive the same phenylephrine and mechanical ventilation regimens.
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Niek Sperna Weiland, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Jeroen Hermanides, Dr., Principal investigator, Amsterdam UMC, location AMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03816072
- Sponsor's protocol ID
- METC 2018_230
- Acronym
- SAMBA
- Status last verified
- May 2021
- First submitted
- 21 Jan 2019
- Last updated
- 27 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van den Dool REC, Sperna Weiland NH, Schenk J, Kho E, Veelo DP, van der Ster BJP, Immink RV. Dynamic cerebral autoregulation during step-wise increases in blood pressure during anaesthesia: A nonrandomised interventional trial. Eur J Anaesthesiol. 2023 Jun 1;40(6):407-417. doi: 10.1097/EJA.0000000000001798. Epub 2023 Feb 6.
PubMed 36655712
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simultaneous Quantification of Dynamic and Static Cerebral Autoregulation (CA) at Different Steady-state Mean Blood Pressures Under Anaesthesia.
- ClinicalTrials.gov ID
- NCT03816072
- Acronym / sponsor ID
- SAMBA / METC 2018_230
- Conditions
- Cerebrovascular Circulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 23 Sep 2019 (actual)
- Study completion
- 23 Sep 2019 (actual)
- First posted
- 25 Jan 2019 (actual)
- 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.
Cerebral autoregulation (CA) is the mechanism by which the brain vasculature maintains constancy of cerebral blood flow (CBF). Reliable direct measurements of CBF at different blood pressure levels are difficult because they are invasive and time-consuming. This type of measurement to quantify CA is generally referred to as static cerebral autoregulation (sCA). Alternatively, it is possible to measure CA indirectly from blood pressure oscillations. Dynamic cerebral autoregulation (dCA) measures how quickly the cerebral vessels react to a change in blood pressure to normalize CBF. Since the introduction of transcranial Doppler ultrasound (TCD), it has become possible to estimate CBF velocity relatively easy, which in turn correlates well with CBF changes. This method is widely used to quantify dCA. However, it is not clear how sCA correlates with dCA over a range of physiologic mean blood pressure (MBP). It is important to compare different methods of assessing CA, because impaired CA may result in increased risk of perioperative complications such as stroke. In this study, the investigators were interested in establishing the relationship between sCA and dCA during surgery under general anesthesia. The investigators aim to compare these methods during propofol and sevoflurane anesthesia.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients receive either propofol or sevoflurane to maintain anaesthesia. Both treatment groups receive the same phenylephrine and mechanical ventilation regimens.
| Arm | Type | Receives |
|---|---|---|
| Propofol | Active comparator | Drug: Phenylephrine infusion, Other: Mechanical ventilation, Drug: PropofolASA-I/II patients undergoing elective, non-cardiothoracic surgery with intravenous anaesthesia (propofol). |
| Sevoflurane | Active comparator | Drug: Phenylephrine infusion, Other: Mechanical ventilation, Drug: SevofluraneASA-I/II patients undergoing elective, non-cardiothoracic surgery with inhalational anaesthesia (sevoflurane). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA-I or ASA-II, willing and able to give written informed consent, scheduled for elective, non-cardiothoracic surgery under general anaesthesia and age 18 years and above.
Key exclusion criteria (14 listed)
- Patient related
- Surgery related
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 |
|---|---|---|
| Phenylephrine infusionCorrection of anesthesia induced hypotension with phenylephrine to obtain sCA and dCA measurements at 60, 70, 80, 90 and 100 mmHg mean blood pressure. This is achieved by stepwise increases in phenylephrine infusion dose. | Drug | Propofol, Sevoflurane |
| Mechanical ventilationPatientes are mechanically ventilated at 6 bpm to obtain low frequency blood pressure oscillations (~0.1 Hz). | Other | Propofol, Sevoflurane |
| PropofolPropofol | Drug | Propofol |
| SevofluraneSevoflurane | Drug | Sevoflurane |
Primary outcome
Changes in dCA after several MBP-increasing steps.
Time frame: Intraoperatively
Differences in dCA between sevoflurane and propofol at different steady-state MBP's.
Time frame: Intraoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
- Derived from this study: PubMed 36655712van den Dool REC, Sperna Weiland NH, Schenk J, Kho E, Veelo DP, van der Ster BJP, Immink RV. Dynamic cerebral autoregulation during step-wise increases in blood pressure during anaesthesia: A nonrandomised interventional trial. Eur J Anaesthesiol. 2023 Jun 1;40(6):407-417. doi: 10.1097/EJA.0000000000001798. Epub 2023 Feb 6.
- Individual participant dataSharing planned: No
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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.
Jeroen Hermanides, Dr. principal investigator
Amsterdam UMC, location AMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phenylephrine infusion, Mechanical ventilation and Propofol in people with Cerebrovascular Circulation, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 1 inclusion and 14 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: finished, as of the sponsor's last update on 27 May 2021. 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 Netherlands. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in dCA after several MBP-increasing steps. (time frame: Intraoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03816072, which also lists 1 linked publication.
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 27 May 2021.