Intra-operative HypotensionNCT01451294
Effect of Blood Pressure on rSO2 in Carotid Endarterectomy (CEA)
A study testing Administration of phenylephrine and Administration of ephedrine in people with Intra-operative Hypotension and Carotid Stenosis, run by G.J. de Borst at 1 site in Netherlands.
Trial summary
Carotid endarterectomy (CEA) is the recommended treatment for symptomatic high degree stenosis of the internal carotid artery (ICA). ICA obstruction is often associated with an impaired cerebral autoregulation, implicating that cerebral perfusion pressure becomes dependent on systemic blood pressure. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intra-operative Hypotension, Carotid Stenosis
- What is being tested?
- Administration of phenylephrine and Administration of ephedrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2011to Mar 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Not having a temporal bone window appropriate for TCD measurement
- Not willing to give informed consent.
- If the effect on BP of the given agents is insufficient (if relative hypotension persists five minutes after administration).
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Medical Center Utrecht
Utrecht, Utrecht, 3584 CX
Gert Jan de Borst, MD, PhD, +31 8875556965, g.j.deborst-2@umcutrecht.nl
About this study
Official title: The Effect of Phenylephrine Versus Ephedrine on Cerebral Perfusion During Carotid Endarterectomy
Carotid endarterectomy (CEA) is the recommended treatment for symptomatic high degree stenosis of the internal carotid artery (ICA). ICA obstruction is often associated with an impaired cerebral autoregulation, implicating that cerebral perfusion pressure becomes dependent on systemic blood pressure. Therefore, to maintain cerebral perfusion pressure in this type of patients intraoperative hypotension needs to be avoided. Different short-acting agents such as phenylephrine, (a drug with vasoconstrictive properties), or ephedrine (a drug with vasoconstrictive properties combined with an increase in heart rate) can be used to correct intra-operative hypotension. In healthy subjects these agents affect the cerebral perfusion differently despite an identical effect on the systemic blood pressure. Cerebral perfusion decreases after phenylephrine administration while it is preserved after the use of ephedrine. The optimal agent for correcting hypotension in CEA patients, and thus in a situation of an impaired cerebral autoregulation, is unknown.
Therefore, the investigators propose to perform a prospective study observing the effect of phenylephrine and ephedrine on cerebral perfusion to make a recommendation regarding the use of either phenylephrine or ephedrine during CEA.
- Conditions
- Intra-operative Hypotension, Carotid Stenosis
- Being tested
- Administration of phenylephrine, Administration of ephedrine
- Keywords
- Cerebral autoregulation
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of phenylephrineDrug
Phenylephrine: 50-100µg
Administration of ephedrineDrug
Ephedrine: 5- 10 mg
| Study group | Role | What they receive |
|---|---|---|
| Ephedrine | Active comparator | Not described Receives: Drug: Administration of ephedrine |
| Phenylephrine | Active comparator | Not described Receives: Drug: Administration of phenylephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
cerebral perfusion (rSO2) measured using Near Infrared Spectroscopy
A continuous measurement during surgery will be performed. However for further analysis only a short time frame will be used.
Measured: (day 1) Monitoring will take place only on the day of operation. No further follow-up. Timeframe is 1 day.
Secondary outcomes (1)
Blood velocity (Vmca) measured using transcranial Doppler
A continuous measurement during surgery will be performed. However for further analysis only a short time frame will be used.
Measured: Within 18 months in consecutive patients undergoing carotid endarterectomy. Endpoints will only be assessed during actual surgery (approximately 90 minutes in total) no data will be assessed during follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2011 (estimated)
- Study startNov 2011
- Primary completionMar 2012 (estimated)
- Study completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Intra-operative HypotensionStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- G.J. de Borst
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, G.J. de Borst, UMC Utrecht
- Investigators
- Gert Jan de Borst, MD, PhD, Study director, UMC Utrecht, The NetherlandsClaire Pennekamp, MD, Principal investigator, UMC Utrecht, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01451294
- Sponsor's protocol ID
- 11-195
- Status last verified
- Oct 2011
- First submitted
- 22 Sep 2011
- Last updated
- 13 Oct 2011
- Results posted
- No
Publications
Nissen P, Brassard P, Jorgensen TB, Secher NH. Phenylephrine but not ephedrine reduces frontal lobe oxygenation following anesthesia-induced hypotension. Neurocrit Care. 2010 Feb;12(1):17-23. doi: 10.1007/s12028-009-9313-x.
PubMed 19957053Fassaert LMM, de Borst GJ, Pennekamp CWA, Specken-Welleweerd JC, Moll FL, van Klei WA, Immink RV. Effect of Phenylephrine and Ephedrine on Cerebral (Tissue) Oxygen Saturation During Carotid Endarterectomy (PEPPER): A Randomized Controlled Trial. Neurocrit Care. 2019 Dec;31(3):514-525. doi: 10.1007/s12028-019-00749-w.
PubMed 31190322Heusdens JF, Lof S, Pennekamp CW, Specken-Welleweerd JC, de Borst GJ, van Klei WA, van Wolfswinkel L, Immink RV. Validation of non-invasive arterial pressure monitoring during carotid endarterectomy. Br J Anaesth. 2016 Sep;117(3):316-23. doi: 10.1093/bja/aew268.
PubMed 27543526Pennekamp CW, Immink RV, Buhre WF, Moll FL, de Borst GJ. Phenylephrine versus ephedrine on cerebral perfusion during carotid endarterectomy (PEPPER): study protocol for a randomized controlled trial. Trials. 2013 Feb 14;14:43. doi: 10.1186/1745-6215-14-43.
PubMed 23410186
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Phenylephrine Versus Ephedrine on Cerebral Perfusion During Carotid Endarterectomy
- ClinicalTrials.gov ID
- NCT01451294
- Acronym / sponsor ID
- 11-195
- Conditions
- Intra-operative Hypotension, Carotid Stenosis
- Keywords
- Cerebral autoregulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- G.J. de BorstUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 13 Oct 2011 (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.
Carotid endarterectomy (CEA) is the recommended treatment for symptomatic high degree stenosis of the internal carotid artery (ICA). ICA obstruction is often associated with an impaired cerebral autoregulation, implicating that cerebral perfusion pressure becomes dependent on systemic blood pressure. Therefore, to maintain cerebral perfusion pressure in this type of patients intraoperative hypotension needs to be avoided. Different short-acting agents such as phenylephrine, (a drug with vasoconstrictive properties), or ephedrine (a drug with vasoconstrictive properties combined with an increase in heart rate) can be used to correct intra-operative hypotension. In healthy subjects these agents affect the cerebral perfusion differently despite an identical effect on the systemic blood pressure. Cerebral perfusion decreases after phenylephrine administration while it is preserved after the use of ephedrine. The optimal agent for correcting hypotension in CEA patients, and thus in a situation of an impaired cerebral autoregulation, is unknown.
Therefore, the investigators propose to perform a prospective study observing the effect of phenylephrine and ephedrine on cerebral perfusion to make a recommendation regarding the use of either phenylephrine or ephedrine during CEA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ephedrine | Active comparator | Drug: Administration of ephedrine |
| Phenylephrine | Active comparator | Drug: Administration of phenylephrine |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- Not having a temporal bone window appropriate for TCD measurement
- Not willing to give informed consent.
- If the effect on BP of the given agents is insufficient (if relative hypotension persists five minutes after administration).
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 |
|---|---|---|
| Administration of phenylephrinePhenylephrine: 50-100µg | Drug | Phenylephrine |
| Administration of ephedrineEphedrine: 5- 10 mg | Drug | Ephedrine |
Primary outcome
cerebral perfusion (rSO2) measured using Near Infrared Spectroscopy
Time frame: (day 1) Monitoring will take place only on the day of operation. No further follow-up. Timeframe is 1 day.
A continuous measurement during surgery will be performed. However for further analysis only a short time frame will be used.
1 secondary outcome
Blood velocity (Vmca) measured using transcranial Doppler
Time frame: Within 18 months in consecutive patients undergoing carotid endarterectomy. Endpoints will only be assessed during actual surgery (approximately 90 minutes in total) no data will be assessed during follow-up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2011.
- Background: PubMed 19957053Nissen P, Brassard P, Jorgensen TB, Secher NH. Phenylephrine but not ephedrine reduces frontal lobe oxygenation following anesthesia-induced hypotension. Neurocrit Care. 2010 Feb;12(1):17-23. doi: 10.1007/s12028-009-9313-x.
- Derived from this study: PubMed 31190322Fassaert LMM, de Borst GJ, Pennekamp CWA, Specken-Welleweerd JC, Moll FL, van Klei WA, Immink RV. Effect of Phenylephrine and Ephedrine on Cerebral (Tissue) Oxygen Saturation During Carotid Endarterectomy (PEPPER): A Randomized Controlled Trial. Neurocrit Care. 2019 Dec;31(3):514-525. doi: 10.1007/s12028-019-00749-w.
- Derived from this study: PubMed 27543526Heusdens JF, Lof S, Pennekamp CW, Specken-Welleweerd JC, de Borst GJ, van Klei WA, van Wolfswinkel L, Immink RV. Validation of non-invasive arterial pressure monitoring during carotid endarterectomy. Br J Anaesth. 2016 Sep;117(3):316-23. doi: 10.1093/bja/aew268.
- Derived from this study: PubMed 23410186Pennekamp CW, Immink RV, Buhre WF, Moll FL, de Borst GJ. Phenylephrine versus ephedrine on cerebral perfusion during carotid endarterectomy (PEPPER): study protocol for a randomized controlled trial. Trials. 2013 Feb 14;14:43. doi: 10.1186/1745-6215-14-43.
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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.
Gert Jan de Borst, MD, PhD study director
UMC Utrecht, The Netherlands
Claire Pennekamp, MD principal investigator
UMC Utrecht, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Administration of phenylephrine and Administration of ephedrine in people with Intra-operative Hypotension and Carotid Stenosis, run by G.J. de Borst 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 13 Oct 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gert Jan de Borst, MD, PhD (+31 8875556965, g.j.deborst-2@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cerebral perfusion (rSO2) measured using Near Infrared Spectroscopy (time frame: (day 1) Monitoring will take place only on the day of operation. No further follow-up. Timeframe is 1 day.). 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 NCT01451294, which also lists 4 linked publications.
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 13 Oct 2011.