Carotid StenosisPhase 4NCT02609087
Effect on Cerebral Oxygenation by Sevoflurane or Propofol Using Near-infrared Spectroscopy in Carotid Endarterectomy
A Phase 4 study testing Sevoflurane and Propofol in people with Carotid Stenosis, run by Chonnam National University Hospital at 1 site in South Korea.
Trial summary
The aim of this study is comparing the effect on cerebral oxygenation by sevoflurane-remifentanil or propofol-remifentanil anesthesia in patient undergoing carotid endarterectomy. Cerebral oxygenation is measured by near-infrared spectroscopy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Carotid Stenosis
- What is being tested?
- Sevoflurane and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2015to Dec 2016
- Phase
- Phase 4
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologist (ASA) physical status 1-3
- 18 ~ 70 years
- patient who agree with informed consent
Who cannot join
- ASA physical status > 4
- preoperative SpO2 < 97%
- patient who has other neurologic disease not related to carotid endarterectomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison the Effect on Cerebral Oxygenation by Sevoflurane-remifentanil or Propofol-remifentanil Anesthesia Using Near-infrared Spectroscopy in Patients Undergoing Carotid Endarterectomy)
The aim of this study is comparing the effect on cerebral oxygenation by sevoflurane-remifentanil or propofol-remifentanil anesthesia in patient undergoing carotid endarterectomy. Cerebral oxygenation is measured by near-infrared spectroscopy. Sevoflurane and propofol reduce the cerebral metabolic rate for oxygen in similar degree. Propofol decrease the cerebral blood flow by dose-dependent manner, however, sevoflurane increase the cerebral blood flow in the concentration of avobe 1 MAC. Both drugs are widely used in general anesthesia for neurosurgical procedure, and their effect on cerebral oxygenation are acceptable. There is little data about the effect of general anethetics on cerebral oxygenation in patients undergoing carotid endarterectomy, who have imparied cerebral circulation. Our hypothesis is sevoflurane will show better cerebral oxygenation than propofol in patient have impaired cerebral circulation.
Read the detailed description
This study is performed by monitoring the cerebral oxygenation using near-infrared spectroscopy from general anesthesia induction to 10 min after releasing the carotid artery clipping.
Study group: Sevoflurane - remifentanil anesthesia group (S) Propofol - remifentanil anesthesia group (R)
Monitoring: near-infrared spectroscopy (SOMA sensor) BIS, HR, arterial blood pressure, SpO2, body temperature
Patient seletion
- inclusion criteria
- American Society of Anesthesiologist (ASA) physical status 1-3
- 18 ~ 70 years
- patient who agree with informed concent
- exclusion criteria
- ASA physical status > 4
- preoperative SpO2 < 97%
- patient who has other neurologic disease not related to carotid endarterectomy
- Conditions
- Carotid Stenosis
- Being tested
- Sevoflurane, Propofol
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
PropofolDrug
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane | Experimental | adjust the end-tidal sevoflurane (sevofran inhaler, Hana pharmacy, Korea) concentration maintaining the 40 ~ 50 BIS (bispectral index) with 3 ng/ml of remifentanil using TCI (target controlled infusion) pump Receives: Drug: Sevoflurane |
| Propofol | Experimental | adjust propofol (FRESOFOL MCT INJ 2% (vial), Fresinus Kabi Korea) concentration maintaining the 40 ~ 50 BIS (bispectral index) with 3 ng/ml of remifentanil using TCI (target controlled infusion) pump Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
cerebral oxygenation measured by near-infrared spectroscopy
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2016
- Study completionDec 2016
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 Carotid StenosisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonnam National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seongtae Jeong, Chonnam National University Hospital
- Investigators
- Seongtae Jeong, Principal investigator, Chonnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02609087
- Sponsor's protocol ID
- CNUH-2015-159
- Status last verified
- Jan 2017
- First submitted
- 17 Nov 2015
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Park S, Yook K, Yoo KY, Choi JI, Bae HB, You Y, Jin B, Jeong S. Comparison of the effect of sevoflurane or propofol anesthesia on the regional cerebral oxygen saturation in patients undergoing carotid endarterectomy: a prospective, randomized controlled study. BMC Anesthesiol. 2019 Aug 17;19(1):157. doi: 10.1186/s12871-019-0820-9.
PubMed 31421685
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison the Effect on Cerebral Oxygenation by Sevoflurane-remifentanil or Propofol-remifentanil Anesthesia Using Near-infrared Spectroscopy in Patients Undergoing Carotid Endarterectomy)
- ClinicalTrials.gov ID
- NCT02609087
- Acronym / sponsor ID
- CNUH-2015-159
- Conditions
- Carotid Stenosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Chonnam National University HospitalUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 20 Nov 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.
The aim of this study is comparing the effect on cerebral oxygenation by sevoflurane-remifentanil or propofol-remifentanil anesthesia in patient undergoing carotid endarterectomy. Cerebral oxygenation is measured by near-infrared spectroscopy. Sevoflurane and propofol reduce the cerebral metabolic rate for oxygen in similar degree. Propofol decrease the cerebral blood flow by dose-dependent manner, however, sevoflurane increase the cerebral blood flow in the concentration of avobe 1 MAC. Both drugs are widely used in general anesthesia for neurosurgical procedure, and their effect on cerebral oxygenation are acceptable. There is little data about the effect of general anethetics on cerebral oxygenation in patients undergoing carotid endarterectomy, who have imparied cerebral circulation. Our hypothesis is sevoflurane will show better cerebral oxygenation than propofol in patient have impaired cerebral circulation.
Detailed description
This study is performed by monitoring the cerebral oxygenation using near-infrared spectroscopy from general anesthesia induction to 10 min after releasing the carotid artery clipping.
Study group: Sevoflurane - remifentanil anesthesia group (S) Propofol - remifentanil anesthesia group (R)
Monitoring: near-infrared spectroscopy (SOMA sensor) BIS, HR, arterial blood pressure, SpO2, body temperature
Patient seletion
- inclusion criteria
- American Society of Anesthesiologist (ASA) physical status 1-3
- 18 ~ 70 years
- patient who agree with informed concent
- exclusion criteria
- ASA physical status > 4
- preoperative SpO2 < 97%
- patient who has other neurologic disease not related to carotid endarterectomy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane | Experimental | Drug: Sevofluraneadjust the end-tidal sevoflurane (sevofran inhaler, Hana pharmacy, Korea) concentration maintaining the 40 ~ 50 BIS (bispectral index) with 3 ng/ml of remifentanil using TCI (target controlled infusion) pump |
| Propofol | Experimental | Drug: Propofoladjust propofol (FRESOFOL MCT INJ 2% (vial), Fresinus Kabi Korea) concentration maintaining the 40 ~ 50 BIS (bispectral index) with 3 ng/ml of remifentanil using TCI (target controlled infusion) pump |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologist (ASA) physical status 1-3
- 18 ~ 70 years
- patient who agree with informed consent
Key exclusion criteria (3 listed)
- ASA physical status > 4
- preoperative SpO2 < 97%
- patient who has other neurologic disease not related to carotid endarterectomy
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 |
|---|---|---|
| Sevoflurane | Drug | Sevoflurane |
| Propofol | Drug | Propofol |
Primary outcome
cerebral oxygenation measured by near-infrared spectroscopy
Time frame: one year
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 11 Jan 2017.
- Derived from this study: PubMed 31421685Park S, Yook K, Yoo KY, Choi JI, Bae HB, You Y, Jin B, Jeong S. Comparison of the effect of sevoflurane or propofol anesthesia on the regional cerebral oxygen saturation in patients undergoing carotid endarterectomy: a prospective, randomized controlled study. BMC Anesthesiol. 2019 Aug 17;19(1):157. doi: 10.1186/s12871-019-0820-9.
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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.
Seongtae Jeong principal investigator
Chonnam National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sevoflurane and Propofol in people with Carotid Stenosis, run by Chonnam National University Hospital at 1 site in South Korea.
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 3 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: finished, as of the sponsor's last update on 11 Jan 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 South Korea. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
cerebral oxygenation measured by near-infrared spectroscopy (time frame: one year). 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 NCT02609087, 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 11 Jan 2017.