Unruptured Cerebral AneurysmNCT02700126
Impact of Genetic Polymorphism on Propofol Requirement and Recovery for Total Intravenous Anesthesia for Clipping of Unruptured Cerebral Aneurysm in Korean Population
An observational study of Unruptured Cerebral Aneurysm, run by Yonsei University at 1 site in South Korea.
Trial summary
In neurosurgical anesthesia, propofol based total intravenous anesthesia (TIVA) is frequently used due to brain relaxation and less effect on electrophysiologic monitoring. Response to propofol can vary between individuals and be associated with clinical factors including age and weight, and genetic polymorphism. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Unruptured Cerebral Aneurysm
- Type of treatment
- Injection or infusion
- How many people
- 118 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Mar 2016to 22 Feb 2017
- Phase
- Observational
- 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
Study population: Korean adult population undergoing propofol based total intravenous anesthesia for clipping of unruptured cerebral aneurysm.
Who may be able to join
- 1. Korean adult population undergoing propofol based TIVA for clipping of unruptured cerebral aneurysm
Who cannot join
- patients not able to read, or understand the consent form
- ethnicity, other than Korean population
- patients refusal
- patients not to perform total intravenous anesthesia
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
Seoul, Seoul, 03722
About this study
In neurosurgical anesthesia, propofol based total intravenous anesthesia (TIVA) is frequently used due to brain relaxation and less effect on electrophysiologic monitoring. Response to propofol can vary between individuals and be associated with clinical factors including age and weight, and genetic polymorphism. Because the importance of rapid recovery in neurosurgery with long operation time is emphasized recently, the choice and dose adjustment of anesthetics should be determined according to clinical and genetic factors. Recently, researches about genetic variations have been performed with single nucleotide polymorphism (SNP). The aim of this study is to determine SNPs associated with propofol recovery and response in Korean adult population undergoing propofol based TIVA for clipping of unruptured cerebral aneurysm.
- Conditions
- Unruptured Cerebral Aneurysm
- Keywords
- propofol, total intravenous anesthesia, cerebral aneurysm, single nucleotide polymorphism
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| undergoing propofol based TIVA for clip | This study is an observational study performed in adult patients undergoing propofol based TIVA for clipping of unruptured cerebral aneurysm. We will collect data regarding recovery after stopping propofol infusion (time for eye opening and extubation), propofol requirement during anesthesia maintenance, and propofol effect site concentration to achieve bispectral index 40 during anesthesia induction, without doing any interventions. Data collection will be established with just observing and recording values displayed in screens of monitoring devices, and reviewing patient charts. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of eye opening after stopping propofol infusion
Measured: within about one hour from end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2016 (estimated)
- Study start7 Mar 2016
- Primary completion22 Feb 2017
- Study completion22 Feb 2017
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 Unruptured Cerebral AneurysmStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02700126
- Sponsor's protocol ID
- 4-2015-1195
- Status last verified
- Mar 2017
- First submitted
- 26 Feb 2016
- Last updated
- 10 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: no plan to share data
Publications
Iohom G, Ni Chonghaile M, O'Brien JK, Cunningham AJ, Fitzgerald DF, Shields DC. An investigation of potential genetic determinants of propofol requirements and recovery from anaesthesia. Eur J Anaesthesiol. 2007 Nov;24(11):912-9. doi: 10.1017/S0265021507000476. Epub 2007 Jun 7.
PubMed 17555608
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Genetic Polymorphism on Propofol Requirement and Recovery for Total Intravenous Anesthesia for Clipping of Unruptured Cerebral Aneurysm in Korean Population
- ClinicalTrials.gov ID
- NCT02700126
- Acronym / sponsor ID
- 4-2015-1195
- Conditions
- Unruptured Cerebral Aneurysm
- Keywords
- propofol, total intravenous anesthesia, cerebral aneurysm, single nucleotide polymorphism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 7 Mar 2016 (actual)
- Primary completion
- 22 Feb 2017 (actual)
- Study completion
- 22 Feb 2017 (actual)
- First posted
- 7 Mar 2016 (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.
In neurosurgical anesthesia, propofol based total intravenous anesthesia (TIVA) is frequently used due to brain relaxation and less effect on electrophysiologic monitoring. Response to propofol can vary between individuals and be associated with clinical factors including age and weight, and genetic polymorphism. Because the importance of rapid recovery in neurosurgery with long operation time is emphasized recently, the choice and dose adjustment of anesthetics should be determined according to clinical and genetic factors. Recently, researches about genetic variations have been performed with single nucleotide polymorphism (SNP). The aim of this study is to determine SNPs associated with propofol recovery and response in Korean adult population undergoing propofol based TIVA for clipping of unruptured cerebral aneurysm.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| undergoing propofol based TIVA for clip | – | –This study is an observational study performed in adult patients undergoing propofol based TIVA for clipping of unruptured cerebral aneurysm. We will collect data regarding recovery after stopping propofol infusion (time for eye opening and extubation), propofol requirement during anesthesia maintenance, and propofol effect site concentration to achieve bispectral index 40 during anesthesia induction, without doing any interventions. Data collection will be established with just observing and recording values displayed in screens of monitoring devices, and reviewing patient charts. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Korean adult population undergoing propofol based total intravenous anesthesia for clipping of unruptured cerebral aneurysm.
Key inclusion criteria (1 listed)
- 1. Korean adult population undergoing propofol based TIVA for clipping of unruptured cerebral aneurysm
Key exclusion criteria (4 listed)
- patients not able to read, or understand the consent form
- ethnicity, other than Korean population
- patients refusal
- patients not to perform total intravenous anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time of eye opening after stopping propofol infusion
Time frame: within about one hour from end of surgery
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 10 Mar 2017.
- Background: PubMed 17555608Iohom G, Ni Chonghaile M, O'Brien JK, Cunningham AJ, Fitzgerald DF, Shields DC. An investigation of potential genetic determinants of propofol requirements and recovery from anaesthesia. Eur J Anaesthesiol. 2007 Nov;24(11):912-9. doi: 10.1017/S0265021507000476. Epub 2007 Jun 7.
- Individual participant dataSharing planned: No. no plan to share data
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unruptured Cerebral Aneurysm, run by Yonsei University 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 1 inclusion and 4 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 10 Mar 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.
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?
Time of eye opening after stopping propofol infusion (time frame: within about one hour from end of surgery). 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 NCT02700126, 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 10 Mar 2017.