Unruptured Cerebral AneurysmNCT03087383
Identification of Genetic Polymorphisms Related to Propofol Requirement and Recovery Through Genome-wide Association Study (GWAS) in 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
- 500 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Mar 2017to Mar 2020
- 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
- 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
- Patients currently taking psychiatric medication
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine
Seoul, 03722
Seung Ho Choi, MD, +82 2 2228-2427, csho99@yuhs.ac
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 find SNPs associated with propofol recovery and response through genome-wide association study (GWAS) in Korean adult population undergoing propofol based TIVA for clipping of unruptured cerebral aneurysm.
- Conditions
- Unruptured Cerebral 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 |
|---|---|---|
| Prospective Cohort | In adult patients undergoing propofol based TIVA for clipping of unruptured cerebral aneurysm, investigator 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. | |
| Retrospective Cohort | In previous study performed in adult patients undergoing propofol based TIVA for clipping of unruptured cerebral aneurysm (NCT02700126, 4-2015-1195), investigator enrolled patients and collected 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. |
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
When operation is finished, investigator will stop the intravenous infusion of propofol. Investigators will measure the time from when propofol infusion is stopped until eye opening and extubation, respectively. The measurement will be established within about one hour from end of surgery.
Measured: Within one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study start2 Mar 2017
- Primary completionMar 2020 (estimated)
- Study completionMar 2020 (estimated)
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
- Other
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03087383
- Sponsor's protocol ID
- 4-2017-0008
- Status last verified
- Mar 2019
- First submitted
- 7 Mar 2017
- Last updated
- 18 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 18 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Genetic Polymorphisms Related to Propofol Requirement and Recovery Through Genome-wide Association Study (GWAS) in Total Intravenous Anesthesia for Clipping of Unruptured Cerebral Aneurysm in Korean Population
- ClinicalTrials.gov ID
- NCT03087383
- Acronym / sponsor ID
- 4-2017-0008
- Conditions
- Unruptured Cerebral Aneurysm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 2 Mar 2017 (actual)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 22 Mar 2017 (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.
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 find SNPs associated with propofol recovery and response through genome-wide association study (GWAS) in Korean adult population undergoing propofol based TIVA for clipping of unruptured cerebral aneurysm.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective Cohort | – | –In adult patients undergoing propofol based TIVA for clipping of unruptured cerebral aneurysm, investigator 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. |
| Retrospective Cohort | – | –In previous study performed in adult patients undergoing propofol based TIVA for clipping of unruptured cerebral aneurysm (NCT02700126, 4-2015-1195), investigator enrolled patients and collected 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. |
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)
- Korean adult population undergoing propofol based TIVA for clipping of unruptured cerebral aneurysm
Key exclusion criteria (5 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
- Patients currently taking psychiatric medication
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 one hour
When operation is finished, investigator will stop the intravenous infusion of propofol. Investigators will measure the time from when propofol infusion is stopped until eye opening and extubation, respectively. The measurement will be established within about one hour from end of surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2019.
- 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
Related trials for Unruptured Cerebral Aneurysm
RecruitingObservational study
A Study of Choydar Flow-Directed Mesh Stent in the Treatment of Unruptured Intracranial Aneurysms
Intracranial Aneurysm
Not yet recruiting
Effect of Bilateral Greater Occipital Nerve Block on Headache After Intracranial Aneurysm Coiling
Intracranial Aneurysm, Postoperative Pain
RecruitingObservational study
Evaluation of Intestinal Microbiota Implication in Ruptured Intracranial Aneurysm
Intracranial Sacciform Aneurysm
Not yet recruitingPhase 4
Efficacy and Safety of Methylprednisolone After Flow-Diverter Stent Implantation in Unruptured Intracranial Aneurysms
Unruptured Intracranial Aneurysms, Cerebrovascular Event
Recruiting
Safety and Efficacy of Endovascular Treatment of Intracranial Aneurysms With Surpass Elite With GUARDian Flow Diverter (GUARD)
Aneurysm, Aneurysm, Intracranial
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.
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 5 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 18 Mar 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seung Ho Choi, MD (+82 2 2228-2427, csho99@yuhs.ac), or a site near the patient. 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 one hour). 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 NCT03087383, 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 18 Mar 2019.