Epileptic SeizureNCT03123302
Our Anesthesia Experience During MRI Scan
An observational study of Epileptic Seizure and Intracranial Tumor, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
In this study we aim to investigate the relationship between our anesthesia practice and post procedure complications after MRI scanning with sedation. This is a retrospective, single center observational study. All patients undergoing MRI scan during the study period will be included. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Epileptic Seizure, Intracranial Tumor, Intracranial Hypertension
- How many people
- 977 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2017to 8 Feb 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients undergoing MRI scan wth sedation anesthesia and giving written informed consent.
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
In this study we aim to investigate the relationship between our anesthesia practice and post procedure complications after MRI scanning with sedation. This is a retrospective, single center observational study. All patients undergoing MRI scan during the study period will be included.
Read the detailed description
In this study we aim to investigate the influence of patient characteristics and anesthesia choice on possible complications in patients undergoing MRI under sedation retrospectively.
After one of the routine sedation protocol used in our department was chosen and applied according to the physical status of the patient and the physicians decision, the datas of the patients will be recruited to the study from the medical records . Patient characteristics (age, gender, weight, height), ASA (American Society of Anethesiology) classification, associated diseases will be recorded . After the procedure was completed all the complications during the 2 hours waiting period in the recovery room will be recorded from the medical records. All the complşcation and recovery times will be recorded from the medical records. Whether the patient received radiocontrast material or not will also be recorded. The patients will be called by phone, and will be questioned for the complications, any epileptic seizure attack, or increase in the number of seizures, any admission to emergency room or any in patient admission to the hospital will be recorded which developed in the first week after the procedure.
- Conditions
- Epileptic Seizure, Intracranial Tumor, Intracranial Hypertension, Intracranial Aneurysm, Vertebra; Anomaly
- Keywords
- MRI scan, sedation, epilepsia
- Medical subject headings
- Seizures, Brain Neoplasms, Intracranial Hypertension, Intracranial Aneurysm, Congenital Abnormalities, Epilepsy
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 |
|---|---|---|
| Group 1 | Epileptic patients who are sedated with a total dose of propofol 2 mg/kg and midazolam 0.1 mg/kg. | |
| Group 2 | Epileptic patients who are sedated with a total dose of pentothal 4 mg/kg and midazolam 0.1 mg/kg. | |
| Group 3 | Non-epileptic patients who are sedated with a total dose of propofol 1 mg/kg and ketamine 1 mg/kg. | |
| Group 4 | Non-epileptic patients who are sedated with a total dose of midazolame 0.1 mg/kg and ketamine 1 mg/kg. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient characteristics anesthesia choice and possible complications during MRI anesthesia.
To investigate the influence of patient characteristics and anesthesia choice on possible complications of sedation anesthesia during MRI scanning
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start1 Feb 2017
- Primary completion1 Feb 2018
- Study completion8 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epileptic SeizureStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 977 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlker Onguc Aycan, Akdeniz University
- Investigators
- Ilker O Aycan, MD, Principal investigator, Akdeniz University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03123302
- Sponsor's protocol ID
- MEDAH
- Status last verified
- Jun 2020
- First submitted
- 18 Apr 2017
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Our Anesthesia Experience During MRI Scan
- ClinicalTrials.gov ID
- NCT03123302
- Acronym / sponsor ID
- MEDAH
- Conditions
- Epileptic Seizure, Intracranial Tumor, Intracranial Hypertension, Intracranial Aneurysm, Vertebra; Anomaly
- Keywords
- MRI scan, sedation, epilepsia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 977 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 8 Feb 2018 (actual)
- First posted
- 21 Apr 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 this study we aim to investigate the relationship between our anesthesia practice and post procedure complications after MRI scanning with sedation. This is a retrospective, single center observational study. All patients undergoing MRI scan during the study period will be included.
Detailed description
In this study we aim to investigate the influence of patient characteristics and anesthesia choice on possible complications in patients undergoing MRI under sedation retrospectively.
After one of the routine sedation protocol used in our department was chosen and applied according to the physical status of the patient and the physicians decision, the datas of the patients will be recruited to the study from the medical records . Patient characteristics (age, gender, weight, height), ASA (American Society of Anethesiology) classification, associated diseases will be recorded . After the procedure was completed all the complications during the 2 hours waiting period in the recovery room will be recorded from the medical records. All the complşcation and recovery times will be recorded from the medical records. Whether the patient received radiocontrast material or not will also be recorded. The patients will be called by phone, and will be questioned for the complications, any epileptic seizure attack, or increase in the number of seizures, any admission to emergency room or any in patient admission to the hospital will be recorded which developed in the first week after the procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Epileptic patients who are sedated with a total dose of propofol 2 mg/kg and midazolam 0.1 mg/kg. |
| Group 2 | – | –Epileptic patients who are sedated with a total dose of pentothal 4 mg/kg and midazolam 0.1 mg/kg. |
| Group 3 | – | –Non-epileptic patients who are sedated with a total dose of propofol 1 mg/kg and ketamine 1 mg/kg. |
| Group 4 | – | –Non-epileptic patients who are sedated with a total dose of midazolame 0.1 mg/kg and ketamine 1 mg/kg. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients undergoing MRI scan wth sedation anesthesia and giving written informed consent.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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
Patient characteristics anesthesia choice and possible complications during MRI anesthesia.
Time frame: 1 week
To investigate the influence of patient characteristics and anesthesia choice on possible complications of sedation anesthesia during MRI scanning
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 4 Jun 2020.
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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.
Ilker O Aycan, MD principal investigator
Akdeniz University Hospital
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 Epileptic Seizure and Intracranial Tumor, run by Akdeniz University at 1 site in Turkey (Türkiye).
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 0 inclusion and 1 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 4 Jun 2020. 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 Turkey (Türkiye). 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?
Patient characteristics anesthesia choice and possible complications during MRI anesthesia. (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2020.