Intracranial NeoplasmOxygenationNCT03714347
The Effect of Cerebral Oxygenation on Postoperative Recovery in Intracranial Surgery
A study testing cerebral oxygen monitoring and routine monitoring in people with Intracranial Neoplasm, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the effect of cerebral oxygenation on postoperative compilation in intracranial surgery. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Intracranial Neoplasm
- What is being tested?
- cerebral oxygen monitoring and routine monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Dec 2016to Jan 2019
- 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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Intracranial surgery will be performed
- Age 25-75
- ASA in the I-II-III risk group
Who cannot join
- Under GKS 15
- heart failure,
- renal insufficiency,
- liver failure,
- congenital neurological deficits
Trial locations and contacts
1 site in 1 country.
Sevtap Hekimoglu Sahin, Professor contact
Beyhan Karamanlıoglu, professor contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Trakya University
Edirne, Centrum, 22030
Sevtap Hekimoglu Sahin, Professor, sevtaphekimoglu@mynet.com
Beyhan Karamanlıoglu, Professor, beykar@mynet.com
About this study
The aim of this study was to investigate the effect of cerebral oxygenation on postoperative compilation in intracranial surgery.
Read the detailed description
Patients undergoing intracranial surgery will be divided into two groups; group (Group Control n = 100) and cerebral oxygenation monitoring group (Group Oxygen). all hemodynamic parameters such as systolic blood pressure and diastolic blood pressure, oxygen saturation, Et CO2, SpO2;% and BIS during anesthesia during anesthesia will be recorded intraoperatively and 10 postoperatively in 5 min intervals. After extubation, Modified Aldrete Score, GKS (Glasgow Coma Scale), Ramsey Sedation Scale (RSS), nausea-vomiting and pain will be recorded in the recovery room. Pain assessment will be done with Visual Analog Scale (VAS). Patient satisfaction will be recorded. MMST (mini mental state test) and ASEM (antisaccadic eye movement test) tests will be performed preoperatively and postoperatively at 1st, 2nd and 3rd days.
- Conditions
- Intracranial Neoplasm
- Being tested
- cerebral oxygen monitoring, routine monitoring
- Keywords
- cerebral oxygen monitoring, intracranial surgery, general anesthesia
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cerebral oxygen monitoringDevice
probes will be placed on eyebrows on forehead
routine monitoringDevice
We will use routine monitoring intervention such as hate rate, arterial pressure, BIS. cerebral oxygen monitoring will not be applied to this group
| Study group | Role | What they receive |
|---|---|---|
| Group Control | Active comparator | routine monitoring will be applied to this group Receives: Device: routine monitoring |
| Group Oxygen | Active comparator | cerebral oxygen monitoring is applied to this group Receives: Device: cerebral oxygen monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
cerebral oxygen monitoring data
cerebral oxygen monitoring will measure peroperative
Measured: cerebral oxygen values reported will be measured at 10 min intervals (intraoperative) and It would be reported by the first postoperative 10 minute intervals up to 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start28 Dec 2016
- Primary completionDec 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial NeoplasmStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevtap Hekimoglu Sahin, Trakya University
- Investigators
- Emre Deren, MD, Principal investigator, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03714347
- Sponsor's protocol ID
- TÜTF-BAEK 2016/225
- Other IDs
- TÜTF-BAEK
- Acronym
- Oxygenation
- Status last verified
- Oct 2018
- First submitted
- 18 Oct 2018
- Last updated
- 22 Oct 2018
- 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 22 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cerebral Oxygenation on Postoperative Recovery in Intracranial Surgery
- ClinicalTrials.gov ID
- NCT03714347
- Acronym / sponsor ID
- Oxygenation / TÜTF-BAEK 2016/225
- Conditions
- Intracranial Neoplasm
- Keywords
- cerebral oxygen monitoring, intracranial surgery, general anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 28 Dec 2016 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 22 Oct 2018 (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.
The aim of this study was to investigate the effect of cerebral oxygenation on postoperative compilation in intracranial surgery.
Detailed description
Patients undergoing intracranial surgery will be divided into two groups; group (Group Control n = 100) and cerebral oxygenation monitoring group (Group Oxygen). all hemodynamic parameters such as systolic blood pressure and diastolic blood pressure, oxygen saturation, Et CO2, SpO2;% and BIS during anesthesia during anesthesia will be recorded intraoperatively and 10 postoperatively in 5 min intervals. After extubation, Modified Aldrete Score, GKS (Glasgow Coma Scale), Ramsey Sedation Scale (RSS), nausea-vomiting and pain will be recorded in the recovery room. Pain assessment will be done with Visual Analog Scale (VAS). Patient satisfaction will be recorded. MMST (mini mental state test) and ASEM (antisaccadic eye movement test) tests will be performed preoperatively and postoperatively at 1st, 2nd and 3rd days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Control | Active comparator | Device: routine monitoringroutine monitoring will be applied to this group |
| Group Oxygen | Active comparator | Device: cerebral oxygen monitoringcerebral oxygen monitoring is applied to this group |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Intracranial surgery will be performed
- Age 25-75
- ASA in the I-II-III risk group
Key exclusion criteria (5 listed)
- Under GKS 15
- heart failure,
- renal insufficiency,
- liver failure,
- congenital neurological deficits
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 |
|---|---|---|
| cerebral oxygen monitoringprobes will be placed on eyebrows on forehead | Device | Group Oxygen |
| routine monitoringWe will use routine monitoring intervention such as hate rate, arterial pressure, BIS. cerebral oxygen monitoring will not be applied to this group | Device | Group Control |
Primary outcome
cerebral oxygen monitoring data
Time frame: cerebral oxygen values reported will be measured at 10 min intervals (intraoperative) and It would be reported by the first postoperative 10 minute intervals up to 30 minutes
cerebral oxygen monitoring will measure peroperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2018.
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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.
Sevtap Hekimoglu Sahin, Professor contact
Beyhan Karamanlıoglu, professor contact
Emre Deren, MD principal investigator
Trakya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cerebral oxygen monitoring and routine monitoring in people with Intracranial Neoplasm, run by Trakya 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 3 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 22 Oct 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sevtap Hekimoglu Sahin, Professor (sevtaphekimoglu@mynet.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cerebral oxygen monitoring data (time frame: cerebral oxygen values reported will be measured at 10 min intervals (intraoperative) and It would be reported by the first postoperative 10 minute intervals up to 30 minutes). 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 22 Oct 2018.