Brain TumorNCT04585633
Postoperative Risk Prediction Score After Elective Intracranial Neurosurgery Operation
An observational study of Brain Tumor and Post-Op Complication, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study is to prevent unnecessary intensive care unit hospitalizations by developing a scoring system to detect low-risk patients after elective intracranial neurosurgery operation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumor, Post-Op Complication, Anesthesia
- What is being tested?
- Quality of Recovery-15, Glasgow Result Scale and Risk Factors
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2022to 1 Jan 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: It is planned to include intracranial operations performed by craniotomy in a 2-year period by Trakya University Faculty of Medicine, Department of Neurosurgery.
Who may be able to join
- To undergo intracranial operation with elective craniotomy
- No history of congestive heart failure
- No kidney and liver dysfunction
- Not pregnant
- To be over 18 years old
Who cannot join
- To undergo an intracranial operation with emergency craniotomy
- Patients with a history of congestive heart failure
- Patients with kidney and liver dysfunction
- Pregnant patients
- Patients under 18 years old
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Trakya University
Edirne, Centrum, 22030
ONUR KÜÇÜK, Resident, +905358543333, dr.okucuk@gmail.com
SEVTAP HEKİMOĞLU ŞAHİN, Professor, sevtaphekimoglu@yahoo.com
About this study
The aim of our study is to prevent unnecessary intensive care unit hospitalizations by developing a scoring system to detect low-risk patients after elective intracranial neurosurgery operation.
Read the detailed description
In this study, the data of patients who are planned to undergo craniotomy by neurosurgery will be collected as a file scan (medical histories, drugs used, demographic features, additional diseases, ASA class, pre-operative routine parameters, operation history, GCS, tumor histology, location, dimensions and intracerebral radiological data, laboratory values). The pre-operative Quality of Recovery-15 (QoR-15) score will be recorded before the patient is taken into operation. Intraoperative; hemodynamic data of patients; highest and lowest values of heart rate, diastolic, systolic and mean arterial pressures, fluid and blood products given, anesthetic and other drugs administered, duration of anesthesia, duration of surgery, surgical position, blood loss, urine output and blood gas samples will be written from the anesthesia document after the operation is over. For the study, the application of the anesthesiologist for the patient will not be interfered. After the operation; extubation time, MAS score, use of mechanical ventilation, post-operative complications (moderate to severe intracerebral hemorrhage on brain CT, intracranial hypertension requiring post op surgical drainage, development of status epilepticus or seizures, the need for tracheal intubation and mechanical ventilation after surgery, decrease in GKS, unmanageable agitation that requires restriction or sedation, need for respiratory failure and oxygen therapy, serious motor deficit and exitus) will be recorded in the service where the patient is sent. The post-operative QoR-15 score will be calculated 24 hours after the operation. Pre-operative and post-operative calculated scores of the patient will be evaluated and anesthesia recovery score will be created. With this recovery score, post-operative mortality and morbidity estimates will be made. The length of hospital stay of the patient will be recorded. Glasgow Result Scale (GOS) score will be determined 30 days after the patient operation. In this way, 1 month morbidity and mortality of the patient will be evaluated. The collected results will be statistically associated with anesthesia recovery and operation complications.
As a result, in our study; post-operative risk prediction score will be created in patients undergoing intracranial surgery with elective craniotomy.
- Conditions
- Brain Tumor, Post-Op Complication, Anesthesia
- Being tested
- Quality of Recovery-15, Glasgow Result Scale, Risk Factors
- Keywords
- craniotomy, Quality of Recovery, post-operative, risk prediction score, anesthesia recovery
- Medical subject headings
- Brain Neoplasms, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of Recovery-15Other
Also called QoR-15
Quality of Recovery-15 is a scale consisting of 15 questions indicating the recovery quality of the patient after anesthesia and a score between 0-150.
Glasgow Result ScaleOther
Also called GOS
Glasgow Outcome Scale; It is a scale developed to categorize people suffering from head trauma or non-traumatic acute brain injury into broad outcome categories. It shows postoperative mortality and morbidity of patients who underwent intracranial surgery.
Risk FactorsOther
Pre-operative: medical histories, drugs used, demographic features, additional diseases, ASA class, pre-operative routine parameters, operation history, GCS, tumor histology, location, dimensions and intracerebral radiological data, laboratory values Intraoperative; hemodynamic data of patients; highest and lowest values of heart rate, diastolic, systolic and mean arterial pressures, fluid and blood products given, anesthetic and other drugs administered, duration of anesthesia, duration of surgery, surgical position, blood loss, urine output and blood gas samples Post-operation; extubation time, MAS score, use of mechanical ventilation, post-operative complications, hemodynamic data, blood gas data
| Study group | Role | What they receive |
|---|---|---|
| Low Risk | no complication develop within 30 days after the operation and high GOS value Receives: Other: Quality of Recovery-15; Other: Glasgow Result Scale; Other: Risk Factors | |
| High Risk | complication or complications develop within 30 days after the operation and low GOS value
Complications:
* Moderate to severe intracerebral hemorrhage confirmed in a brain CT scan (Midline shift in brain imaging ≥ 3 mm),
* İntracranial hypertension requiring post op surgical drainage,
* Status epilepticus or seizures,
* The need for tracheal intubation or use of mechanical ventilation after surgery,
* Decrease in GKS,
* Unmanageable agitation that requires restriction or sedation,
* Need for respiratory failure and oxygen therapy,
* Unexpected serious motor deficit
* Died Receives: Other: Quality of Recovery-15; Other: Glasgow Result Scale; Other: Risk Factors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery-15
Quality of Recovery-15 is a scale consisting of 15 questions indicating the recovery quality of the patient after anesthesia and a score between 0-150.
Measured: score change before surgery and 24 hours after surgery
Secondary outcomes (2)
Complication
the development of complication or complications during hospitalization
Complications:
- Moderate to severe intracerebral hemorrhage confirmed in a brain CT scan (Midline shift in brain imaging ≥ 3 mm),
- İntracranial hypertension requiring post op surgical drainage,
- Status epilepticus or seizures,
- The need for tracheal intubation or use of mechanical ventilation after surgery,
- Decrease in GKS,
- Unmanageable agitation that requires restriction or sedation,
- Need for respiratory failure and oxygen therapy,
- Unexpected serious motor deficit
- Died
Measured: during the hospital stay
Glasgow Outcome Scale
Glasgow Outcome Scale; It is a scale developed to categorize people suffering from head trauma or non-traumatic acute brain injury into broad outcome categories. It shows postoperative mortality and morbidity of patients who underwent intracranial surgery. Glasgow Outcome Scale is a five-point scale. 1 point is considered death and five points as good recovery. As the score increases, morbidity and mortality decrease.
Measured: 30th day after the operation (1 time)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start1 Jul 2022
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Onur Kucuk, Trakya University
- Investigators
- SEVTAP HEKİMOĞLU ŞAHİN, Professor, Principal investigator, Trakya UniversityONUR KÜÇÜK, Resident, Principal investigator, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04585633
- Sponsor's protocol ID
- TÜTF-BAEK 2020/136
- Status last verified
- Nov 2023
- First submitted
- 4 Aug 2020
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Risk Prediction Score After Elective Intracranial Neurosurgery Operation
- ClinicalTrials.gov ID
- NCT04585633
- Acronym / sponsor ID
- TÜTF-BAEK 2020/136
- Conditions
- Brain Tumor, Post-Op Complication, Anesthesia
- Keywords
- craniotomy, Quality of Recovery, post-operative, risk prediction score, anesthesia recovery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 14 Oct 2020 (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 our study is to prevent unnecessary intensive care unit hospitalizations by developing a scoring system to detect low-risk patients after elective intracranial neurosurgery operation.
Detailed description
In this study, the data of patients who are planned to undergo craniotomy by neurosurgery will be collected as a file scan (medical histories, drugs used, demographic features, additional diseases, ASA class, pre-operative routine parameters, operation history, GCS, tumor histology, location, dimensions and intracerebral radiological data, laboratory values). The pre-operative Quality of Recovery-15 (QoR-15) score will be recorded before the patient is taken into operation. Intraoperative; hemodynamic data of patients; highest and lowest values of heart rate, diastolic, systolic and mean arterial pressures, fluid and blood products given, anesthetic and other drugs administered, duration of anesthesia, duration of surgery, surgical position, blood loss, urine output and blood gas samples will be written from the anesthesia document after the operation is over. For the study, the application of the anesthesiologist for the patient will not be interfered. After the operation; extubation time, MAS score, use of mechanical ventilation, post-operative complications (moderate to severe intracerebral hemorrhage on brain CT, intracranial hypertension requiring post op surgical drainage, development of status epilepticus or seizures, the need for tracheal intubation and mechanical ventilation after surgery, decrease in GKS, unmanageable agitation that requires restriction or sedation, need for respiratory failure and oxygen therapy, serious motor deficit and exitus) will be recorded in the service where the patient is sent. The post-operative QoR-15 score will be calculated 24 hours after the operation. Pre-operative and post-operative calculated scores of the patient will be evaluated and anesthesia recovery score will be created. With this recovery score, post-operative mortality and morbidity estimates will be made. The length of hospital stay of the patient will be recorded. Glasgow Result Scale (GOS) score will be determined 30 days after the patient operation. In this way, 1 month morbidity and mortality of the patient will be evaluated. The collected results will be statistically associated with anesthesia recovery and operation complications.
As a result, in our study; post-operative risk prediction score will be created in patients undergoing intracranial surgery with elective craniotomy.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Risk | – | Other: Quality of Recovery-15, Other: Glasgow Result Scale, Other: Risk Factorsno complication develop within 30 days after the operation and high GOS value |
| High Risk | – | Other: Quality of Recovery-15, Other: Glasgow Result Scale, Other: Risk Factorscomplication or complications develop within 30 days after the operation and low GOS value Complications: * Moderate to severe intracerebral hemorrhage confirmed in a brain CT scan (Midline shift in brain imaging ≥ 3 mm), * İntracranial hypertension requiring post op surgical drainage, * Status epilepticus or seizures, * The need for tracheal intubation or use of mechanical ventilation after surgery, * Decrease in GKS, * Unmanageable agitation that requires restriction or sedation, * Need for respiratory failure and oxygen therapy, * Unexpected serious motor deficit * Died |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- It is planned to include intracranial operations performed by craniotomy in a 2-year period by Trakya University Faculty of Medicine, Department of Neurosurgery.
Key inclusion criteria (5 listed)
- To undergo intracranial operation with elective craniotomy
- No history of congestive heart failure
- No kidney and liver dysfunction
- Not pregnant
- To be over 18 years old
Key exclusion criteria (5 listed)
- To undergo an intracranial operation with emergency craniotomy
- Patients with a history of congestive heart failure
- Patients with kidney and liver dysfunction
- Pregnant patients
- Patients under 18 years old
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 |
|---|---|---|
| Quality of Recovery-15Also: QoR-15Quality of Recovery-15 is a scale consisting of 15 questions indicating the recovery quality of the patient after anesthesia and a score between 0-150. | Other | High Risk, Low Risk |
| Glasgow Result ScaleAlso: GOSGlasgow Outcome Scale; It is a scale developed to categorize people suffering from head trauma or non-traumatic acute brain injury into broad outcome categories. It shows postoperative mortality and morbidity of patients who underwent intracranial surgery. | Other | High Risk, Low Risk |
| Risk FactorsPre-operative: medical histories, drugs used, demographic features, additional diseases, ASA class, pre-operative routine parameters, operation history, GCS, tumor histology, location, dimensions and intracerebral radiological data, laboratory values Intraoperative; hemodynamic data of patients; highest and lowest values of heart rate, diastolic, systolic and mean arterial pressures, fluid and blood products given, anesthetic and other drugs administered, duration of anesthesia, duration of surgery, surgical position, blood loss, urine output and blood gas samples Post-operation; extubation time, MAS score, use of mechanical ventilation, post-operative complications, hemodynamic data, blood gas data | Other | High Risk, Low Risk |
Primary outcome
Quality of Recovery-15
Time frame: score change before surgery and 24 hours after surgery
Quality of Recovery-15 is a scale consisting of 15 questions indicating the recovery quality of the patient after anesthesia and a score between 0-150.
2 secondary outcomes
Complication
Time frame: during the hospital stay
Glasgow Outcome Scale
Time frame: 30th day after the operation (1 time)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Individual participant dataSharing planned: No
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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 HEKİMOĞLU ŞAHİN, Professor principal investigator
Trakya University
ONUR KÜÇÜK, Resident 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?
An observational study of Brain Tumor and Post-Op Complication, 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 5 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 7 Nov 2023. 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 ONUR KÜÇÜK, Resident (05358543333 ext. +9, dr.okucuk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Recovery-15 (time frame: score change before surgery and 24 hours after surgery). 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 7 Nov 2023.