Neurocognitive DisorderNCT06685770
EVALUATION OF POSTOPERATIVE NEUROCOGNITIVE IMPAIRMENT
An observational study of Neurocognitive Disorder and General Anesthesia, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this prospective study, the effects of different anesthesia methods (total intravenous anesthesia and inhaled anesthesia) on neurocognitive function will be examined in patients undergoing breast-conserving surgery without axillary lymph node dissection. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Neurocognitive Disorder, General Anesthesia, Total Intravenous Anesthesia
- What is being tested?
- Mini mental state assessment test and Mini-cog test
- Type of treatment
- Injection or infusion
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Nov 2024to 15 May 2025
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female patients who applied to the general surgery clinic of Haseki Training and Research Hospital due to the diagnosis of early stage breast cancer (stage 1-2) and planned breast-conserving surgery (mass removal only) will be included in this study. Since the neurocognitive status assessment will be made precisely in these patients, diseases and factors affecting the neurological status will be recorded as non-study factors and these patients will be excluded from the study. Preoperative anxiety scores, comorbidities and regular medications of the patients included in the study will also be recorded.
Who may be able to join
- Female patients with early stage breast cancer who will undergo breast-conserving surgery
Who cannot join
- Patients receiving neoadjuvant radiotherapy and chemotherapy
- Patients who will undergo axillary lymph dissection and total mastectomy
- Asa 4-5 patients
- Patients without voluntary consent
- Patients with previous surgery or vertebrobasilar insufficiency
- Patients with Carotis stenosis
Show all 22Show fewer
- Patients with a visual analog scale above 4 in the postoperative recovery unit
- Patients in whom cerebral oxygenation decreased by 15% from the beginning in cerebral oximetry monitoring during the perioperative period
- Patients with bleeding that disrupts hemodynamics during follow-up and bleeding greater than 20% of body volume
- Patients with postoperative intensive care unit follow-up
- Patients with a decrease of more than 20% from the baseline systolic value (based on ward monitoring) during follow-up
- Patients with intraoperative ventilation failure, patients with hypercarbia, hypocarbia
- Patients whose Patient State Index value falls below 25, which is sufficient for the depth of anesthesia, during anesthesia induction or maintenance.
- Patients with known neurological, psychiatric, unstable cardiovascular, renal or hepatic system disease
- Patients with Uncontrolled Hypertension
- Patients with greater than 1st degree heart block
- Patients allergic to α2 adrenergic receptor agonist
- Patients who cannot speak and do not know Turkish
- Alcohol and substance addicted patients
- Patients who have used opioids in the last 24 hours
- Patients who developed sepsis during postoperative follow-up
- Patients with a history of recurrent surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Haseki Training and Research Hospital
Istanbul, 34265
About this study
Official title: THE EFFECT OF PEROPERATIVE TOTAL INTRAVENOUS ANESTHESIA AND INHALER ANESTHESIA ON POSTOPERATIVE NEUROCGNITIVE DISORDER IN BREAST CANCER SURGERY
In this prospective study, the effects of different anesthesia methods (total intravenous anesthesia and inhaled anesthesia) on neurocognitive function will be examined in patients undergoing breast-conserving surgery without axillary lymph node dissection. Mini-Mental State Examination and Mini-Cog tests will be administered at specific intervals pre and postoperatively. Anesthesia management will follow standard protocols, and the researcher will not intervent in these processes. The relationship between the type of anesthesia and neurocognitive outcomes will be evaluated based on the collected data.
Read the detailed description
During the preoperative evaluation process, after identifying patients with breast cancer who will undergo breast-conserving surgery and who will not undergo axillary lymph dissection, who meet the inclusion criteria in the study, neurocognitive evaluations of these patients will be performed by the anesthesiologist with the mini-mental state assessment (MMDD) test and Mini-cog test 24 hours before the preoperative period. These two tests will be repeated by the same doctor in the preoperative waiting room on the day of the operation.
From the preoperative waiting room, patients will be taken to the operation room after premedication with 2mg intravenous midazolam. After all patients are monitored with standard American Society of Anesthesia monitoring (heart rate, peripheral saturation, noninvasive artery monitoring) and electro encephalography monitoring (patient state index (PSI)), the initial values will be recorded before surgery. During induction, 1-2mg/kg propofol, 2mcg/kg Fentanyl and 0.8mg/kg rocuronium will be administered and then the patient will be intubated. Patients will be monitored to be normothermic by body temperature monitoring. If peroperative heart rate and noninvasive arterial pressure values increase by more than 20% of the presurgical basal value, remifentanil will be administered as an intravenous infusion between 0.05-2mcg/kg/min to all patients. During the peroperative period, noninvasive arterial pressure values, saturation values, heart rate, Patient state index values, Suppression rates and times, body temperature values will be recorded on the follow up form as values before the operation, at the beginning of the operation, at 30minute intervals from the beginning of the operation, and before and after extubation at the end of the operation. During surgery, peroperative anesthesia management will be determined as the ideal anesthesia method for the patient, as deemed appropriate by the relevant anesthesiologist, and there will be no intervention by the anesthesiologist performing the neurocognitive evaluation.
Heart Rate, saturation, noninvasive arterial pressure values will be recorded upon entry and exit from the postoperative recovery unit. Postoperative pain monitoring will be done with Visual analog scala(VAS), and to patients with a Visual analog scala value above 3, Tramadol 100mg every 6 hours, Nonsteroidal anti-inflammatory 100mg every 6 hours, and paracetamol 1000mg every 6 hours will be given intravenously if necessary. MMDD test and Mini-cog test will be repeated in all patients by the anesthesiologist just before being transferred from the postoperative recovery unit to the ward and at the 24th hour, 3rd day, and 5th day postoperatively.
After all neurocognitive evaluations of the patients are performed at planned intervals for 1 week, which anesthesia method was applied to the patients in the peroperative period will be determined from the anesthesia follow-up sheet and the total time and amount used will be recorded. Patients who underwent total intravenous anesthesia and inhaler anesthesia will be included in the study. Patients whose anesthesia management is changed during the case will be considered excluded from the study. Anesthesia management of patients during the preoperative and peroperative periods will be planned and implemented as deemed appropriate by the anesthesiologist who follows the patient during the surgery, regardless of this planned study. The researcher performing the neurocognitive evaluation will not have any intervention or knowledge in these processes. The reason why this study was planned as a prospective study is that neurocognitive evaluations are performed prospectively. There will be no intervention in the patient's preoperative, peroperative and postoperative anesthesia management.
At the end of the study, the relationship between neurocognitive values and total intravenous anesthesia and inhaled anesthetics will be compared.
- Conditions
- Neurocognitive Disorder, General Anesthesia, Total Intravenous Anesthesia, Sevoflurane Anaesthesia, Breast Surgery
- Being tested
- Mini mental state assessment test, Mini-cog test
- Keywords
- neurocognitive disorder, general anesthesia, mini mental state assessment, mini-cog test
- Medical subject headings
- Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini mental state assessment testOther
Also called neurocognitive assessment test
Breast cancer is a very common and important disease in the female population around the world. Anesthesia management during surgery for this disease in the postoperative period should be carefully planned. It will be important to examine the neurocognitive effects of anesthesia management in the postoperative period in this patient group. Today, inhaler and total intravenous anesthesia have advantages as well as disadvantages. It would be valuable to examine its neurocognitive effects in this patient group. In this study, the frequently used Mini mental state assessment test and Mini-cog test will be used.With mini mental state assessment, the patient is asked a number of simple questions to evaluate cognitive functions and each question has certain points. Changes in these score levels preoperatively and postoperatively will be compared within each patient. At the end of the study, preoperative and postoperative changes will be compared statistically between the groups.
Mini-cog testOther
Also called neurocognitive assessment test
Breast cancer is a very common and important disease in the female population around the world. Anesthesia management during surgery for this disease in the postoperative period should be carefully planned. It will be important to examine the neurocognitive effects of anesthesia management in the postoperative period in this patient group. Today, inhaler and total intravenous anesthesia have advantages as well as disadvantages. It would be valuable to examine its neurocognitive effects in this patient group. In this study, the frequently used Mini-cog test will be used.With Mini-cog test, the patient is asked a number of simple questions to evaluate cognitive functions and each question has certain points. Changes in these score levels preoperatively and postoperatively will be compared within each patient. At the end of the study, preoperative and postoperative changes will be compared statistically between the groups.
| Study group | Role | What they receive |
|---|---|---|
| total intravenous anesthesia groups | In this study, neurological evaluation tests will be performed before and after surgery for patients who will undergo surgery for breast cancer. All patients will be followed during the perioperative period according to the standards specified in the American Society of Anesthesia guideline. Neurological evaluations will be performed at the 24th hour before surgery, on the day of surgery, and on the 1st, 3rd and 5th days after surgery. Those who underwent total intravenous anesthesia after peroperative anesthesia management will constitute this group. The total amounts of propofol and remifentanil consumed in this group will be recorded. Receives: Other: Mini mental state assessment test; Other: Mini-cog test | |
| inhaled anesthesia groups | In this study, neurological evaluation tests will be performed before and after surgery for patients who will undergo surgery for breast cancer. All patients will be followed during the perioperative period according to the standards specified in the American Society of Anesthesia guideline. Neurological evaluations will be performed at the 24th hour before surgery, on the day of surgery, and on the 1st, 3rd and 5th days after surgery. Those who received inhaler anesthesia after peroperative anesthesia management will constitute this group. In this group, Minimal alveolar concentration levels of sevoflurane and total amounts of remifentanil will be recorded. Receives: Other: Mini mental state assessment test; Other: Mini-cog test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in Mini Mental State Assessment test
Female patients who will undergo breast cancer surgery will be given a mini mental state assessment test at the preoperative 24th hour, before and after surgery, and on the 1st, 3rd, and 5th postoperative days. In this test, the patient's neurocognitive status will be evaluated by asking simple questions that investigate their mental characteristics. Each question has a score and the total score indicates the patient's condition. In these patients, this test will be repeated at regular intervals after surgery and postoperatively and the results will be recorded.High scores on this test indicate good neurological stability, whereas falling is associated with poor neurological status. Changed in the value as a result of this test will be investigated.
Measured: Preoperative 24 hours before, in the preoperative operating room, at the 1st postoperative hour, on the 1st, 3rd, 5th postoperative days.
Secondary outcomes (1)
Mini-cog test
Mini-cog test will be applied to female patients who will undergo breast cancer surgery at the 24th hour before surgery, before and after surgery, and on the 1st, 3rd and 5th days after surgery. In this test, the patient's neurocognitive status will be evaluated by asking simple questions investigating their mental characteristics. Each question has a score and the total score indicates the patient's condition. In these patients, this test will be repeated at regular intervals during and after surgery and the results will be recorded. High scores on this test indicate good neurological stability, whereas falling is associated with poor neurological status.Changed in value as a result of this test will be investigated.
Measured: Preoperative 24 hours before, in the preoperative operating room, at the 1st postoperative hour, on the 1st, 3rd, 5th postoperative days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start12 Nov 2024
- Primary completion15 Feb 2025 (estimated)
- Study completion15 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neurocognitive DisorderStudies 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
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Haseki Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Munevver Duzgun, Haseki Training and Research Hospital
- Investigators
- Oznur Sen, Associate Professor, Study director, Haseki Training and Research HospitalMunevver Kayhan, Medical Doctor, Study chair, Haseki Training and Research HospitalEsra Kahya Tepe, Medical Resident Doctor, Principal investigator, Haseki Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06685770
- Sponsor's protocol ID
- HEA-AAR-EK-01
- Status last verified
- Nov 2024
- First submitted
- 11 Nov 2024
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jo YY, Kim JY, Lee JY, Choi CH, Chang YJ, Kwak HJ. The effect of intraoperative dexmedetomidine on acute kidney injury after pediatric congenital heart surgery: A prospective randomized trial. Medicine (Baltimore). 2017 Jul;96(28):e7480. doi: 10.1097/MD.0000000000007480.
PubMed 28700489Bocskai T, Kovacs M, Szakacs Z, Gede N, Hegyi P, Varga G, Pap I, Toth I, Revesz P, Szanyi I, Nemeth A, Gerlinger I, Karadi K, Lujber L. Is the bispectral index monitoring protective against postoperative cognitive decline? A systematic review with meta-analysis. PLoS One. 2020 Feb 13;15(2):e0229018. doi: 10.1371/journal.pone.0229018. eCollection 2020.
PubMed 32053678
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF PEROPERATIVE TOTAL INTRAVENOUS ANESTHESIA AND INHALER ANESTHESIA ON POSTOPERATIVE NEUROCGNITIVE DISORDER IN BREAST CANCER SURGERY
- ClinicalTrials.gov ID
- NCT06685770
- Acronym / sponsor ID
- HEA-AAR-EK-01
- Conditions
- Neurocognitive Disorder, General Anesthesia, Total Intravenous Anesthesia, Sevoflurane Anaesthesia, Breast Surgery
- Keywords
- neurocognitive disorder, general anesthesia, mini mental state assessment, mini-cog test
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Haseki Training and Research HospitalUniversity, hospital or other
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- 15 Feb 2025 (estimated)
- Study completion
- 15 May 2025 (estimated)
- First posted
- 12 Nov 2024 (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 prospective study, the effects of different anesthesia methods (total intravenous anesthesia and inhaled anesthesia) on neurocognitive function will be examined in patients undergoing breast-conserving surgery without axillary lymph node dissection. Mini-Mental State Examination and Mini-Cog tests will be administered at specific intervals pre and postoperatively. Anesthesia management will follow standard protocols, and the researcher will not intervent in these processes. The relationship between the type of anesthesia and neurocognitive outcomes will be evaluated based on the collected data.
Detailed description
During the preoperative evaluation process, after identifying patients with breast cancer who will undergo breast-conserving surgery and who will not undergo axillary lymph dissection, who meet the inclusion criteria in the study, neurocognitive evaluations of these patients will be performed by the anesthesiologist with the mini-mental state assessment (MMDD) test and Mini-cog test 24 hours before the preoperative period. These two tests will be repeated by the same doctor in the preoperative waiting room on the day of the operation.
From the preoperative waiting room, patients will be taken to the operation room after premedication with 2mg intravenous midazolam. After all patients are monitored with standard American Society of Anesthesia monitoring (heart rate, peripheral saturation, noninvasive artery monitoring) and electro encephalography monitoring (patient state index (PSI)), the initial values will be recorded before surgery. During induction, 1-2mg/kg propofol, 2mcg/kg Fentanyl and 0.8mg/kg rocuronium will be administered and then the patient will be intubated. Patients will be monitored to be normothermic by body temperature monitoring. If peroperative heart rate and noninvasive arterial pressure values increase by more than 20% of the presurgical basal value, remifentanil will be administered as an intravenous infusion between 0.05-2mcg/kg/min to all patients. During the peroperative period, noninvasive arterial pressure values, saturation values, heart rate, Patient state index values, Suppression rates and times, body temperature values will be recorded on the follow up form as values before the operation, at the beginning of the operation, at 30minute intervals from the beginning of the operation, and before and after extubation at the end of the operation. During surgery, peroperative anesthesia management will be determined as the ideal anesthesia method for the patient, as deemed appropriate by the relevant anesthesiologist, and there will be no intervention by the anesthesiologist performing the neurocognitive evaluation.
Heart Rate, saturation, noninvasive arterial pressure values will be recorded upon entry and exit from the postoperative recovery unit. Postoperative pain monitoring will be done with Visual analog scala(VAS), and to patients with a Visual analog scala value above 3, Tramadol 100mg every 6 hours, Nonsteroidal anti-inflammatory 100mg every 6 hours, and paracetamol 1000mg every 6 hours will be given intravenously if necessary. MMDD test and Mini-cog test will be repeated in all patients by the anesthesiologist just before being transferred from the postoperative recovery unit to the ward and at the 24th hour, 3rd day, and 5th day postoperatively.
After all neurocognitive evaluations of the patients are performed at planned intervals for 1 week, which anesthesia method was applied to the patients in the peroperative period will be determined from the anesthesia follow-up sheet and the total time and amount used will be recorded. Patients who underwent total intravenous anesthesia and inhaler anesthesia will be included in the study. Patients whose anesthesia management is changed during the case will be considered excluded from the study. Anesthesia management of patients during the preoperative and peroperative periods will be planned and implemented as deemed appropriate by the anesthesiologist who follows the patient during the surgery, regardless of this planned study. The researcher performing the neurocognitive evaluation will not have any intervention or knowledge in these processes. The reason why this study was planned as a prospective study is that neurocognitive evaluations are performed prospectively. There will be no intervention in the patient's preoperative, peroperative and postoperative anesthesia management.
At the end of the study, the relationship between neurocognitive values and total intravenous anesthesia and inhaled anesthetics will be compared.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| total intravenous anesthesia groups | – | Other: Mini mental state assessment test, Other: Mini-cog testIn this study, neurological evaluation tests will be performed before and after surgery for patients who will undergo surgery for breast cancer. All patients will be followed during the perioperative period according to the standards specified in the American Society of Anesthesia guideline. Neurological evaluations will be performed at the 24th hour before surgery, on the day of surgery, and on the 1st, 3rd and 5th days after surgery. Those who underwent total intravenous anesthesia after peroperative anesthesia management will constitute this group. The total amounts of propofol and remifentanil consumed in this group will be recorded. |
| inhaled anesthesia groups | – | Other: Mini mental state assessment test, Other: Mini-cog testIn this study, neurological evaluation tests will be performed before and after surgery for patients who will undergo surgery for breast cancer. All patients will be followed during the perioperative period according to the standards specified in the American Society of Anesthesia guideline. Neurological evaluations will be performed at the 24th hour before surgery, on the day of surgery, and on the 1st, 3rd and 5th days after surgery. Those who received inhaler anesthesia after peroperative anesthesia management will constitute this group. In this group, Minimal alveolar concentration levels of sevoflurane and total amounts of remifentanil will be recorded. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients who applied to the general surgery clinic of Haseki Training and Research Hospital due to the diagnosis of early stage breast cancer (stage 1-2) and planned breast-conserving surgery (mass removal only) will be included in this study. Since the neurocognitive status assessment will be made precisely in these patients, diseases and factors affecting the neurological status will be recorded as non-study factors and these patients will be excluded from the study. Preoperative anxiety scores, comorbidities and regular medications of the patients included in the study will also be recorded.
Key inclusion criteria (1 listed)
- Female patients with early stage breast cancer who will undergo breast-conserving surgery
Key exclusion criteria (22 listed)
- Patients receiving neoadjuvant radiotherapy and chemotherapy
- Patients who will undergo axillary lymph dissection and total mastectomy
- Asa 4-5 patients
- Patients without voluntary consent
- Patients with previous surgery or vertebrobasilar insufficiency
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 |
|---|---|---|
| Mini mental state assessment testAlso: neurocognitive assessment testBreast cancer is a very common and important disease in the female population around the world. Anesthesia management during surgery for this disease in the postoperative period should be carefully planned. It will be important to examine the neurocognitive effects of anesthesia management in the postoperative period in this patient group. Today, inhaler and total intravenous anesthesia have advantages as well as disadvantages. It would be valuable to examine its neurocognitive effects in this patient group. In this study, the frequently used Mini mental state assessment test and Mini-cog test will be used.With mini mental state assessment, the patient is asked a number of simple questions to evaluate cognitive functions and each question has certain points. Changes in these score levels preoperatively and postoperatively will be compared within each patient. At the end of the study, preoperative and postoperative changes will be compared statistically between the groups. | Other | inhaled anesthesia groups, total intravenous anesthesia groups |
| Mini-cog testAlso: neurocognitive assessment testBreast cancer is a very common and important disease in the female population around the world. Anesthesia management during surgery for this disease in the postoperative period should be carefully planned. It will be important to examine the neurocognitive effects of anesthesia management in the postoperative period in this patient group. Today, inhaler and total intravenous anesthesia have advantages as well as disadvantages. It would be valuable to examine its neurocognitive effects in this patient group. In this study, the frequently used Mini-cog test will be used.With Mini-cog test, the patient is asked a number of simple questions to evaluate cognitive functions and each question has certain points. Changes in these score levels preoperatively and postoperatively will be compared within each patient. At the end of the study, preoperative and postoperative changes will be compared statistically between the groups. | Other | inhaled anesthesia groups, total intravenous anesthesia groups |
Primary outcome
Decrease in Mini Mental State Assessment test
Time frame: Preoperative 24 hours before, in the preoperative operating room, at the 1st postoperative hour, on the 1st, 3rd, 5th postoperative days.
Female patients who will undergo breast cancer surgery will be given a mini mental state assessment test at the preoperative 24th hour, before and after surgery, and on the 1st, 3rd, and 5th postoperative days. In this test, the patient's neurocognitive status will be evaluated by asking simple questions that investigate their mental characteristics. Each question has a score and the total score indicates the patient's condition. In these patients, this test will be repeated at regular intervals after surgery and postoperatively and the results will be recorded.High scores on this test indicate good neurological stability, whereas falling is associated with poor neurological status. Changed in the value as a result of this test will be investigated.
1 secondary outcome
Mini-cog test
Time frame: Preoperative 24 hours before, in the preoperative operating room, at the 1st postoperative hour, on the 1st, 3rd, 5th postoperative days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Background: PubMed 28700489Jo YY, Kim JY, Lee JY, Choi CH, Chang YJ, Kwak HJ. The effect of intraoperative dexmedetomidine on acute kidney injury after pediatric congenital heart surgery: A prospective randomized trial. Medicine (Baltimore). 2017 Jul;96(28):e7480. doi: 10.1097/MD.0000000000007480.
- Background: PubMed 32053678Bocskai T, Kovacs M, Szakacs Z, Gede N, Hegyi P, Varga G, Pap I, Toth I, Revesz P, Szanyi I, Nemeth A, Gerlinger I, Karadi K, Lujber L. Is the bispectral index monitoring protective against postoperative cognitive decline? A systematic review with meta-analysis. PLoS One. 2020 Feb 13;15(2):e0229018. doi: 10.1371/journal.pone.0229018. eCollection 2020.
- 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.
Oznur Sen, Associate Professor study director
Haseki Training and Research Hospital
Munevver Kayhan, Medical Doctor study chair
Haseki Training and Research Hospital
Esra Kahya Tepe, Medical Resident Doctor principal investigator
Haseki Training and Research 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 Neurocognitive Disorder and General Anesthesia, run by Haseki Training and Research Hospital 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 1 inclusion and 22 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: under way, not looking for participants, as of the sponsor's last update on 14 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
Decrease in Mini Mental State Assessment test (time frame: Preoperative 24 hours before, in the preoperative operating room, at the 1st postoperative hour, on the 1st, 3rd, 5th postoperative days.). 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 NCT06685770, which also lists 2 linked publications.
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 14 Nov 2024.