Neurocognitive DisorderNCT06689137
Effects of Dexmedetomidine on Postoperative Neurocognitive Disorder
An observational study of Neurocognitive Disorder and Dexmedetomidine Infusion, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective study involves assessing neurocognitive function in patients undergoing laparotomic gastrointestinal surgery. Mini Mental state Assessment test and Mini-Cog tests will be conducted at multiple intervals preoperatively and postoperatively. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neurocognitive Disorder, Dexmedetomidine Infusion, Postoperative Cognitive Dysfunction
- 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
- 13 Oct 2024to 15 Jun 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who will undergo laparotomic lower and upper abdominal surgery will constitute the patient groups of this study. Patients who will be operated on due to early stage gastrointestinal tumor will constitute the study population. Among these patients, those without neurological disorders will be included in the study.
Who may be able to join
- Patients aged 18-65 who will undergo laparotomic lower and upper gastrointestinal system surgery
Who cannot join
- American society of anesthesia of 4-5 patients
- Patients without voluntary consent
- Patients with previous surgery or vertebrobasilar insufficiency
- Patients with Carotis stenosis
- Patients with a visual analog scale above 4 in the postoperative recovery unit
- Patients whose cerebral oxygenation decreased by 15% from the beginning in cerebral oximetry monitoring during the perioperative period
Show all 20Show fewer
- 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: Evaluation of the Effect of Dexmedetomidine Infusion on Postoperative Neurocognitive Disorder in Patients Undergoing Laparotomic Abdominal Surgery
This prospective study involves assessing neurocognitive function in patients undergoing laparotomic gastrointestinal surgery. Mini Mental state Assessment test and Mini-Cog tests will be conducted at multiple intervals preoperatively and postoperatively. Anesthesia management, vital signs, drug consumption, and blood gas values will be recorded throughout the surgery. After all neurocognitive evaluations of the patients are performed at planned intervals for 1 week, the levels of dexmedetomidine and remifentanyl consumed by the patients in the peroperative period will be determined from the anesthesia follow-up sheet and the total duration and amount used will be recorded. At the end of the study, the relationship between neurocognitive values and dexmedetomidine will be compared.
Read the detailed description
All results of laparotomic gastrointestinal surgery that meet the inclusion criteria of the preoperative anesthesia evaluation process will be determined, and the neurocognitive evaluations, mini mental state assessment test and Mini-cog test will be delivered to all these patients by the anesthesiologist doctor 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 midazolam. After patients are monitored with standard American Society of Anesthesia monitoring (Heart rate (HR), peripheral saturation, non-invasive artery pressure monitoring), patient state index(PSI), the first 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, and Sevoflurane anesthesia will be maintained at 1 Minimal alveolar concentration level as inhalation anesthesia. Patient state index value will be kept between 40-60%. During the peroperative period, non-invasive arterial pressure values, saturation values, heart rate, body temperature values will be recorded on the follow-up form as preoperative, at the beginning of the operation, at 30-minute intervals from the beginning of the operation, and before and after extubation at the end of the operation. If the anesthesiologist starts remifentanyl and dexmedetomidine infusion to the patients during the surgery, when it started and at what dose will be noted on the anesthesia chart. The anesthesiologist performing the neurocognitive evaluation will not be aware of this. The decision whether to start these medications will depend on the relevant anesthesiologist's decision regarding the patient's specific anesthesia management, regardless of the study.
Heart rate, peripheral saturation, non-invasive artery pressure values will be recorded upon entering and exiting the postoperative recovery unit. The patients' total bleeding amount, amount and type of intravenous fluid administered, and blood gas values will be recorded throughout the surgery.
Postoperative pain monitoring will be done with the Numerical Pain Rating Scale, and in patients with an Numerical pain rating scale score greater than 4, Tramadol will be given 100mg every 6 hours, Nonsteroidal anti-inflammatory 100mg every 8 hours, and paracetamol 1000mg every 6 hours will be given intravenously if necessary.
Mini mental state assessment 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 postoperative day.
After all neurocognitive evaluations of the patients are performed at planned intervals for 1 week, the levels of dexmedetomidine and remifentanyl consumed by the patients in the peroperative period will be determined from the anesthesia follow-up sheet and the total duration and amount used will be recorded.
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 surgical period, 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 prospectively is that neurocognitive evaluation will be performed prospectively for 1 week. There is no intervention in the patient's anesthesia management and medications, or in the grouping of patients and their treatment. At the end of the study, the relationship between neurocognitive values and dexmedetomidine will be compared.
- Conditions
- Neurocognitive Disorder, Dexmedetomidine Infusion, Postoperative Cognitive Dysfunction, Postoperative Cognitive Dysfunction(POCD), Laparoscopic Abdominal Surgery
- Being tested
- mini mental state assessment test, mini-cog test
- Keywords
- postoperative cognitive dysfunction, peroperative dexmedetomidine infusion, neurocognitive disorder
- Medical subject headings
- Neurocognitive Disorders, Postoperative Cognitive Complications
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 disorder assessment
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. 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 disorder assessment
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. In this study, the frequently used Mini mental state assessment test and 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 |
|---|---|---|
| with dexmedetomidine group | In this study, neurological evaluation tests will be performed before and after surgery for patients who will undergo laparotomic lower and upper gastrointestinal system surgery. 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 dexmedetomidine, remifentanyl consumed in this group will be recorded. Receives: Other: mini mental state assessment test; Other: mini-cog test | |
| without dexmedetomidine group | In this study, pre- and postoperative neurological evaluation tests will be performed on patients who will undergo laparotomic lower and upper gastrointestinal system surgery. All patients will be monitored during the perioperative period according to the standards specified in the American Society of Anesthesiologists guide. Neurological evaluations will be performed 24 hours before surgery, on the day of surgery, and on the 1st, 3rd and 5th days after surgery. Those who did not receive dexmedetomidine infusion during peroperative anesthesia management will constitute this group. The total amounts of and remifentanyl consumed in this group 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
Patients who will undergo laparotomic lower and upper gastrointestinal system 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)
Decrease in Mini-cog Test
Mini-cog test will be applied to undergo laparotomic lower and upper gastrointestinal system 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 characterise 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 posted14 Nov 2024
- Study start13 Oct 2024
- Primary completion15 Mar 2025 (estimated)
- Study completion15 Jun 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
- Munevver Kayhan, Medical Doctor, Principal investigator, Haseki Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06689137
- Sponsor's protocol ID
- HEA-AAR-MK-02
- Status last verified
- Nov 2024
- First submitted
- 12 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
Tufanogullari B, White PF, Peixoto MP, Kianpour D, Lacour T, Griffin J, Skrivanek G, Macaluso A, Shah M, Provost DA. Dexmedetomidine infusion during laparoscopic bariatric surgery: the effect on recovery outcome variables. Anesth Analg. 2008 Jun;106(6):1741-8. doi: 10.1213/ane.0b013e318172c47c.
PubMed 18499604Maldonado JR, Wysong A, van der Starre PJ, Block T, Miller C, Reitz BA. Dexmedetomidine and the reduction of postoperative delirium after cardiac surgery. Psychosomatics. 2009 May-Jun;50(3):206-17. doi: 10.1176/appi.psy.50.3.206.
PubMed 19567759
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
- Evaluation of the Effect of Dexmedetomidine Infusion on Postoperative Neurocognitive Disorder in Patients Undergoing Laparotomic Abdominal Surgery
- ClinicalTrials.gov ID
- NCT06689137
- Acronym / sponsor ID
- HEA-AAR-MK-02
- Conditions
- Neurocognitive Disorder, Dexmedetomidine Infusion, Postoperative Cognitive Dysfunction, Postoperative Cognitive Dysfunction(POCD), Laparoscopic Abdominal Surgery
- Keywords
- postoperative cognitive dysfunction, peroperative dexmedetomidine infusion, neurocognitive disorder
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Haseki Training and Research HospitalUniversity, hospital or other
- Study start
- 13 Oct 2024 (actual)
- Primary completion
- 15 Mar 2025 (estimated)
- Study completion
- 15 Jun 2025 (estimated)
- First posted
- 14 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.
This prospective study involves assessing neurocognitive function in patients undergoing laparotomic gastrointestinal surgery. Mini Mental state Assessment test and Mini-Cog tests will be conducted at multiple intervals preoperatively and postoperatively. Anesthesia management, vital signs, drug consumption, and blood gas values will be recorded throughout the surgery. After all neurocognitive evaluations of the patients are performed at planned intervals for 1 week, the levels of dexmedetomidine and remifentanyl consumed by the patients in the peroperative period will be determined from the anesthesia follow-up sheet and the total duration and amount used will be recorded. At the end of the study, the relationship between neurocognitive values and dexmedetomidine will be compared.
Detailed description
All results of laparotomic gastrointestinal surgery that meet the inclusion criteria of the preoperative anesthesia evaluation process will be determined, and the neurocognitive evaluations, mini mental state assessment test and Mini-cog test will be delivered to all these patients by the anesthesiologist doctor 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 midazolam. After patients are monitored with standard American Society of Anesthesia monitoring (Heart rate (HR), peripheral saturation, non-invasive artery pressure monitoring), patient state index(PSI), the first 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, and Sevoflurane anesthesia will be maintained at 1 Minimal alveolar concentration level as inhalation anesthesia. Patient state index value will be kept between 40-60%. During the peroperative period, non-invasive arterial pressure values, saturation values, heart rate, body temperature values will be recorded on the follow-up form as preoperative, at the beginning of the operation, at 30-minute intervals from the beginning of the operation, and before and after extubation at the end of the operation. If the anesthesiologist starts remifentanyl and dexmedetomidine infusion to the patients during the surgery, when it started and at what dose will be noted on the anesthesia chart. The anesthesiologist performing the neurocognitive evaluation will not be aware of this. The decision whether to start these medications will depend on the relevant anesthesiologist's decision regarding the patient's specific anesthesia management, regardless of the study.
Heart rate, peripheral saturation, non-invasive artery pressure values will be recorded upon entering and exiting the postoperative recovery unit. The patients' total bleeding amount, amount and type of intravenous fluid administered, and blood gas values will be recorded throughout the surgery.
Postoperative pain monitoring will be done with the Numerical Pain Rating Scale, and in patients with an Numerical pain rating scale score greater than 4, Tramadol will be given 100mg every 6 hours, Nonsteroidal anti-inflammatory 100mg every 8 hours, and paracetamol 1000mg every 6 hours will be given intravenously if necessary.
Mini mental state assessment 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 postoperative day.
After all neurocognitive evaluations of the patients are performed at planned intervals for 1 week, the levels of dexmedetomidine and remifentanyl consumed by the patients in the peroperative period will be determined from the anesthesia follow-up sheet and the total duration and amount used will be recorded.
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 surgical period, 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 prospectively is that neurocognitive evaluation will be performed prospectively for 1 week. There is no intervention in the patient's anesthesia management and medications, or in the grouping of patients and their treatment. At the end of the study, the relationship between neurocognitive values and dexmedetomidine will be compared.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with dexmedetomidine group | – | 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 laparotomic lower and upper gastrointestinal system surgery. 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 dexmedetomidine, remifentanyl consumed in this group will be recorded. |
| without dexmedetomidine group | – | Other: mini mental state assessment test, Other: mini-cog testIn this study, pre- and postoperative neurological evaluation tests will be performed on patients who will undergo laparotomic lower and upper gastrointestinal system surgery. All patients will be monitored during the perioperative period according to the standards specified in the American Society of Anesthesiologists guide. Neurological evaluations will be performed 24 hours before surgery, on the day of surgery, and on the 1st, 3rd and 5th days after surgery. Those who did not receive dexmedetomidine infusion during peroperative anesthesia management will constitute this group. The total amounts of and remifentanyl consumed in this group will be recorded. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who will undergo laparotomic lower and upper abdominal surgery will constitute the patient groups of this study. Patients who will be operated on due to early stage gastrointestinal tumor will constitute the study population. Among these patients, those without neurological disorders will be included in the study.
Key inclusion criteria (1 listed)
- Patients aged 18-65 who will undergo laparotomic lower and upper gastrointestinal system surgery
Key exclusion criteria (20 listed)
- American society of anesthesia of 4-5 patients
- Patients without voluntary consent
- Patients with previous surgery or vertebrobasilar insufficiency
- Patients with Carotis stenosis
- Patients with a visual analog scale above 4 in the postoperative recovery unit
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 disorder assessmentAnesthesia 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. 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 | with dexmedetomidine group, without dexmedetomidine group |
| mini-cog testAlso: neurocognitive disorder assessmentAnesthesia 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. In this study, the frequently used Mini mental state assessment test and 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 | with dexmedetomidine group, without dexmedetomidine group |
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.
Patients who will undergo laparotomic lower and upper gastrointestinal system 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
Decrease in 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 18499604Tufanogullari B, White PF, Peixoto MP, Kianpour D, Lacour T, Griffin J, Skrivanek G, Macaluso A, Shah M, Provost DA. Dexmedetomidine infusion during laparoscopic bariatric surgery: the effect on recovery outcome variables. Anesth Analg. 2008 Jun;106(6):1741-8. doi: 10.1213/ane.0b013e318172c47c.
- Background: PubMed 19567759Maldonado JR, Wysong A, van der Starre PJ, Block T, Miller C, Reitz BA. Dexmedetomidine and the reduction of postoperative delirium after cardiac surgery. Psychosomatics. 2009 May-Jun;50(3):206-17. doi: 10.1176/appi.psy.50.3.206.
- Individual participant dataSharing planned: No
Related trials for Neurocognitive Disorder
Not yet recruiting
Virtual Reality to Advance Dementia Care and Quality of Life
Dementia, Agitation
RecruitingPhase 2
Prevention/Reduction of ASRs and PTSD to Sustain Civilian Performance With Sublingual Cyclobenzaprine HCl (TNX-102 SL)
Acute Stress Reaction, Acute Stress Disorder
Enrolling by invitation
Preventing Loss of Independence Through Exercise in Community Living Centers
Dementia, Cognitive Dysfunction
RecruitingPhase 2
Ca-Mg Butyrate in Gulf War Illness
Gulf War Illness, Chronic Fatigue
Not yet recruitingObservational study
Impact of Preoperative Mild Cognitive Impairment on Postoperative Delirium in Patients Undergoing Cardiac Surgery
Neurocognitive Disorder, Cardiac Surgery
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.
Munevver Kayhan, Medical 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 Dexmedetomidine Infusion, 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 20 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 NCT06689137, 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; AzTrials last refreshed its copy on 26 Oct 2026.