Ischemic Attack, TransientNCT04714346
Does Positioning Effects on Early Postoperative Cognitive Dysfunction in Laparoscopic Oncological Surgery
An observational study of Ischemic Attack, Transient, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Laparoscopic surgery is an alternative to open surgical techniques for reasons such as less blood loss,less need for transfusion, shorter discharge time. In laparoscopic cases, various positions are given to patients, especially trendelenburg, in order to remove organs and see the area of the operation more easily. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ischemic Attack, Transient
- How many people
- 53 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Aug 2019to 8 May 2020
- How long will I take part?
- 10 Months
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who do not meet the exclusion criteria will undergo laparoscopic major abdominal oncological surgery over the age of 18.
Who may be able to join
- 18 years and above,
- 24 points and above on MMSE test,
- Laparoscopic major abdominal oncological surgery planned patients who will receive general anesthesia
Who cannot join
- People with a history of cerebral ischemia or hemorrhage,
- Those with a history of neurodegenerative disease,
- Those with diagnosed carotid stenosis,
- Those with a score of 23 and below on the MMSE test,
- Those with a history of Carotid Endarterectomy,
- Patients who have undergone aneurysm surgery,
Show all 10Show fewer
- Those who are addicted to alcohol,
- Those with psychiatric illness,
- Those who have undergone cervical surgery,
- Those with a history of transient ischemic attacks,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
SBU. Ankara A.Y. Oncology Research and Training Hospital
Ankara, 06530
About this study
Official title: Effects of Trendelenburg Position and Pneumoperitonium on Cerebral Tissue Oxygen Saturation and Early Postoperative Cognitive Dysfunction (POCD) in Patients Undergoing Laparoscopic Major Abdominal Oncological Surgery
Laparoscopic surgery is an alternative to open surgical techniques for reasons such as less blood loss,less need for transfusion, shorter discharge time. In laparoscopic cases, various positions are given to patients, especially trendelenburg, in order to remove organs and see the area of the operation more easily. The Trendelenburg position causes cerebrovascular changes.Several studies have reported an increase in intracranial pressure (ICP)at the Trendelenburg position. There are also studies that show brain tissue oxygen saturation (SctO2) decreases in this position. Research has reported that cerebral perfusion pressure decreases if the position lasts longer.When pneumoperitonium is administered during laparoscopic surgery, cerebral blood flow may increase as a result of the increase in PaCO2.Brain tissue oxygen saturation depends on blood flow.There is also an inverse ratio between end tidal CO2. To prevent deterioration of cerebral function, methods are needed that determine the onset of desaturation and make early intervention possible.
The method,known as near-infrared spectroscopy (NIRS), offers a fixed non-invasive and safe method of determining cerebral desaturation.In addition, NIRS has the potential to improve patient outcomes, reduce postoperative complications and duration of post-anesthesia care.Changes in NIRS measurement values associated with position, especially today, are seen in cerebral perfusion in patients undergoing major surgery, oxygenation and postop have been associated with cognitive dysfunction in the process.Postoperative cognitive dysfunction is associated with increased mortality and therefore it is very important to identify factors that increase risk in order to take appropriate protective measures.Intracerebral ischemia and desaturation may be responsible for the development of POCD.
In this study, we aimed to observe NIRS changes due to Trendelenburg position and pneumoperitonium in patients undergoing laparoscopic major abdominal oncological surgery and to examine the effect of POCD on early stage.
Read the detailed description
In Saglık Bilimleri University, Ankara A.Y. Oncology Research and Trainnee Hospital, Anesthesiology and reanimation clinic,patients who are scheduled for elective laparoscopic major abdominal surgery after the approval of the Ethics Committee will be enrolled in the study. From the beginning of the study, successive patients were included in the study. Measurement values were taken and recorded using the NIRS device in our clinic throughout the case in patients 18 years of age and older. All patients were evaluated with MMSE in preoperative and postoperative period. According to power analysis using mean and standard deviation to determine the sample size of the patients to be taken in this process, at least 52 patients were planned to be included in the study.
After preoperative MMSE testing, ASA scores, comorbidities,demographic data, drugs used in anesthesia, vasopressor use, pneumoperitonium pressures and duration, angle and duration of trendelenburg position, and vital parameters were recorded with NIRS device in our clinic.
MMSE test was re-administered to all patients in the first week of postoperative period.
Patients with preoperative MMSE score (M0) 24/30 points and above; postoperative 7th day (M1) was re-evaluated and those with a fall of 4 points and more in M1 score than M0 score were assessed as POCD.
NIRS measurements were taken perioperative and their correlation with POCD was looked at.
Inclusion criteria;
- 18 years and older,
- preoperative 24 points and above on MMSE test(M0)
- Laparoscopic major abdominal oncological surgery planned patients who will receive general anesthesia.
Exclusion criteria;
- People with a history of cerebral ischemia or hemorrhage,
- Those with a history of neurodegenerative disease,
- Those with diagnosed carotid stenosis,
- Those with a score of 23 and below on the MMSE test,
- Those with a history of Carotid Endarterectomy,
- Patients who have undergone aneurysm surgery,
- Those who are addicted to alcohol,
- Those with psychiatric illness,
- Those who have undergone cervical surgery,
- Those with a history of transient ischemic attacks,
- Conditions
- Ischemic Attack, Transient
- Being tested
- no interventions
- Keywords
- POCD, Trendelenburg position, pneumoperitonium, NIRS, MMSE
- Medical subject headings
- Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionsOther
there is no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
MMSE changings in POCD
Lowest MMSE score is 0;highest is 30. 24 is the limit of mild cognitive decline. In MMSE, to evaluate cognitive changings 4 point of decline is meaningful. Primarily, In our study, First patients with preoperative MMSE score(M0) 24/30 points and above will be re-evaluated on postoperative seventh day(M1) and those with a decrease of 4 points and greater than M0 score in M1 score will be evaluated as POCD.
Measured: each patient in seven days
Secondary outcomes (1)
NIRS measurement correlation
NIRS value of rSO2 changings was looked at. Rate of %20 and above were recorded as meaningful.
Secondarily, NIRS measurements will be taken perioperative and their correlation with POCD will be looked at.
Measured: each patient in seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start8 Aug 2019
- Primary completion8 May 2020
- Study completion8 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic Attack, TransientStudies 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
- 53 participants (actual)
- Target duration
- 10 Months
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hazal ozkaya hız, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04714346
- Sponsor's protocol ID
- 2019-08/384
- Status last verified
- Jan 2021
- First submitted
- 15 Jan 2021
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ozkaya Hiz H, Kalayci D, Altinel S, Unver S, Sen O. Association between intraoperative cerebral desaturation detected by near-infrared spectroscopy and early postoperative cognitive changes in patients undergoing laparoscopic major oncologic surgery: a preliminary exploratory study. BMC Surg. 2026 Jun 4. doi: 10.1186/s12893-026-03893-1. Online ahead of print.
PubMed 42237127
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Trendelenburg Position and Pneumoperitonium on Cerebral Tissue Oxygen Saturation and Early Postoperative Cognitive Dysfunction (POCD) in Patients Undergoing Laparoscopic Major Abdominal Oncological Surgery
- ClinicalTrials.gov ID
- NCT04714346
- Acronym / sponsor ID
- 2019-08/384
- Conditions
- Ischemic Attack, Transient
- Keywords
- POCD, Trendelenburg position, pneumoperitonium, NIRS, MMSE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 8 Aug 2019 (actual)
- Primary completion
- 8 May 2020 (actual)
- Study completion
- 8 May 2020 (actual)
- First posted
- 19 Jan 2021 (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.
Laparoscopic surgery is an alternative to open surgical techniques for reasons such as less blood loss,less need for transfusion, shorter discharge time. In laparoscopic cases, various positions are given to patients, especially trendelenburg, in order to remove organs and see the area of the operation more easily. The Trendelenburg position causes cerebrovascular changes.Several studies have reported an increase in intracranial pressure (ICP)at the Trendelenburg position. There are also studies that show brain tissue oxygen saturation (SctO2) decreases in this position. Research has reported that cerebral perfusion pressure decreases if the position lasts longer.When pneumoperitonium is administered during laparoscopic surgery, cerebral blood flow may increase as a result of the increase in PaCO2.Brain tissue oxygen saturation depends on blood flow.There is also an inverse ratio between end tidal CO2. To prevent deterioration of cerebral function, methods are needed that determine the onset of desaturation and make early intervention possible.
The method,known as near-infrared spectroscopy (NIRS), offers a fixed non-invasive and safe method of determining cerebral desaturation.In addition, NIRS has the potential to improve patient outcomes, reduce postoperative complications and duration of post-anesthesia care.Changes in NIRS measurement values associated with position, especially today, are seen in cerebral perfusion in patients undergoing major surgery, oxygenation and postop have been associated with cognitive dysfunction in the process.Postoperative cognitive dysfunction is associated with increased mortality and therefore it is very important to identify factors that increase risk in order to take appropriate protective measures.Intracerebral ischemia and desaturation may be responsible for the development of POCD.
In this study, we aimed to observe NIRS changes due to Trendelenburg position and pneumoperitonium in patients undergoing laparoscopic major abdominal oncological surgery and to examine the effect of POCD on early stage.
Detailed description
In Saglık Bilimleri University, Ankara A.Y. Oncology Research and Trainnee Hospital, Anesthesiology and reanimation clinic,patients who are scheduled for elective laparoscopic major abdominal surgery after the approval of the Ethics Committee will be enrolled in the study. From the beginning of the study, successive patients were included in the study. Measurement values were taken and recorded using the NIRS device in our clinic throughout the case in patients 18 years of age and older. All patients were evaluated with MMSE in preoperative and postoperative period. According to power analysis using mean and standard deviation to determine the sample size of the patients to be taken in this process, at least 52 patients were planned to be included in the study.
After preoperative MMSE testing, ASA scores, comorbidities,demographic data, drugs used in anesthesia, vasopressor use, pneumoperitonium pressures and duration, angle and duration of trendelenburg position, and vital parameters were recorded with NIRS device in our clinic.
MMSE test was re-administered to all patients in the first week of postoperative period.
Patients with preoperative MMSE score (M0) 24/30 points and above; postoperative 7th day (M1) was re-evaluated and those with a fall of 4 points and more in M1 score than M0 score were assessed as POCD.
NIRS measurements were taken perioperative and their correlation with POCD was looked at.
Inclusion criteria;
- 18 years and older,
- preoperative 24 points and above on MMSE test(M0)
- Laparoscopic major abdominal oncological surgery planned patients who will receive general anesthesia.
Exclusion criteria;
- People with a history of cerebral ischemia or hemorrhage,
- Those with a history of neurodegenerative disease,
- Those with diagnosed carotid stenosis,
- Those with a score of 23 and below on the MMSE test,
- Those with a history of Carotid Endarterectomy,
- Patients who have undergone aneurysm surgery,
- Those who are addicted to alcohol,
- Those with psychiatric illness,
- Those who have undergone cervical surgery,
- Those with a history of transient ischemic attacks,
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 10 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who do not meet the exclusion criteria will undergo laparoscopic major abdominal oncological surgery over the age of 18.
Key inclusion criteria (3 listed)
- 18 years and above,
- 24 points and above on MMSE test,
- Laparoscopic major abdominal oncological surgery planned patients who will receive general anesthesia
Key exclusion criteria (10 listed)
- People with a history of cerebral ischemia or hemorrhage,
- Those with a history of neurodegenerative disease,
- Those with diagnosed carotid stenosis,
- Those with a score of 23 and below on the MMSE test,
- Those with a history of Carotid Endarterectomy,
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 |
|---|---|---|
| no interventionsthere is no intervention | Other | – |
Primary outcome
MMSE changings in POCD
Time frame: each patient in seven days
Lowest MMSE score is 0;highest is 30. 24 is the limit of mild cognitive decline. In MMSE, to evaluate cognitive changings 4 point of decline is meaningful. Primarily, In our study, First patients with preoperative MMSE score(M0) 24/30 points and above will be re-evaluated on postoperative seventh day(M1) and those with a decrease of 4 points and greater than M0 score in M1 score will be evaluated as POCD.
1 secondary outcome
NIRS measurement correlation
Time frame: each patient in seven days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Derived from this study: PubMed 42237127Ozkaya Hiz H, Kalayci D, Altinel S, Unver S, Sen O. Association between intraoperative cerebral desaturation detected by near-infrared spectroscopy and early postoperative cognitive changes in patients undergoing laparoscopic major oncologic surgery: a preliminary exploratory study. BMC Surg. 2026 Jun 4. doi: 10.1186/s12893-026-03893-1. Online ahead of print.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ischemic Attack, Transient, run by Saglik Bilimleri Universitesi 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 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MMSE changings in POCD (time frame: each patient in seven 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 NCT04714346, which also lists 1 linked publication.
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 Jan 2021.