Cerebral HypoperfusionNIRS L/CNCT06036498
Evaluation of Cerebral Blood Flow and Cerebral Oxygenation With Transcranial Doppler and NIRS in Laparoscopic Cholecystectomy Cases
An observational study of Cerebral Hypoperfusion and Cerebral Occlusion, run by Uludag University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to test intracranial blood flow and cerebral oxygenisation changes in patients who have pneumoperitoneum in laparoscopic cholecystectomy procedure. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Hypoperfusion, Cerebral Occlusion, Cholecystitis; Gallstone
- What is being tested?
- Near Infrared Spectrophotometry Device, Transcranial Doppler Ultrasonography
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Jan 2023to 26 Jun 2024
- How long will I take part?
- 1 Day
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who has; * Cholelithiasis, * Gallbladder Stones, * Diagnosed with acute cholecystitis
Who may be able to join
- Patients with American Society of Anesthesiology (ASA) 1-3 classification,
- Both male and female patients between the ages of 18 to 65,
- Patients scheduled for elective laparoscopic cholecystectomy.
Who cannot join
- American Society of Anesthesiology (ASA) 4 and above patient groups,
- Patients aged under 18 and over 65,
- Patients with a history of known previous cerebrovascular accident (CVA),
- Patients with follow-up due to Cerebrovascular Ischemic Brain Attack Syndrome (CIBAS),
- Patients diagnosed with Carotid Stenosis,
- Patients diagnosed with peripheral and central vascular diseases,
- Patients with general debilitation and extreme senility,
- Cases that require conversion to laparotomy during the intraoperative period.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bursa Uludag University, Faculty of Medicine, Department of Anesthesiology and Reanimation
Bursa, Nilufer, 16285
Kadir Bugra Basaran, M.D., +905422780016, kbugrabasaran@gmail.com
About this study
The goal of this clinical trial is to test intracranial blood flow and cerebral oxygenisation changes in patients who have pneumoperitoneum in laparoscopic cholecystectomy procedure.
The main questions aim to answer are:
- How does pneumoperitoneum in laparoscopic cholecystectomy procedure changes blod flow in patients?
- Are there any differences between Near-Red spectroscopy and transcranial doppler ultrasonography assesment?
Participants will be diagnosed with using NIRS probes and Doppler ultrasonography probes if any changes in surgical procedure.
Researchers will compare NIRS and TCD detection outcomes to see if there is any differences.
Read the detailed description
Laparoscopic cholecystectomy is the gold standard treatment method for benign gallbladder stones. The required pneumoperitoneum for the operation leads to hemodynamic and metabolic changes in patients. Prolonged complicated laparoscopic surgeries also pose an additional risk factor for neurological complications.
Cerebral circulation occurs within a closed environment enclosed by the skull. This environment includes brain tissue, blood volume, and cerebrospinal fluid. Cerebral blood pressure arises from the difference between arterial blood pressure and intracranial pressure. Due to carbondioxide insufflation in laparoscopic surgery, caused by pneumoperitoneum creation, intra-abdominal carbondioxide is rapidly absorbed through the peritoneal membrane and enters the bloodstream.
Carbonic acid formed by the carbonic anhydrase enzyme in the plasma leads to respiratory acidosis. The resulting respiratory acidosis triggers peripheral and central vasodilation to ensure oxygenation and gas exchange, causing a rightward shift in the hemoglobin curve. Hypercarbia's impact on cells and the effect of cellular acidosis lead to local tissue edema. All of these factors contribute to changes in transcranial pressure. An increase in intracranial pressure can result in impaired cerebral perfusion.
Transcranial Doppler (TCD) is a reliable tool for imaging intracranial pressure due to its affordability, non-invasiveness, repeatability at the bedside, and real-time data provision during acute situations. Transcranial Doppler ultrasonography (TCD) can better display flow velocity waveforms, flow direction, intraparenchymal flow velocity, and density compared to other diagnostic tests. Changes in waveforms detected by TCD allow tracking changes in intracranial pressure. However, assessing tissue oxygenation solely with transcranial Doppler ultrasonography is not feasible.
Near-Infrared Spectroscopy (NIRS) can play an effective role in showing tissue oxygen perfusion for this purpose. NIRS imaging, similar to pulse oximetry, utilizes infrared light between 650 and 1000 nm to measure oxyhemoglobin levels in tissues and capillaries. Its non-invasiveness, ease of tolerance by the patient, and ability to quickly detect sudden drops in oxygen levels in tissues make it reliable.
In this study, Researchers aimed at implementing in patients planned for laparoscopic cholecystectomy, intend to use TCD and NIRS protocols to detect changes in intracranial blood flow and cerebral tissue oxygenation during the preoperative, intraoperative, and postoperative periods.
- Conditions
- Cerebral Hypoperfusion, Cerebral Occlusion, Cholecystitis; Gallstone, Cholecystitis/Cholelithiasis
- Being tested
- Near Infrared Spectrophotometry Device, Transcranial Doppler Ultrasonography
- Keywords
- Near Infra-Red Spectrophotometry, Cerebral Oxygenisation, Transcranial Doppler Ultrasonography (TCD), Laparoscopic Surgery
- Medical subject headings
- Cerebrovascular Disorders, Cholecystitis, Gallstones, Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near Infrared Spectrophotometry Device, Transcranial Doppler UltrasonographyDevice
Also called NIRS, iNVOS Spectrophotometry
We will get signals from the NIRS probes which are positioned bitemporal region of forehead in same time testing intracranial blood flow via TCD device.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative Assessment of Trail Group | Not described Receives: Device: Near Infrared Spectrophotometry Device, Transcranial Doppler Ultrasonography | |
| Post-Anaesthetic Induction Assessment of Trial Groups | Not described Receives: Device: Near Infrared Spectrophotometry Device, Transcranial Doppler Ultrasonography | |
| After Pneumoperitoneum Assessment of Trial Groups | Not described Receives: Device: Near Infrared Spectrophotometry Device, Transcranial Doppler Ultrasonography | |
| Within Head-up Tilt Position Assessment of Trial Groups | Not described Receives: Device: Near Infrared Spectrophotometry Device, Transcranial Doppler Ultrasonography | |
| Neuralized Position Assessment of Trial Groups | Not described Receives: Device: Near Infrared Spectrophotometry Device, Transcranial Doppler Ultrasonography | |
| Within Deflation of Abdomen Assessment of Trial Groups | Not described Receives: Device: Near Infrared Spectrophotometry Device, Transcranial Doppler Ultrasonography | |
| Awaking Period from Anaesthesia Assessment of Trial Groups | Not described Receives: Device: Near Infrared Spectrophotometry Device, Transcranial Doppler Ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detecting Cerebral Blood Flow Changes at Pneumoperitoneum Time via New Assessment Methods
In this study, aimed at patients scheduled for laparoscopic cholecystectomy, Researchers intend to utilize transcranial doppler ultrasonography to detect changes in intracranial blood flow changes during the preoperative, intraoperative, and postoperative periods.
Measured: Perioperative Time in Laparoscopic Cholecystectomy Surgery Procedures
Detecting Cerebral Tissue Oxygenisation Changes at Pneumoperitoneum Time via New Assessment Methods
In this study, aimed at patients scheduled for laparoscopic cholecystectomy, Researchers intend to utilize Near Infrared spectrophotometry methods to detect oxygenisation changes in cerebral hemispheres during the preoperative, intraoperative, and postoperative periods.
Measured: Perioperative Time in Laparoscopic Cholecystectomy Surgery Procedures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start18 Jan 2023
- Primary completion1 Jun 2024 (estimated)
- Study completion26 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral HypoperfusionStudies 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
- 40 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kadir Bugra Basaran, Uludag University
- Investigators
- Kadir Bugra Basaran, Study chair, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06036498
- Sponsor's protocol ID
- Bursa Uludag Universitesi
- Acronym
- NIRS L/C
- Status last verified
- Sep 2023
- First submitted
- 30 Aug 2023
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cerebral Blood Flow and Cerebral Oxygenation With Transcranial Doppler and NIRS in Laparoscopic Cholecystectomy Cases
- ClinicalTrials.gov ID
- NCT06036498
- Acronym / sponsor ID
- NIRS L/C / Bursa Uludag Universitesi
- Conditions
- Cerebral Hypoperfusion, Cerebral Occlusion, Cholecystitis; Gallstone, Cholecystitis/Cholelithiasis
- Keywords
- Near Infra-Red Spectrophotometry, Cerebral Oxygenisation, Transcranial Doppler Ultrasonography (TCD), Laparoscopic Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 18 Jan 2023 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 26 Jun 2024 (estimated)
- First posted
- 14 Sep 2023 (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 goal of this clinical trial is to test intracranial blood flow and cerebral oxygenisation changes in patients who have pneumoperitoneum in laparoscopic cholecystectomy procedure.
The main questions aim to answer are:
- How does pneumoperitoneum in laparoscopic cholecystectomy procedure changes blod flow in patients?
- Are there any differences between Near-Red spectroscopy and transcranial doppler ultrasonography assesment?
Participants will be diagnosed with using NIRS probes and Doppler ultrasonography probes if any changes in surgical procedure.
Researchers will compare NIRS and TCD detection outcomes to see if there is any differences.
Detailed description
Laparoscopic cholecystectomy is the gold standard treatment method for benign gallbladder stones. The required pneumoperitoneum for the operation leads to hemodynamic and metabolic changes in patients. Prolonged complicated laparoscopic surgeries also pose an additional risk factor for neurological complications.
Cerebral circulation occurs within a closed environment enclosed by the skull. This environment includes brain tissue, blood volume, and cerebrospinal fluid. Cerebral blood pressure arises from the difference between arterial blood pressure and intracranial pressure. Due to carbondioxide insufflation in laparoscopic surgery, caused by pneumoperitoneum creation, intra-abdominal carbondioxide is rapidly absorbed through the peritoneal membrane and enters the bloodstream.
Carbonic acid formed by the carbonic anhydrase enzyme in the plasma leads to respiratory acidosis. The resulting respiratory acidosis triggers peripheral and central vasodilation to ensure oxygenation and gas exchange, causing a rightward shift in the hemoglobin curve. Hypercarbia's impact on cells and the effect of cellular acidosis lead to local tissue edema. All of these factors contribute to changes in transcranial pressure. An increase in intracranial pressure can result in impaired cerebral perfusion.
Transcranial Doppler (TCD) is a reliable tool for imaging intracranial pressure due to its affordability, non-invasiveness, repeatability at the bedside, and real-time data provision during acute situations. Transcranial Doppler ultrasonography (TCD) can better display flow velocity waveforms, flow direction, intraparenchymal flow velocity, and density compared to other diagnostic tests. Changes in waveforms detected by TCD allow tracking changes in intracranial pressure. However, assessing tissue oxygenation solely with transcranial Doppler ultrasonography is not feasible.
Near-Infrared Spectroscopy (NIRS) can play an effective role in showing tissue oxygen perfusion for this purpose. NIRS imaging, similar to pulse oximetry, utilizes infrared light between 650 and 1000 nm to measure oxyhemoglobin levels in tissues and capillaries. Its non-invasiveness, ease of tolerance by the patient, and ability to quickly detect sudden drops in oxygen levels in tissues make it reliable.
In this study, Researchers aimed at implementing in patients planned for laparoscopic cholecystectomy, intend to use TCD and NIRS protocols to detect changes in intracranial blood flow and cerebral tissue oxygenation during the preoperative, intraoperative, and postoperative periods.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Preoperative Assessment of Trail Group | – | Device: Near Infrared Spectrophotometry Device, Transcranial Doppler Ultrasonography |
| Post-Anaesthetic Induction Assessment of Trial Groups | – | Device: Near Infrared Spectrophotometry Device, Transcranial Doppler Ultrasonography |
| After Pneumoperitoneum Assessment of Trial Groups | – | Device: Near Infrared Spectrophotometry Device, Transcranial Doppler Ultrasonography |
| Within Head-up Tilt Position Assessment of Trial Groups | – | Device: Near Infrared Spectrophotometry Device, Transcranial Doppler Ultrasonography |
| Neuralized Position Assessment of Trial Groups | – | Device: Near Infrared Spectrophotometry Device, Transcranial Doppler Ultrasonography |
| Within Deflation of Abdomen Assessment of Trial Groups | – | Device: Near Infrared Spectrophotometry Device, Transcranial Doppler Ultrasonography |
| Awaking Period from Anaesthesia Assessment of Trial Groups | – | Device: Near Infrared Spectrophotometry Device, Transcranial Doppler Ultrasonography |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who has; * Cholelithiasis, * Gallbladder Stones, * Diagnosed with acute cholecystitis
Key inclusion criteria (3 listed)
- Patients with American Society of Anesthesiology (ASA) 1-3 classification,
- Both male and female patients between the ages of 18 to 65,
- Patients scheduled for elective laparoscopic cholecystectomy.
Key exclusion criteria (8 listed)
- American Society of Anesthesiology (ASA) 4 and above patient groups,
- Patients aged under 18 and over 65,
- Patients with a history of known previous cerebrovascular accident (CVA),
- Patients with follow-up due to Cerebrovascular Ischemic Brain Attack Syndrome (CIBAS),
- Patients diagnosed with Carotid Stenosis,
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 |
|---|---|---|
| Near Infrared Spectrophotometry Device, Transcranial Doppler UltrasonographyAlso: NIRS, iNVOS SpectrophotometryWe will get signals from the NIRS probes which are positioned bitemporal region of forehead in same time testing intracranial blood flow via TCD device. | Device | After Pneumoperitoneum Assessment of Trial Groups, Awaking Period from Anaesthesia Assessment of Trial Groups, Neuralized Position Assessment of Trial Groups, Post-Anaesthetic Induction Assessment of Trial Groups, Preoperative Assessment of Trail Group, Within Deflation of Abdomen Assessment of Trial Groups, Within Head-up Tilt Position Assessment of Trial Groups |
Primary outcome
Detecting Cerebral Blood Flow Changes at Pneumoperitoneum Time via New Assessment Methods
Time frame: Perioperative Time in Laparoscopic Cholecystectomy Surgery Procedures
In this study, aimed at patients scheduled for laparoscopic cholecystectomy, Researchers intend to utilize transcranial doppler ultrasonography to detect changes in intracranial blood flow changes during the preoperative, intraoperative, and postoperative periods.
Detecting Cerebral Tissue Oxygenisation Changes at Pneumoperitoneum Time via New Assessment Methods
Time frame: Perioperative Time in Laparoscopic Cholecystectomy Surgery Procedures
In this study, aimed at patients scheduled for laparoscopic cholecystectomy, Researchers intend to utilize Near Infrared spectrophotometry methods to detect oxygenisation changes in cerebral hemispheres during the preoperative, intraoperative, and postoperative periods.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
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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.
Kadir Bugra Basaran study chair
Uludag 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 Cerebral Hypoperfusion and Cerebral Occlusion, run by Uludag University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 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 14 Sep 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 Kadir Bugra Basaran (+905422780016, kbugrabasaran@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detecting Cerebral Blood Flow Changes at Pneumoperitoneum Time via New Assessment Methods (time frame: Perioperative Time in Laparoscopic Cholecystectomy Surgery Procedures). The study lists 2 primary outcomes in all. 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 14 Sep 2023.