Ignite Creation Date:
2024-05-06 @ 7:30 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06036498
Status:
RECRUITING
Last Update Posted:
2023-09-14
First Post:
2023-08-30
Brief Title:
Evaluation of Cerebral Blood Flow and Cerebral Oxygenation With Transcranial Doppler and NIRS in Laparoscopic Cholecystectomy Cases
Sponsor:
Uludag University
Organization:
Uludag University
Study Overview
Official Title:
Evaluation of Cerebral Blood Flow and Cerebral Oxygenation With Transcranial Doppler and NIRS in Laparoscopic Cholecystectomy Cases
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NIRS LC
Brief 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
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
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 Hypercarbias 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
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 Hypercarbias 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None