An observational study in Cerebral Hypoperfusion, Cerebral Occlusion and Cholecystitis; Gallstone, sponsored by Uludag University. Recruiting at 1 site in Turkey. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-14.
Sponsored by Uludag University · Observational
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:
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.
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.
449 studies on the registry are indexed under Cerebrovascular Disorders; 127 are open to participants now.
This study's planned enrollment of 40 is below the median of 450 across 145 observational studies indexed under Cerebrovascular Disorders.
Browse Cerebrovascular Disorders studies →Uludag University is the lead sponsor of 149 studies on the registry; 42 are open to participants now.
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Patients who has;
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Exclusion Criteria:
Device: Near Infrared Spectrophotometry Device, Transcranial Doppler Ultrasonography
Device: Near Infrared Spectrophotometry Device, Transcranial Doppler Ultrasonography
Device: Near Infrared Spectrophotometry Device, Transcranial Doppler Ultrasonography
Device: Near Infrared Spectrophotometry Device, Transcranial Doppler Ultrasonography
Device: Near Infrared Spectrophotometry Device, Transcranial Doppler Ultrasonography
Device: Near Infrared Spectrophotometry Device, Transcranial Doppler Ultrasonography
Device: Near Infrared Spectrophotometry Device, Transcranial Doppler Ultrasonography
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.
Also known as: NIRS, iNVOS Spectrophotometry
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.
Time frame: 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.
Time frame: Perioperative Time in Laparoscopic Cholecystectomy Surgery Procedures
Detecting any difference between Near Infrared Spectrophotomery and Transcranial Doppler
Researchers will compete Near Infrared spectrophotometry and transcranial doppler ultrasonography methods in cerebral hemodynamics in perioperative process in laparoscopic cholecystectomy patients.
Time frame: Perioperative Time in Laparoscopic Cholecystectomy Surgery Procedures
Started Jan 2023 (actual). Primary completion is estimated for Jun 2024, 16 months after the start.
Of 75 non-industry observational studies under Cerebrovascular Disorders, half reached primary completion within 103 months of starting (the median), counting those still running; a quarter within 59 and three quarters within 339. This study's planned 16 months is below that.
Counting every sponsor, half of 79 studies reached it within 103 months; a quarter within 46 and three quarters within 339.
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