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Evaluation of Cerebral Blood Flow and Cerebral Oxygenation With Transcranial Doppler and NIRS in Laparoscopic Cholecystectomy Cases (NIRS L/C)

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ClinicalTrials.gov Identifier: NCT06036498
Recruitment Status : Recruiting
First Posted : September 14, 2023
Last Update Posted : September 14, 2023
Sponsor:
Information provided by (Responsible Party):
Kadir Bugra Basaran, Uludag University

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment
Cerebral Hypoperfusion Cerebral Occlusion Cholecystitis; Gallstone Cholecystitis/Cholelithiasis Device: Near Infrared Spectrophotometry Device, Transcranial Doppler Ultrasonography

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
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Evaluation of Cerebral Blood Flow and Cerebral Oxygenation With Transcranial Doppler and NIRS in Laparoscopic Cholecystectomy Cases
Actual Study Start Date : January 18, 2023
Estimated Primary Completion Date : June 1, 2024
Estimated Study Completion Date : June 26, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Preoperative Assessment of Trail Group 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.
Other Names:
  • NIRS
  • iNVOS Spectrophotometry
Post-Anaesthetic Induction Assessment of Trial Groups 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.
Other Names:
  • NIRS
  • iNVOS Spectrophotometry
After Pneumoperitoneum Assessment of Trial Groups 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.
Other Names:
  • NIRS
  • iNVOS Spectrophotometry
Within Head-up Tilt Position Assessment of Trial Groups 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.
Other Names:
  • NIRS
  • iNVOS Spectrophotometry
Neuralized Position Assessment of Trial Groups 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.
Other Names:
  • NIRS
  • iNVOS Spectrophotometry
Within Deflation of Abdomen Assessment of Trial Groups 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.
Other Names:
  • NIRS
  • iNVOS Spectrophotometry
Awaking Period from Anaesthesia Assessment of Trial Groups 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.
Other Names:
  • NIRS
  • iNVOS Spectrophotometry


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Other Outcome Measures:
  1. Detecting any difference between Near Infrared Spectrophotomery and Transcranial Doppler [ Time Frame: Perioperative Time in Laparoscopic Cholecystectomy Surgery Procedures ]
    Researchers will compete Near Infrared spectrophotometry and transcranial doppler ultrasonography methods in cerebral hemodynamics in perioperative process in laparoscopic cholecystectomy patients.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients who has;

  • Cholelithiasis,
  • Gallbladder Stones,
  • Diagnosed with acute cholecystitis
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06036498


Contacts
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Contact: Kadir Bugra Basaran +905422780016 kbugrabasaran@gmail.com

Locations
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Turkey
Bursa Uludag University, Faculty of Medicine, Department of Anesthesiology and Reanimation Recruiting
Bursa, Nilufer, Turkey, 16285
Contact: Kadir Bugra Basaran, M.D.    +905422780016    kbugrabasaran@gmail.com   
Sponsors and Collaborators
Uludag University
Investigators
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Study Chair: Kadir Bugra Basaran Uludag University
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Kadir Bugra Basaran, Medical Doctor, Research Assistant at Department of Anesthesiology and Reanimation, Uludag University
ClinicalTrials.gov Identifier: NCT06036498    
Other Study ID Numbers: Bursa Uludag Universitesi
First Posted: September 14, 2023    Key Record Dates
Last Update Posted: September 14, 2023
Last Verified: September 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Kadir Bugra Basaran, Uludag University:
Near Infra-Red Spectrophotometry
Cerebral Oxygenisation
Transcranial Doppler Ultrasonography (TCD)
Laparoscopic Surgery
Additional relevant MeSH terms:
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Cholecystitis
Acalculous Cholecystitis
Gallstones
Cholelithiasis
Cholecystolithiasis
 Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases
Calculi
Pathological Conditions, Anatomical