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

September 6, 2023 updated by: Kadir Bugra Basaran, Uludag University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
    • Nilufer
      • Bursa, Nilufer, Turkey, 16285
        • Recruiting
        • Bursa Uludag University, Faculty of Medicine, Department of Anesthesiology and Reanimation
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Patients who has;

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Perioperative Time in Laparoscopic Cholecystectomy Surgery Procedures
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.
Perioperative Time in Laparoscopic Cholecystectomy Surgery Procedures

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Perioperative Time in Laparoscopic Cholecystectomy Surgery Procedures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uludag University

Investigators

  • Study Chair: Kadir Bugra Basaran, Uludag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 26, 2024

Study Registration Dates

First Submitted

August 30, 2023

First Submitted That Met QC Criteria

September 6, 2023

First Posted (Actual)

September 14, 2023

Study Record Updates

Last Update Posted (Actual)

September 14, 2023

Last Update Submitted That Met QC Criteria

September 6, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bursa Uludag Universitesi

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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