Evaluation of Cerebral Blood Flow and Cerebral Oxygenation With Transcranial Doppler and NIRS in Laparoscopic Cholecystectomy Cases

Cholecystitis; Gallstone Clinical Trial

— NIRS L/C  

Official title:

Evaluation of Cerebral Blood Flow and Cerebral Oxygenation With Transcranial Doppler and NIRS in Laparoscopic Cholecystectomy Cases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06036498
• Other study ID #: Bursa Uludag Universitesi
• Status: Recruiting
• Start date: January 18, 2023
• Est. completion date: June 26, 2024

Study information

• Verified date: September 2023
• Source: Uludag University
• Contact: Kadir Bugra Basaran
• Phone: +905422780016
• Email: kbugrabasaran[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 26, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Hypoperfusion
• Cholecystitis
• Cholecystitis/Cholelithiasis
• Cholecystitis; Gallstone
• Cholecystolithiasis
• Cholelithiasis
• Gallstones

Intervention

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.

Locations

Country	Name	City	State
Turkey	Bursa Uludag University, Faculty of Medicine, Department of Anesthesiology and Reanimation	Bursa	Nilufer

Sponsors (1)

Lead Sponsor	Collaborator
Uludag University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Perioperative Time in Laparoscopic Cholecystectomy Surgery Procedures
Primary	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.	Perioperative Time in Laparoscopic Cholecystectomy Surgery Procedures
Primary	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.	Perioperative Time in Laparoscopic Cholecystectomy Surgery Procedures