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

NCT06036498 | Unknown

• 1 other identifier: Bursa Uludag Universitesi
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Hypoperfusion; Cerebral Occlusion; Cholecystitis; Gallstone; Cholecystitis/Cholelithiasis

Keywords

Near Infra-Red Spectrophotometry; Cerebral Oxygenisation; Transcranial Doppler Ultrasonography (TCD); Laparoscopic Surgery

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Other Outcomes (1)

• Detecting any difference between Near Infrared Spectrophotomery and Transcranial Doppler

  Perioperative Time in Laparoscopic Cholecystectomy Surgery Procedures

Study Arms (7)

Preoperative Assessment of Trail Group

Device: Near Infrared Spectrophotometry Device, Transcranial Doppler Ultrasonography

Post-Anaesthetic Induction Assessment of Trial Groups

Device: Near Infrared Spectrophotometry Device, Transcranial Doppler Ultrasonography

After Pneumoperitoneum Assessment of Trial Groups

Device: Near Infrared Spectrophotometry Device, Transcranial Doppler Ultrasonography

Within Head-up Tilt Position Assessment of Trial Groups

Device: Near Infrared Spectrophotometry Device, Transcranial Doppler Ultrasonography

Neuralized Position Assessment of Trial Groups

Device: Near Infrared Spectrophotometry Device, Transcranial Doppler Ultrasonography

Within Deflation of Abdomen Assessment of Trial Groups

Device: Near Infrared Spectrophotometry Device, Transcranial Doppler Ultrasonography

Awaking Period from Anaesthesia Assessment of Trial Groups

Device: Near Infrared Spectrophotometry Device, Transcranial Doppler Ultrasonography

Interventions

Near Infrared Spectrophotometry Device, Transcranial Doppler Ultrasonography DEVICE

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

After Pneumoperitoneum Assessment of Trial Groups; Awaking Period from Anaesthesia Assessment of Trial Groups; Neuralized Position Assessment of Trial Groups; Post-Anaesthetic Induction Assessment of Trial Groups; Preoperative Assessment of Trail Group; Within Deflation of Abdomen Assessment of Trial Groups; Within Head-up Tilt Position Assessment of Trial Groups

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who has; * Cholelithiasis, * Gallbladder Stones, * Diagnosed with acute cholecystitis

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uludag University: lead

Study Sites (1)

Bursa Uludag University, Faculty of Medicine, Department of Anesthesiology and Reanimation

Bursa, Nilufer, 16285, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Cerebrovascular Disorders; Cholecystitis; Gallstones; Cholelithiasis

Interventions

Ultrasonography, Doppler, Transcranial

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Echoencephalography; Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Ultrasonography; Ultrasonography, Doppler; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Kadir Bugra Basaran

  Uludag University

  STUDY CHAIR

Central Study Contacts

Kadir Bugra Basaran

CONTACT

+905422780016; kbugrabasaran@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Research Assistant at Department of Anesthesiology and Reanimation

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: September 14, 2023
• Study Start: January 18, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 26, 2024
• Last Updated: September 14, 2023

Record last verified: 2023-09

Locations

TU (1)