Evaluating blood flow and oxygen levels in the brain during laparoscopic gallbladder surgery
Evaluation of Cerebral Blood Flow and Cerebral Oxygenation With Transcranial Doppler and NIRS in Laparoscopic Cholecystectomy Cases
This study is testing how blood flow and oxygen levels in the brain change during laparoscopic gallbladder surgery to see if certain techniques can help understand any risks involved.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Uludag University Academic / other |
| Locations | 1 site (Bursa, Nilufer) |
| Trial ID | NCT06036498 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess changes in cerebral blood flow and oxygenation in patients undergoing laparoscopic cholecystectomy, particularly focusing on the effects of pneumoperitoneum. Researchers will utilize Near Infrared Spectrophotometry (NIRS) and Transcranial Doppler Ultrasonography (TCD) to monitor these changes. The study will compare the outcomes of both assessment methods to determine any significant differences. The findings could provide insights into the neurological risks associated with prolonged laparoscopic surgeries.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with an ASA classification of 1-3 scheduled for elective laparoscopic cholecystectomy.
Not a fit: Patients with ASA classification of 4 and above, those under 18 or over 65, and individuals with a history of cerebrovascular issues will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance patient safety by identifying potential neurological complications during laparoscopic surgeries.
How similar studies have performed: While the approach of using NIRS and TCD in this context is relatively novel, similar studies have shown promise in monitoring cerebral perfusion during surgical procedures.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bursa, Nilufer
- Bursa Uludag University, Faculty of Medicine, Department of Anesthesiology and Reanimation — Bursa, Nilufer, Turkey (Recruiting)
Study contacts
- Study coordinator: Kadir Bugra Basaran
- Email: kbugrabasaran@gmail.com
- Phone: +905422780016
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.