Effects of PEEP on optic nerve sheath diameter during laparoscopic cholecystectomy
The Effects of Positive End-Expiratory Pressure (PEEP) on Optic Nerve Sheath Diameter (ONSD) in Patients Undergoing Laparoscopic Cholecystectomy Under General Anesthesia: A Prospective Interventional Study
This study is testing if using a breathing technique called PEEP during gallbladder surgery affects the pressure around the optic nerve in patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Nigde Omer Halisdemir University Academic / other |
| Locations | 1 site (Niğde, Niğde Province) |
| Trial ID | NCT06979999 on ClinicalTrials.gov |
What this trial studies
This interventional study evaluates how applying positive end-expiratory pressure (PEEP) at 10 cmH₂O affects the optic nerve sheath diameter (ONSD) in patients undergoing elective laparoscopic cholecystectomy under general anesthesia. Approximately 80 adult patients will be monitored at three specific intraoperative time points to measure ONSD using high-frequency ultrasound, alongside other vital parameters like dynamic lung compliance and end-tidal CO₂. The goal is to determine if PEEP influences indicators of intracranial pressure during these procedures.
Who should consider this trial
Good fit: Ideal candidates are adult patients aged 18 and older, classified as ASA physical status I-III, scheduled for elective laparoscopic cholecystectomy.
Not a fit: Patients with acute or chronic eye diseases, uncontrolled hypertension, chronic pulmonary diseases, neurological disorders, or a BMI over 35 kg/m² may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of intracranial pressure management during laparoscopic surgeries, potentially improving patient outcomes.
How similar studies have performed: While the specific application of PEEP in this context may be novel, similar studies have explored the effects of mechanical ventilation strategies on intracranial pressure indicators.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- Adult patients (age ≥ 18 years) American Society of Anesthesiologists (ASA) physical status I-III Scheduled for elective laparoscopic cholecystectomy under general anesthesia Signed informed consent Exclusion Criteria: * resence of acute or chronic eye disease Uncontrolled hypertension Asthma or known chronic pulmonary disease Any neurological disorders Body mass index (BMI) \> 35 kg/m² Use of medications known to affect intracranial pressure Refusal to participate after signing informed consent
Where this trial is running
Niğde, Niğde Province
- Niğde Training and Research Hospital — Niğde, Niğde Province, Turkey (Türkiye) (Recruiting)
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.