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Low Pneumoperitoneum Pressure for Delirium Prevention in Elderly Laparoscopy
Sponsor: Benha University
Summary
A randomized, double-blind trial comparing low (8-10 mmHg) versus standard (14 mmHg) intraabdominal pressure during laparoscopic pelvic surgery in patients aged 60 and older. The study aims to determine if low pressure reduces the incidence of postoperative delirium and assesses changes in optic nerve sheath diameter (ONSD) as a surrogate marker for intracranial pressure. Primary Outcome Measure: Incidence of Postoperative Delirium \[Time Frame: Postoperative Day 1 and Day 2\]. Assessed using the 4 'A's Test (4AT) screening tool. Intervention: Low-pressure pneumoperitoneum (8-10 mmHg) vs. Standard-pressure pneumoperitoneum (14 mmHg), both combined with deep neuromuscular blockade (PTC 1-2) and BIS-guided anesthesia (40-60).
Official title: Low Versus Standard Intraabdominal Pressure Impact on Postoperative Delirium in Elderly Patients Undergoing Pelvic Laparoscopy
Key Details
Gender
All
Age Range
60 Years - Any
Study Type
INTERVENTIONAL
Enrollment
110
Start Date
2026-10-26
Completion Date
2027-05-01
Last Updated
2026-10-30
Healthy Volunteers
No
Interventions
Low Intraabdominal Pressure Pneumoperitoneum
Carbon dioxide pneumoperitoneum maintained at 8-10 mmHg throughout laparoscopic pelvic surgery. This pressure level is facilitated by deep neuromuscular blockade (post-tetanic count 1-2) to preserve adequate surgical visualization without compromising the operative field.
Standard Intraabdominal Pressure Pneumoperitoneum
Carbon dioxide pneumoperitoneum maintained at 14 mmHg throughout laparoscopic pelvic surgery, representing the conventional intraoperative pressure used in standard clinical practice for this procedure.
Locations (1)
Benha University Hospital
Banhā, Qalyubia Governorate, Egypt