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RECRUITING
NCT07906444
NA

Low Pneumoperitoneum Pressure for Delirium Prevention in Elderly Laparoscopy

Sponsor: Benha University

View on ClinicalTrials.gov

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

PROCEDURE

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.

PROCEDURE

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