Low Pneumoperitoneum Pressure for Delirium Prevention in Elderly Laparoscopy

NCT07906444 · tracked via the Priya Life Science Egypt tracker

Sponsor

Benha University

Phase

Not applicable

Started

2026-10-26

Last updated

2026-10-30

Condition(s) studied

Postoperative Delirium (POD)Intracranial Hypertension

Investigational drug(s) / intervention(s)

Low Intraabdominal Pressure PneumoperitoneumStandard Intraabdominal Pressure Pneumoperitoneum

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.

Study 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).

Eligibility

Sex

ALL

Min age

60 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Age 60 years or older * ASA physical status I to III * Scheduled for elective laparoscopic pelvic surgery (pelvic oncology, gynecologic, or urologic procedures) with anticipated duration greater than 2 hours * Provide written informed consent Exclusion Criteria: * Known neurological disease or intracranial pathology (e.g., hydrocephalus, intracranial tumor, history of stroke) * Ocular pathology preventing transorbital ultrasonography (e.g., orbital trauma, severe periorbital edema, glaucoma) * History of elevated intracranial pressure * Severe cardiac or respiratory compromise, or chronic kidney disease * Emergency surgery * Pre-existing psychiatric conditions or cognitive impairment * Active substance abuse or alcohol dependence * Language barrier, hearing impairment, or severe visual impairment preventing reliable delirium assessment

Primary outcome measure(s)

Incidence of Postoperative Delirium — Postoperative Day 1 (24 hours) and Day 2 (48 hours)
Proportion of patients diagnosed with postoperative delirium, assessed using the 4 'A's Test (4AT). A total score of ≥4 indicates probable delirium.

Trial sites (1)

Facility	City	Region	Status
Benha University Hospital	Banhā	Qalyubia Governorate	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07906444 on ClinicalTrials.gov ↗ ← All trials in Egypt