Lower pressure during laparoscopic surgery to prevent delirium in older adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind trial compares low intraabdominal pressure (8-10 mmHg) with standard pressure (14 mmHg) during elective laparoscopic pelvic surgery in patients 60 years and older. All participants receive deep neuromuscular blockade and BIS-guided anesthesia with multimodal analgesia. The primary outcome is the rate of postoperative delirium on days 1 and 2, measured with the 4AT; secondary outcomes include changes in optic nerve sheath diameter as a surrogate for intracranial pressure. The study aims to determine if lower pneumoperitoneum mitigates intracranial pressure elevations and reduces delirium risk in this high-risk population.

Why it matters

Who can join: the full rules

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

Where it's running

• Benha University Hospital
  Banhā, Qalyubia Governorate, Egypt Recruiting

Study contacts

• Study coordinator: Samar R Amin, M.D.
• Email: samar.rafik@gmail.com
• Phone: +201287793991

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.