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Low Pneumoperitoneum Pressure for Delirium Prevention in Elderly Laparoscopy

RecruitingNAAges 60 Years - anyAllBenha University
NCT07906444 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

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).

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๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Low Intraabdominal Pressure Pneumoperitoneum
  • Standard Intraabdominal Pressure Pneumoperitoneum
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Where

1 site
Benha University Hospital
Banhฤ, Egypt
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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