NCT07906444Recruiting
Low Pneumoperitoneum Pressure for Delirium Prevention in Elderly Laparoscopy
Low Versus Standard Intraabdominal Pressure Impact on Postoperative Delirium in Elderly Patients Undergoing Pelvic Laparoscopy
Source: ClinicalTrials.gov · Last updated 30 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- First submitted
- 17 Oct 2026
- Start date
- Oct 2026
- Primary completion date
- Apr 2027
- Lead sponsor
- Benha University
- Diseases
- High blood pressure
- NCT number
- NCT07906444
What you commit to
- Study type: Interventional
- Planned participants: 110
- From Oct 2026 to the primary completion date, Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Emergency surgery
Other illness
- Known neurological disease or intracranial pathology (e.g., hydrocephalus, intracranial tumor, history of stroke)
- History of elevated intracranial pressure
- Severe cardiac or respiratory compromise, or chronic kidney disease
- Pre-existing psychiatric conditions or cognitive impairment
- Language barrier, hearing impairment, or severe visual impairment preventing reliable delirium assessment
Other
- Ocular pathology preventing transorbital ultrasonography (e.g., orbital trauma, severe periorbital edema, glaucoma)
- Active substance abuse or alcohol dependence
Who the study is looking for
- 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
Age in the registry: 60 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Benha University Hospital Coordinator of this site? Confirm its status | Banhā | Egypt | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.