An interventional study of Low Intraabdominal Pressure Pneumoperitoneum and Standard Intraabdominal Pressure Pneumoperitoneum in Postoperative Delirium (POD) and Intracranial Hypertension, sponsored by Benha University. Recruiting at 1 site in Egypt. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Benha University · Not applicable, Interventional, and Prevention
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).
Postoperative delirium (POD) is a common and serious complication in elderly patients undergoing laparoscopic pelvic surgery, and it may be linked to the rise in intracranial pressure caused by carbon dioxide pneumoperitoneum and the Trendelenburg position. Optic nerve sheath diameter (ONSD), measured non-invasively by ultrasound, serves as a surrogate marker for intracranial pressure.
This prospective, randomized, double-blind, parallel-group trial will enroll 110 patients aged 60 years or older scheduled for elective laparoscopic pelvic surgery lasting more than 2 hours. Patients will be randomly assigned (1:1) to undergo surgery with either low intraabdominal pressure (8-10 mmHg) or standard intraabdominal pressure (14 mmHg). All patients will receive standardized general anesthesia with deep neuromuscular blockade (post-tetanic count 1-2), BIS-guided depth of anesthesia, standardized ventilation, and multimodal analgesia.
The primary objective is to determine whether low intraabdominal pressure reduces the incidence of POD, assessed with the 4AT on postoperative Days 1 and 2. The secondary objective is to compare changes in ONSD across four intraoperative time points and to explore the relationship between ONSD changes and POD occurrence. The trial is designed to clarify whether reducing pneumoperitoneum pressure mitigates intracranial pressure elevation and lowers delirium risk in this vulnerable population.
795 studies on the registry are indexed under Emergence Delirium; 257 are open to participants now.
This study's planned enrollment of 110 is close to the median of 120 across 496 interventional studies indexed under Emergence Delirium.
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Exclusion Criteria:
Procedure: Low Intraabdominal Pressure Pneumoperitoneum
Procedure: Standard 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.
Carbon dioxide pneumoperitoneum maintained at 14 mmHg throughout laparoscopic pelvic surgery, representing the conventional intraoperative pressure used in standard clinical practice for this procedure.
Incidence of Postoperative Delirium
Proportion of patients diagnosed with postoperative delirium, assessed using the 4 'A's Test (4AT). A total score of ≥4 indicates probable delirium.
Time frame: Postoperative Day 1 (24 hours) and Day 2 (48 hours)
Change in Optic Nerve Sheath Diameter (ONSD)
Change in ONSD from baseline (post-intubation, before pneumoperitoneum) measured by transorbital ultrasonography as a surrogate marker for intracranial pressure.
Time frame: (after intubation, before pneumoperitoneum); 10 minutes after pneumoperitoneum initiation in Trendelenburg position; 60 minutes after pneumoperitoneum initiation; 10 minutes after desufflation and return to neutral position
Postoperative Pain Intensity (Numeric Rating Scale)
Pain intensity assessed using the Numeric Rating Scale (NRS), an 11-point scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate worse pain.
Time frame: First 24 hours postoperatively
Intraoperative Mean Arterial Pressure
Time frame: Baseline (after intubation, before pneumoperitoneum); 10 minutes after pneumoperitoneum initiation in Trendelenburg position; 60 minutes after pneumoperitoneum initiation; 10 minutes after desufflation and return to neutral position
Surgeon Satisfaction with Surgical Conditions
Surgeon-rated quality of the surgical field using a validated 4-point surgical space rating scale (1 = optimal to 4 = poor).
Time frame: At the end of surgery (intraoperative)
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Start is estimated for Oct 2026; primary completion for Apr 2027, 5 months later.
Of 197 non-industry interventional studies with no phase under Emergence Delirium, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 39. This study's planned 5 months is below that.
Counting every sponsor, half of 198 studies reached it within 21 months; a quarter within 8 and three quarters within 39.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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