Postoperative Delirium (POD)NCT07906444
Low Pneumoperitoneum Pressure for Delirium Prevention in Elderly Laparoscopy
A study testing Low Intraabdominal Pressure Pneumoperitoneum and Standard Intraabdominal Pressure Pneumoperitoneum in people with Postoperative Delirium (POD) and Intracranial Hypertension, run by Benha University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Postoperative Delirium (POD), Intracranial Hypertension
- What is being tested?
- Low Intraabdominal Pressure Pneumoperitoneum and Standard Intraabdominal Pressure Pneumoperitoneum
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Oct 2026to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Benha University Hospital
Banhā, Qalyubia Governorate, 13511
Samar Amin, MD, +201287793991, samar.rafik@gmail.com
About this study
Official title: Low Versus Standard Intraabdominal Pressure Impact on Postoperative Delirium in Elderly Patients Undergoing Pelvic Laparoscopy
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).
Read the detailed description
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.
- Being tested
- Low Intraabdominal Pressure Pneumoperitoneum, Standard Intraabdominal Pressure Pneumoperitoneum
- Medical subject headings
- Emergence Delirium, Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Intraabdominal Pressure PneumoperitoneumProcedure or surgery
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 PneumoperitoneumProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Low Intraabdominal Pressure (8-10 mmHg) | Experimental | Not described Receives: Procedure: Low Intraabdominal Pressure Pneumoperitoneum |
| Standard Intraabdominal Pressure | Active comparator | Not described Receives: Procedure: Standard Intraabdominal Pressure Pneumoperitoneum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative Day 1 (24 hours) and Day 2 (48 hours)
Secondary outcomes (4)
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.
Measured: (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.
Measured: First 24 hours postoperatively
Intraoperative Mean Arterial Pressure
Measured: 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).
Measured: At the end of surgery (intraoperative)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start26 Oct 2026 (estimated)
- Primary completion15 Apr 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Delirium (POD)Studies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Rafik Mohamed Amin, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07906444
- Sponsor's protocol ID
- RC 2.9.2026
- Status last verified
- Oct 2026
- First submitted
- 17 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Versus Standard Intraabdominal Pressure Impact on Postoperative Delirium in Elderly Patients Undergoing Pelvic Laparoscopy
- ClinicalTrials.gov ID
- NCT07906444
- Acronym / sponsor ID
- RC 2.9.2026
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 26 Oct 2026 (estimated)
- Primary completion
- 15 Apr 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 30 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Intraabdominal Pressure (8-10 mmHg) | Experimental | Procedure: Low Intraabdominal Pressure Pneumoperitoneum |
| Standard Intraabdominal Pressure | Active comparator | Procedure: Standard Intraabdominal Pressure Pneumoperitoneum |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Intraabdominal Pressure PneumoperitoneumCarbon 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. | Procedure or surgery | Low Intraabdominal Pressure (8-10 mmHg) |
| Standard Intraabdominal Pressure PneumoperitoneumCarbon dioxide pneumoperitoneum maintained at 14 mmHg throughout laparoscopic pelvic surgery, representing the conventional intraoperative pressure used in standard clinical practice for this procedure. | Procedure or surgery | Standard Intraabdominal Pressure |
Primary outcome
Incidence of Postoperative Delirium
Time frame: 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.
4 secondary outcomes
Change in Optic Nerve Sheath Diameter (ONSD)
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)
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
Time frame: At the end of surgery (intraoperative)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Intraabdominal Pressure Pneumoperitoneum and Standard Intraabdominal Pressure Pneumoperitoneum in people with Postoperative Delirium (POD) and Intracranial Hypertension, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samar R Amin, M.D. (+201287793991, samar.rafik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Delirium (time frame: Postoperative Day 1 (24 hours) and Day 2 (48 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.