Postoperative Delirium (POD) After NephrectomyNCT07892898
A Prospective Comparative Clinical Trial of Postoperative Delirium Incidence in Open Versus Laparoscopic Nephrectomy
A study testing Open Nephrectomy and Laparoscopic Nephrectomy in people with Postoperative Delirium (POD) After Nephrectomy, run by Alexandria University at 1 site in Egypt.
Trial summary
A prospective comparative clinical trial of postoperative delirium incidence in open versus laparoscopic nephrectomy Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Delirium (POD) After Nephrectomy
- What is being tested?
- Open Nephrectomy and Laparoscopic Nephrectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2026to 2 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Patients scheduled to undergo elective nephrectomy for benign or malignant renal conditions.
- American Society of Anesthesiologists (ASA) physical status classification I, II, or III.
- New York Heart Association (NYHA) functional classification class I or II.
Who cannot join
- Preoperative Mini-Mental State Examination (MMSE) score of 23 or less.
- Documented history of dementia, neurological diseases, psychiatric illness, or active drug/psychotropic substance abuse prior to admission.
- Preoperative hepatic encephalopathy grade III or IV.
- Severe visual or hearing impairments that preclude effective patient - communication.
- Emergency nephrectomy procedures.
- Inability or refusal to provide written informed consent.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Urology Department, Alexandria University Main Hospital
Alexandria, Alexandria Governorate, 112 OMAR L
About this study
Official title: A Prospective Comparative Clinial Trial of Postoperative Delirium Incidence in Open Versus Laparoscopic Nephrectomy
A prospective comparative clinical trial of postoperative delirium incidence in open versus laparoscopic nephrectomy
- Being tested
- Open Nephrectomy, Laparoscopic Nephrectomy
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open NephrectomyProcedure or surgery
Open nephrectomy
Laparoscopic NephrectomyProcedure or surgery
Laparoscopic Nephrectomy
| Study group | Role | What they receive |
|---|---|---|
| Open Nephrectomy | Active comparator | Patients undergo traditional open elective nephrectomy under standard general anesthesia. Postoperative analgesia includes regular IV ketorolac and morphine patient-controlled analgesia (PCA) for 48 hours Receives: Procedure: Open Nephrectomy |
| Laparoscopic Nephrectomy | Experimental | Patients undergo laparoscopic elective nephrectomy under standard general anesthesia. Postoperative analgesia follows the identical standardized protocol (IV ketorolac + morphine PCA). Receives: Procedure: Laparoscopic Nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postoperative Delirium
The presence or absence of delirium will be assessed using the Confusion Assessment Method (CAM). For patients who screen positive via CAM, delirium severity will be graded using the Delirium Index (DI). The DI scores 7 domains from 0 (absent) to 3 (severe), with a total score range of 0 to 21 (higher scores indicate worse severity.
Measured: Once daily on Postoperative Days (POD) 1, 2, and 3.
Secondary outcomes (4)
Postoperative Pain Intensity at Rest and During Movement
Evaluated using the Visual Analog Scale (VAS), ranging from 0 cm (no pain) to 10 cm (worst possible pain
Measured: Postoperative Days (POD) 1, 2, and 3.
Cumulative Postoperative Analgesic Consumption
Total intravenous morphine consumption (mg) via the Patient-Controlled Analgesia (PCA) device and total rescue IV morphine boluses (0.05 mg/kg) administered for breakthrough pain (VAS > 4).
Measured: Postoperative Days (POD) 1, 2, and 3.
Postoperative Functional Recovery Milestones
Time to first time sitting out of bed (hours), time to first ward ambulation (hours), time to first passage of flatus (hours), and overall length of hospital stay (days).
Measured: From end of surgery up to hospital discharge (monitored daily, up to an estimated 14 days).
Intraoperative Hemodynamic and Anesthetic Depth Parameters
Mean Arterial Pressure (MAP in mmHg), Heart Rate (HR in bpm), Bispectral Index (BIS value), Oxygen Saturation (SpO2 percentage), and Arterial Blood Gas measurements (pH, PaO2 in mmHg, PaCO2 in mmHg).
Measured: Baseline (Pre-induction, T1), 45 minutes intraoperatively (T2), 90 minutes intraoperatively (T3), and 10 minutes before the end of surgery (T4).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start1 Jan 2026
- Primary completion15 Jul 2026
- Study completion2 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Delirium (POD) After NephrectomyStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07892898
- Sponsor's protocol ID
- 0306938
- Status last verified
- May 2026
- First submitted
- 19 Oct 2026
- Last updated
- 3 Nov 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 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Comparative Clinial Trial of Postoperative Delirium Incidence in Open Versus Laparoscopic Nephrectomy
- ClinicalTrials.gov ID
- NCT07892898
- Acronym / sponsor ID
- 0306938
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 15 Jul 2026 (actual)
- Study completion
- 2 Sep 2026 (actual)
- First posted
- 23 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 prospective comparative clinical trial of postoperative delirium incidence in open versus laparoscopic nephrectomy
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open Nephrectomy | Active comparator | Procedure: Open NephrectomyPatients undergo traditional open elective nephrectomy under standard general anesthesia. Postoperative analgesia includes regular IV ketorolac and morphine patient-controlled analgesia (PCA) for 48 hours |
| Laparoscopic Nephrectomy | Experimental | Procedure: Laparoscopic NephrectomyPatients undergo laparoscopic elective nephrectomy under standard general anesthesia. Postoperative analgesia follows the identical standardized protocol (IV ketorolac + morphine PCA). |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Patients scheduled to undergo elective nephrectomy for benign or malignant renal conditions.
- American Society of Anesthesiologists (ASA) physical status classification I, II, or III.
- New York Heart Association (NYHA) functional classification class I or II.
Key exclusion criteria (6 listed)
- Preoperative Mini-Mental State Examination (MMSE) score of 23 or less.
- Documented history of dementia, neurological diseases, psychiatric illness, or active drug/psychotropic substance abuse prior to admission.
- Preoperative hepatic encephalopathy grade III or IV.
- Severe visual or hearing impairments that preclude effective patient - communication.
- Emergency nephrectomy procedures.
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 |
|---|---|---|
| Open NephrectomyOpen nephrectomy | Procedure or surgery | Open Nephrectomy |
| Laparoscopic NephrectomyLaparoscopic Nephrectomy | Procedure or surgery | Laparoscopic Nephrectomy |
Primary outcome
Incidence of Postoperative Delirium
Time frame: Once daily on Postoperative Days (POD) 1, 2, and 3.
The presence or absence of delirium will be assessed using the Confusion Assessment Method (CAM). For patients who screen positive via CAM, delirium severity will be graded using the Delirium Index (DI). The DI scores 7 domains from 0 (absent) to 3 (severe), with a total score range of 0 to 21 (higher scores indicate worse severity.
4 secondary outcomes
Postoperative Pain Intensity at Rest and During Movement
Time frame: Postoperative Days (POD) 1, 2, and 3.
Cumulative Postoperative Analgesic Consumption
Time frame: Postoperative Days (POD) 1, 2, and 3.
Postoperative Functional Recovery Milestones
Time frame: From end of surgery up to hospital discharge (monitored daily, up to an estimated 14 days).
Intraoperative Hemodynamic and Anesthetic Depth Parameters
Time frame: Baseline (Pre-induction, T1), 45 minutes intraoperatively (T2), 90 minutes intraoperatively (T3), and 10 minutes before the end of surgery (T4).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Undecided
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open Nephrectomy and Laparoscopic Nephrectomy in people with Postoperative Delirium (POD) After Nephrectomy, run by Alexandria 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 3 Nov 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Delirium (time frame: Once daily on Postoperative Days (POD) 1, 2, and 3.). 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 3 Nov 2026.