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CompletedNCT07892898Updated Oct 23, 2026

A Prospective Comparative Clinical Trial of Postoperative Delirium Incidence in Open Versus Laparoscopic Nephrectomy

An interventional study of Open Nephrectomy and Laparoscopic Nephrectomy in Postoperative Delirium (POD) After Nephrectomy, sponsored by Alexandria University. Completed at 1 site in Egypt. Open to participants aged 65 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-23.

Sponsored by Alexandria University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Jan 2026, registered Oct 2026).
Updated Oct 23, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
134
Allocation
Randomized
Ages
65 Years to 85 Years
Sex
All
01

Study summary

A prospective comparative clinical trial of postoperative delirium incidence in open versus laparoscopic nephrectomy

02

Conditions studied

  • Postoperative Delirium (POD) After Nephrectomy

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03

In context

Emergence Delirium

788 studies on the registry are indexed under Emergence Delirium; 250 are open to participants now.

This study's enrollment of 134 is above the median of 120 across 491 interventional studies indexed under Emergence Delirium.

Browse Emergence Delirium studies →

Lead sponsor

Alexandria University is the lead sponsor of 586 studies on the registry; 128 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

- 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.

Exclusion criteria

Exclusion Criteria:

  • 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.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
134 participants (actual)

Study arms

  • Active comparator
    Open Nephrectomy

    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

    Procedure: Open Nephrectomy

  • Experimental
    Laparoscopic Nephrectomy

    Patients undergo laparoscopic elective nephrectomy under standard general anesthesia. Postoperative analgesia follows the identical standardized protocol (IV ketorolac + morphine PCA).

    Procedure: Laparoscopic Nephrectomy

Interventions

  • ProcedureOpen Nephrectomy

    Open nephrectomy

  • ProcedureLaparoscopic Nephrectomy

    Laparoscopic Nephrectomy

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Once daily on Postoperative Days (POD) 1, 2, and 3.

Secondary outcomes

  1. 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

    Time frame: Postoperative Days (POD) 1, 2, and 3.

  2. 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).

    Time frame: Postoperative Days (POD) 1, 2, and 3.

  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).

    Time frame: From end of surgery up to hospital discharge (monitored daily, up to an estimated 14 days).

  4. 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).

    Time frame: Baseline (Pre-induction, T1), 45 minutes intraoperatively (T2), 90 minutes intraoperatively (T3), and 10 minutes before the end of surgery (T4).

07

Study locations

1 site
  • Urology Department, Alexandria University Main Hospital
    Alexandria, Alexandria Governorate 112 OMAR L, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 23, 2026
Show all 1 update
  1. Oct 23, 2026
    First appeared on the registry

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 ↗

10

Registry details

Key details

Study ID
NCT07892898
Responsible party
Sponsor
First posted
Oct 23, 2026
Start date
Jan 1, 2026
Primary completion
Jul 15, 2026
Completion
Sep 2, 2026
Last update
Oct 23, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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