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

NCT07892898 | Completed

• 1 other identifier: 0306938
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postoperative Delirium (POD) After Nephrectomy

Outcome Measures

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.

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

Secondary Outcomes (4)

• Postoperative Pain Intensity at Rest and During Movement

  Postoperative Days (POD) 1, 2, and 3.

• Cumulative Postoperative Analgesic Consumption

  Postoperative Days (POD) 1, 2, and 3.

• Postoperative Functional Recovery Milestones

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

• Intraoperative Hemodynamic and Anesthetic Depth Parameters

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

Study Arms (2)

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

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).

Procedure: Laparoscopic Nephrectomy

Interventions

Open Nephrectomy PROCEDURE

Open nephrectomy

Open Nephrectomy

Laparoscopic Nephrectomy PROCEDURE

Laparoscopic Nephrectomy

Laparoscopic Nephrectomy

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Urology Department, Alexandria University Main Hospital

Alexandria, Alexandria Governorate, 112 OMAR L, Egypt

Location

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2026
• First Posted: October 23, 2026
• Study Start: January 1, 2026
• Primary Completion: July 15, 2026
• Study Completion: September 2, 2026
• Last Updated: October 23, 2026

Record last verified: 2026-05

Locations

EG (1)