Postoperative Delirium (POD)NCT07877285
Immunonutrition and Neuromonitoring for Postoperative Delirium in Gynecologic Oncology
An observational study of Postoperative Delirium (POD) and Gynecologic Cancers, run by Elazıg Fethi Sekin Sehir Hastanesi at 1 site in Turkey (Türkiye).
Trial summary
Early postoperative delirium (POD) is a common and distressing neuropsychiatric complication frequently observed in elderly patients undergoing major surgical interventions, including radical and cytoreductive gynecologic oncological procedures (such as ovarian, cervical, and endometrial cancer surgeries). Read more about this study
- Who is it for?
- Ages 65 to 80 years, women only
- Conditions the study is for
- Postoperative Delirium (POD), Gynecologic Cancers, Malnutitrion
- What is being tested?
- Preoperative Immunonutritional Scoring and Intraoperative Neuromonitoring
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2026to 1 Feb 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
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 80 years
- Women only
- No healthy volunteers
- Older adult
Study population: Elderly female patients aged 65 years and older undergoing elective major cytoreductive or radical oncological surgery for gynecologic malignancies (including ovarian and cervical cancers) under general anesthesia at a tertiary care medical center.
Who may be able to join
- Female patients aged 65 years or older.
- Scheduled for elective major gynecologic oncological surgery (e.g., radical hysterectomy, cytoreductive surgery for ovarian, cervical, or endometrial cancer).
- American Society of Anesthesiologists (ASA) physical status II-IV.
- Planned to undergo general anesthesia with continuous intraoperative neuromonitoring / processed EEG.
- Signed written informed consent provided prior to surgery.
Who cannot join
- Pre-existing dementia, significant cognitive impairment, or baseline Mini-Mental State Examination (MMSE) score below validated cut-offs.
- History of major neuropsychiatric disorders, active neurodegenerative disease, or acute cerebrovascular accident within the preceding 6 months.
- Patients undergoing emergency surgical procedures.
- Uncorrected severe sensory deficits (auditory or visual impairments) precluding postoperative delirium assessments.
- Missing preoperative baseline nutritional or hematological laboratory parameters required for CONUT or Naples scoring.
- Inability to comply with post-anesthesia cognitive evaluations or re-operation required during the observation window.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Fethi Sekin City Hospital
Elâzığ, Elâzığ, 23000
Muhammed Başpınar, M.D. / Specialist, +90 539 583 11 41, bspnr.muhammed@gmail.com
About this study
Official title: Predictive Value of Preoperative CONUT and Naples Prognostic Scores Combined With Intraoperative Neuromonitoring for Early Postoperative Delirium in Elderly Patients Undergoing Gynecologic Oncological Surgery: A Prospective Study
Early postoperative delirium (POD) is a common and distressing neuropsychiatric complication frequently observed in elderly patients undergoing major surgical interventions, including radical and cytoreductive gynecologic oncological procedures (such as ovarian, cervical, and endometrial cancer surgeries). Delirium is associated with prolonged hospital and intensive care unit stays, functional decline, elevated healthcare expenditures, and increased perioperative morbidity.
The pathogenesis of postoperative delirium is multifactorial, involving baseline patient vulnerability and intraoperative triggering factors. Malnutrition and systemic inflammation are recognized as critical predisposing factors that disrupt blood-brain barrier integrity and trigger neuroinflammatory cascades. The Controlling Nutritional Status (CONUT) score and the Naples Prognostic Score (NPS) are objective scoring systems combining nutritional biomarkers (serum albumin, total cholesterol) and immune-inflammatory markers (absolute lymphocyte count, neutrophil-to-lymphocyte ratio, and lymphocyte-to-monocyte ratio). Concurrently, intraoperative neuromonitoring (such as processed electroencephalography / bispectral index monitoring) provides continuous assessment of cerebral anesthetic depth and electrophysiological patterns like burst suppression, which have been implicated in acute cerebral dysfunction.
The objective of this prospective observational study is to evaluate the individual and combined predictive utility of preoperative immunonutritional indices (CONUT and Naples Prognostic Score) alongside intraoperative neuromonitoring parameters for the occurrence of early postoperative delirium in elderly patients undergoing elective gynecologic oncological surgery.
Read the detailed description
Elderly patients presenting for major gynecologic oncological surgeries frequently exhibit subclinical cachexia, hypoalbuminemia, and chronic systemic inflammation resulting from both malignancy and advanced age. These baseline alterations can accentuate central nervous system vulnerability during surgical stress. Concurrently, extensive open or laparoscopic cytoreductive surgeries often require extended operative durations and deep general anesthesia, increasing the likelihood of intraoperative cerebral hypoperfusion, excessive anesthetic depth, or prolonged burst suppression patterns.
Although preoperative nutritional deficiency and systemic inflammation have individually been linked to adverse surgical outcomes, the synergistic predictive capability of comprehensive immunonutritional scores-specifically the CONUT score and the Naples Prognostic Score (NPS)-in conjunction with real-time intraoperative cerebral depth monitoring remains unexplored in gynecologic oncology cohorts.
In this prospective observational cohort study, consecutive female patients aged 65 years and older scheduled for elective major gynecologic oncological surgeries (e.g., radical hysterectomy, cytoreductive surgery for ovarian, cervical, or endometrial malignancies) under general anesthesia will be enrolled.
Prior to surgery, standard preoperative laboratory workups will be documented to calculate:
The CONUT score: based on serum albumin levels, total cholesterol concentrations, and absolute peripheral lymphocyte counts.
The Naples Prognostic Score: combining serum albumin, total cholesterol, neutrophil-to-lymphocyte ratio (NLR), and lymphocyte-to-monocyte ratio (LMR).
Intraoperatively, all participants will receive standardized general anesthesia with continuous processed EEG / neuromonitoring (recording index values, duration spent below target anesthetic depth, and presence/duration of burst suppression). Postoperative delirium will be screened prospectively using a validated screening tool (such as the CAM-ICU or 3D-CAM) twice daily during the first 72 postoperative hours.
Univariable and multivariable logistic regression analyses, together with Receiver Operating Characteristic (ROC) curve comparisons, will be performed to determine the predictive accuracy, sensitivity, specificity, and optimal cut-off thresholds for CONUT, Naples Prognostic Score, and intraoperative neuromonitoring parameters in identifying elderly patients at high risk for early postoperative delirium.
- Being tested
- Preoperative Immunonutritional Scoring and Intraoperative Neuromonitoring
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative Immunonutritional Scoring and Intraoperative NeuromonitoringDiagnostic test
Preoperative assessment comprises the calculation of the Controlling Nutritional Status (CONUT) score (evaluating serum albumin, total cholesterol, and total lymphocyte count) and the Naples Prognostic Score (integrating albumin, cholesterol, neutrophil-to-lymphocyte ratio, and lymphocyte-to-monocyte ratio) from routine pre-incision blood samples. Intraoperatively, patients receive standard general anesthesia accompanied by continuous processed EEG / neuromonitoring to track anesthetic depth indices and electroencephalographic burst suppression patterns. Delirium screening is conducted during the early postoperative period.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Early Postoperative Delirium
Area under the receiver operating characteristic curve (AUC-ROC) of the preoperative Controlling Nutritional Status (CONUT) score for predicting early postoperative delirium.
Measured: Baseline to 72 hours postoperatively
Secondary outcomes (4)
Predictive Performance of Baseline CONUT Score for Delirium
Discriminative performance evaluated via Receiver Operating Characteristic (ROC) curve analysis, calculating the Area Under the Curve (AUC), sensitivity, and specificity of baseline Controlling Nutritional Status (CONUT) and Naples Prognostic scores for predicting postoperative delirium.
Measured: Preoperative baseline through postoperative day 1
Predictive Performance of Baseline Naples Prognostic Score for Delirium
Area under the receiver operating characteristic curve (AUC-ROC) of the preoperative Naples Prognostic Score for predicting early postoperative delirium.
Measured: Baseline to 72 hours postoperatively
Cumulative Duration of Deep Anesthesia (BIS < 40)
Total intraoperative duration (in minutes) spent at excessive anesthetic depth, defined as Bispectral Index (BIS) values below 40.
Measured: Intraoperative period (from anesthesia induction to extubation)
Length of Postoperative Hospital Stay
Total duration of hospitalization (measured in days) from the date of surgery until hospital discharge.
Measured: Up to 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start1 Oct 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Feb 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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Elazıg Fethi Sekin Sehir Hastanesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed Başpınar, Elazıg Fethi Sekin Sehir Hastanesi
- Investigators
- Muhammed BaŞpınar, M.D., Principal investigator, Elazıg Fethi Sekin Sehir Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07877285
- Sponsor's protocol ID
- 2026/33-33
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that underlie the results reported in the published article will be made available to researchers who provide a methodologically sound proposal.