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Recruiting NCT06182215

PostoperAtive Neurocognitive Dysfunction After Major AbdomiNal Surgery (PANDAMAN)

— Observational Elective Major Abdominal Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Elective Major Abdominal Surgery. Basic parameters: 65 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Postoperative Neurocognitive Dysfunction After Major Abdominal Surgery: A Prospective Observational Cohort Study

Overview

Predisposing and precipitating factors for perioperative delirium for the elderly remain elusive. This research will be conducted to determine risk factors of postoperative delirium.

Detailed description

This study intends to include 500 participants over 65 years old undergoing elective abdominal major surgery. The primary outcome is incidence of delirium at 7 days postoperatively, and the secondary outcomes include preoperative sleep disorders(Athens In-somnia Scale, AIS), postoperative cognitive impairment (Abbreviated Mental Test Score, AMTS), postoperative pain (NRS pain score), incidence of significant postoperative complications, length of hospital stay, and serum biomarkers levels.

Primary outcome measures

  • Incidence of delirium during first 7 days after surgery [Time frame: Consecutive 7 days after the surgery or hospital discharge, whichever comes first.]
Secondary outcome measures (11)
  • Preoperative cognitive function [Time frame: Day 1 before surgery]
  • Age-adjusted Charlson Comorbidity Index [Time frame: Day 1 before surgery]
  • Preoperative anxiety [Time frame: Day 1 before surgery, day 3 after surgery]
  • Serum biomakers levels [Time frame: Within 15 minutes after induction of anesthesia, day 3 after surgery]
  • Preoperative Sleep quality [Time frame: Day 1 before surgery, Day 3 after surgery]
  • Postoperative pain [Time frame: Consecutive 7 days after the surgery or hospital discharge, whichever comes first.]
  • Length of hospital stay [Time frame: Up to 24 weeks after surgery]
  • Health status and quality of life [Time frame: Day 1 before surgery, day 30 after surgery]
  • Postoperative adverse complications [Time frame: Up to day 30 after surgery]
  • All-cause mortality at 30 days after surgery [Time frame: Up to day 30 after surgery]
  • Postoperative cognitive dysfunction [Time frame: Day 1 before surgery, day 30 after surgery, day 90 after surgery]

Eligibility criteria

Inclusion criteria

  • 65 to 90 years old to receive elective major abdominal surgery (expected operation time over 2 hours); ,
  • American society of Aneshesiologists（ASA）physical status I-III;

Exclusion criteria

  • Mini-Mental State Examination (MMES) score < 15;
  • Renal failure (requiring dialysis) or liver failure (Child-Pugh score > 5);
  • Severe impairment due to structural or hypoxic brain injury, more than 2 days in ICU one month before surgery;
  • Underwent major heart, lung or abdominal surgery within 1 year;
  • Positive for Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or symptomatic (e.g. fever, cough, loss of taste/smell);
  • The cognitive assessment cannot be completed because the subject is blind, deaf, or unable to communicate in the local language;
  • Long-term follow-up unavailable (homelessness, active psychosis or substance abuse).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • The Sixth Affiliated Hospital of Sun Yet-set University — Guangzhou

Publications

  • Chen H, Ding M, Ma X, Deng W, Liang B, Ruan X, Zhang X. The multidimensional physiological, psychological, and social influencing factors of perioperative neurocognitive disorders in elderly Chinese patients undergoing major abdominal surgery: study protocol of a prospective cohort study. BMC Geriatr. 2026 Feb 2;26(1):290. doi: 10.1186/s12877-026-07052-2. PMID 41629790

Identifiers

NCT: NCT06182215 · 2023-143-v2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗