Image

PostoperAtive Neurocognitive Dysfunction After Major AbdomiNal Surgery (PANDAMAN)

PostoperAtive Neurocognitive Dysfunction After Major AbdomiNal Surgery (PANDAMAN)

Recruiting
65-90 years
All
Phase N/A

Powered by AI

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.

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.

Eligibility

Inclusion Criteria:

  1. 65 to 90 years old to receive elective major abdominal surgery (expected operation time over 2 hours); ,
  2. American society of Aneshesiologists(ASA)physical status I-III;

Exclusion Criteria:

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

Study details
    Elective Major Abdominal Surgery

NCT06182215

Sixth Affiliated Hospital, Sun Yat-sen University

26 June 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.