PostoperAtive Neurocognitive Dysfunction After Major AbdomiNal Surgery (PANDAMAN)

NCT06182215 | Recruiting

• 1 other identifier: 2023-143-v2
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Elective Major Abdominal Surgery

Outcome Measures

Primary Outcomes (1)

• Incidence of delirium during first 7 days after surgery

  The result of 3-minute Diagnostic Interview for Confusion Assessment Method (3D-CAM) is positive.

  Consecutive 7 days after the surgery or hospital discharge, whichever comes first.

Secondary Outcomes (11)

• Preoperative cognitive function

  Day 1 before surgery

• Age-adjusted Charlson Comorbidity Index

  Day 1 before surgery

• Preoperative anxiety

  Day 1 before surgery, day 3 after surgery

• Serum biomakers levels

  Within 15 minutes after induction of anesthesia, day 3 after surgery

• Preoperative Sleep quality

  Day 1 before surgery, Day 3 after surgery

Study Arms (1)

Prospective observational cohorts

patients undergoing elective major abdominal surgery (estimated operation time over 2 hours)

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients aged 65 to 90 years who received elective major abdominal surgery (estimated operation time over 2 hours)

You may qualify if:

• 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;

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

The Sixth Affiliated Hospital of Sun Yet-set University

Guangzhou, Guangdong, 510100, China

RECRUITING

Related Publications (1)

• 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. doi: 10.1186/s12877-026-07052-2. Online ahead of print.

  PMID: 41629790 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood

Study Officials

• Xiangcai Ruan, MD, PhD

  Sixth Affiliated Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiangcai Ruan, MD, PhD

CONTACT

+86-13760710099; ruanxc@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 2, 2023
• First Posted: December 26, 2023
• Study Start: December 11, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 17, 2024

Record last verified: 2024-06

Locations

CN (1)