PostoperAtive Neurocognitive Dysfunction After Major AbdomiNal Surgery (PANDAMAN)

NCT ID: NCT06182215

Last Updated: 2024-06-17

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-11
• Study Completion Date: 2026-12-31

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.

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.

Conditions

Elective Major Abdominal Surgery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Prospective observational cohorts

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

No interventions assigned to this group

Eligibility Criteria

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).

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Xiangcai Ruan, MD, PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiangcai Ruan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sixth Affiliated Hospital, Sun Yat-sen University

Locations

The Sixth Affiliated Hospital of Sun Yet-set University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiangcai Ruan, MD, PhD

Role: CONTACT

ruanxc@mail.sysu.edu.cn

+86-13760710099

Facility Contacts

Mengying Ding

Role: primary

dingmy7@mails.sysu.edu.cn

+86-15170375679

Other Identifiers

2023-143-v2

Identifier Type: -

Identifier Source: org_study_id