The Effect of Early Postoperative Pain on Postoperative Delirium (POD) in Elderly Patients Undergoing Abdominal Surgery

NCT06964893 | Completed

• 1 other identifier: PLAGH-POD-003
• Study Type: observational
• Target: 3,389
• Locations: 1 country
• Sites: 1

Brief Summary

This research project is an observational cohort study, representing a secondary analysis of multicenter prospective data from China spanning 2020 to 2022. The study aims to investigate the impact of moderate to severe acute pain on the first postoperative day (POD1) on delirium and anxiety and depression states in elderly patients undergoing abdominal surgery.

Conditions

Postoperative Delirium (POD)

Outcome Measures

Primary Outcomes (2)

• Incidence of postoperative delirium

  The incidence of postoperative delirium was assessed by a 3-minute diagnostic interview in the surgical ward (3D-CAM).

  within 7 days after surgery

• Subtype of delirium episodes

  Confusion Assessment Method (CAM) to assess the subtype of postoperative delirium, including four features: acute change or fluctuation course of mental status; inattention; altered level of consciousness; disorganized thinking.

  within 7 days after surgery

Secondary Outcomes (4)

• Incidence of anxiety state

  within 7 days postoperatively

• Incidence of depression state

  within 7 days postoperatively

• Classification of postoperative anxiety state

  within 7 days postoperatively

• Classification of postoperative depression state

  within 7 days postoperatively

Study Arms (2)

the mild pain group (NRS <4)

An NRS score \<4 on postoperative day 1 was classified as mild pain

the moderate-to-severe pain group

An NRS score ≥4 on postoperative day 1 indicated moderate-to-severe pain

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Elderly patients (≥65 years) scheduled for elective abdominal surgery under general anesthesia with endotracheal intubation, without hearing, visual, or cognitive impairments, who completed assessments for postoperative delirium, anxiety, and depression.

You may qualify if:

• ≥65 years;
• Absence of hearing, visual, or cognitive impairments (operationally defined as a Chinese version of the Mini-Mental State Examination \[MMSE\] score ≤17);
• Scheduled for elective abdominal surgery;
• Under general anesthesia with endotracheal intubation;
• Completion of postoperative delirium, anxiety, and depression assessments.

You may not qualify if:

• History of severe psychiatric disorders or chronic use of psychotropic medications;
• Surgery performed via natural orifice transluminal endoscopic surgery (NOTES) approach;
• Undergoing vascular interventional procedures;postoperative transfer to the intensive care unit (ICU);
• Death within 7 days after surgery. -

Sponsors & Collaborators

• Chinese PLA General Hospital: lead
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• The Affiliated Hospital Of Guizhou Medical University: collaborator
• Taihe Hospital: collaborator
• Xiangya Hospital of Central South University: collaborator

Study Sites (1)

Chinese PLA General Hospital, Beijing

Beijing, 100853, China

Location

Related Publications (1)

• Ma HY, Lv XC, Zhang C, Zhang ZN, Hao XY, Liu YH, Cao JB, Mi WD, Tong L, Fu Q. The effect of early postoperative acute pain on postoperative delirium in older persons undergoing abdominal surgery: a secondary analysis of multicenter prospective data. Eur Geriatr Med. 2025 Dec 2. doi: 10.1007/s41999-025-01367-w. Online ahead of print.

  PMID: 41329455 DERIVED

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Anesthesiology (Cheif expert of National key research and development program of China 2018YFC2001900)

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 11, 2025
• Study Start: April 1, 2020
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2023
• Last Updated: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)