The Impact of Methylprednisolone Sodium Succinate on Postoperative Delirium in Elderly Patients Undergoing Abdominal Surgery: A Target Trial Emulation Study

Glucocorticoids can be used to inhibit postoperative systemic inflammatory response syndrome. They may reduce the risk of major complications and mortality. Previous studies on the effect of glucocorticoids on postoperative cognitive dysfunction may lack generalizability due to short follow-up periods for cognitive function after surgery, insufficient follow-up results of cognitive function throughout the entire hospitalization, and a single surgical approach. Clinical evidence provided by previous randomized controlled trials may be biased due to loss-to-follow-up rates caused by researchers' failure to timely follow up on cognitive dysfunction outcomes. Most previous randomized controlled trials investigating the effect of glucocorticoids on postoperative delirium have limitations, mainly including small sample sizes and limited statistical power. Given the high cost of conducting large-scale randomized controlled trials involving various types of perioperative abdominal surgeries in elderly patients and the practical difficulty of reducing loss-to-follow-up rates, there is an urgent need to find alternative approaches. In this study, we extracted data from the in-hospital electronic medical record system and conducted a target simulation trial based on the designed randomized controlled trial protocol investigating the effect of methylprednisolone sodium succinate on postoperative delirium in elderly patients undergoing abdominal surgery. Using existing data, we analyzed whether administration of methylprednisolone sodium succinate during anesthesia induction has an impact on the incidence of postoperative delirium in elderly patients undergoing abdominal surgery.

Study Overview

• Status: Completed
• Conditions: Postoperative Delirium (POD)
• Intervention / Treatment: Drug: Administration of methylprednisolone sodium succinate during general anesthesia induction; Drug: No administration of methylprednisolone sodium succinate during general anesthesia induction

• Study Type: Observational
• Enrollment (Actual): 25800

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Chinese PLA General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients aged ≥ 65 years undergoing abdominal surgery

Description

Inclusion Criteria:

• 1、Age ≥ 65 years; 2、Patients undergoing abdominal surgery under general anesthesia, including gynecological, hepatobiliary, gastrointestinal, and urological surgeries.

Exclusion Criteria:

• 1、Patients with American Society of Anesthesiologists (ASA) physical status classification ≥ Ⅳ (including Class Ⅳ);2、Patients admitted to the intensive care unit (ICU) postoperatively; 3、Patients with a preoperative history of schizophrenia, epilepsy, or Parkinson's disease;4、Patients with diseases requiring hormone therapy for more than 7 days within 1 year prior to surgery; 5、Patients unable to communicate preoperatively (due to coma, severe dementia, or language/hearing impairment) and those with a Mini-Mental State Examination (MMSE) score < 26;6、Patients with any cerebrovascular event within the past 3 years; 7、Patients who underwent general anesthesia surgery within the past 3 months.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients aged ≥ 65 years undergoing abdominal surgery	Drug: Administration of methylprednisolone sodium succinate during general anesthesia induction; Administration of methylprednisolone sodium succinate during general anesthesia induction; Drug: No administration of methylprednisolone sodium succinate during general anesthesia induction; No administration of methylprednisolone sodium succinate during general anesthesia induction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of postoperative delirium within 3 days postoperatively	within 3 days postoperatively

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of postoperative delirium within 7 days postoperatively	within 7 days postoperatively

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): September 30, 2020
• Study Completion (Actual): October 1, 2021

Study Registration Dates

• First Submitted: November 26, 2025
• First Submitted That Met QC Criteria: November 26, 2025
• First Posted (Estimated): December 9, 2025

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Emergence Delirium
• Other Study ID Numbers: YXM02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No