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

NCT07271394 | Completed DMC

• 1 other identifier: YXM02
• Study Type: observational
• Target: 25,800
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Delirium (POD)

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative delirium within 3 days postoperatively

  within 3 days postoperatively

Secondary Outcomes (1)

• Incidence of postoperative delirium within 7 days postoperatively

  within 7 days postoperatively

Study Arms (1)

Patients aged ≥ 65 years undergoing abdominal surgery

Drug: Administration of methylprednisolone sodium succinate during general anesthesia induction; Drug: No administration of methylprednisolone sodium succinate during general anesthesia induction

Interventions

Administration of methylprednisolone sodium succinate during general anesthesia induction DRUG

Administration of methylprednisolone sodium succinate during general anesthesia induction

Patients aged ≥ 65 years undergoing abdominal surgery

No administration of methylprednisolone sodium succinate during general anesthesia induction DRUG

No administration of methylprednisolone sodium succinate during general anesthesia induction

Patients aged ≥ 65 years undergoing abdominal surgery

Eligibility Criteria

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

Study Population

Patients aged ≥ 65 years undergoing abdominal surgery

You may qualify if:

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

You may not qualify if:

• 、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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, China

Location

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: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 9, 2025
• Study Start: October 1, 2018
• Primary Completion: September 30, 2020
• Study Completion: October 1, 2021
• Last Updated: December 9, 2025

Record last verified: 2018-10

Locations

CN (1)