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CompletedNCT07271394Updated Dec 9, 2025

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

An observational study in Postoperative Delirium (POD), sponsored by Chinese PLA General Hospital. Completed at 1 site in China. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-12-09.

Sponsored by Chinese PLA General Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
25,800
Ages
65 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Postoperative Delirium (POD)

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03

In context

Emergence Delirium

763 studies on the registry are indexed under Emergence Delirium; 241 are open to participants now.

This study's enrollment of 25,800 is above the median of 164 across 280 observational studies indexed under Emergence Delirium.

Browse Emergence Delirium studies →

Lead sponsor

Chinese PLA General Hospital is the lead sponsor of 558 studies on the registry; 202 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients aged ≥ 65 years undergoing abdominal surgery

Inclusion criteria

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

Exclusion criteria

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.
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
25,800 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • DrugAdministration of methylprednisolone sodium succinate during general anesthesia induction

    Administration of methylprednisolone sodium succinate during general anesthesia induction

  • DrugNo administration of methylprednisolone sodium succinate during general anesthesia induction

    No administration of methylprednisolone sodium succinate during general anesthesia induction

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What researchers measure

Primary outcomes

  1. Incidence of postoperative delirium within 3 days postoperatively

    Time frame: within 3 days postoperatively

Secondary outcomes

  1. Incidence of postoperative delirium within 7 days postoperatively

    Time frame: within 7 days postoperatively

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Study locations

1 site
  • Chinese PLA General Hospital
    Beijing, China
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07271394
Lead sponsor
Chinese PLA General Hospital
Responsible party
Jingsheng Lou (Professor, Chinese PLA General Hospital) — Principal investigator
First posted
Dec 9, 2025
Start date
Oct 1, 2018
Primary completion
Sep 30, 2020
Completion
Oct 1, 2021
Last update
Dec 9, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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