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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07271394
Enrollment
25800
Registered
2025-12-09
Start date
2018-10-01
Completion date
2021-10-01
Last updated
2025-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Delirium (POD)

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.

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

Sponsors

Chinese PLA General Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Incidence of postoperative delirium within 3 days postoperativelywithin 3 days postoperatively

Secondary

MeasureTime frame
Incidence of postoperative delirium within 7 days postoperativelywithin 7 days postoperatively

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026