Postoperative Delirium (POD)NCT07271394
The Impact of Methylprednisolone Sodium Succinate on Postoperative Delirium in Elderly Patients Undergoing Abdominal Surgery: A Target Trial Emulation Study
An observational study of Postoperative Delirium (POD), run by Chinese PLA General Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Delirium (POD)
- What is being tested?
- Administration of methylprednisolone sodium succinate during general anesthesia induction and No administration of methylprednisolone sodium succinate during general anesthesia induction
- How many people
- 25,800 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2018to 1 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients aged ≥ 65 years undergoing abdominal surgery
Who may be able to join
- 1、Age ≥ 65 years; 2、Patients undergoing abdominal surgery under general anesthesia, including gynecological, hepatobiliary, gastrointestinal, and urological surgeries.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this 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.
- Conditions
- Postoperative Delirium (POD)
- Being tested
- Administration of methylprednisolone sodium succinate during general anesthesia induction, No administration of methylprednisolone sodium succinate during general anesthesia induction
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of methylprednisolone sodium succinate during general anesthesia inductionDrug
Administration of methylprednisolone sodium succinate during general anesthesia induction
No administration of methylprednisolone sodium succinate during general anesthesia inductionDrug
No administration of methylprednisolone sodium succinate during general anesthesia induction
| Study group | Role | What they receive |
|---|---|---|
| Patients aged ≥ 65 years undergoing abdominal surgery | Not described Receives: Drug: Administration of methylprednisolone sodium succinate during general anesthesia induction; Drug: No administration of methylprednisolone sodium succinate during general anesthesia induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative delirium within 3 days postoperatively
Measured: within 3 days postoperatively
Secondary outcomes (1)
Incidence of postoperative delirium within 7 days postoperatively
Measured: within 7 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start1 Oct 2018
- Primary completion30 Sep 2020
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Delirium (POD)Studies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 25,800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingsheng Lou, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07271394
- Sponsor's protocol ID
- YXM02
- Status last verified
- Oct 2018
- First submitted
- 26 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Methylprednisolone Sodium Succinate on Postoperative Delirium in Elderly Patients Undergoing Abdominal Surgery: A Target Trial Emulation Study
- ClinicalTrials.gov ID
- NCT07271394
- Acronym / sponsor ID
- YXM02
- Conditions
- Postoperative Delirium (POD)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25,800 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients aged ≥ 65 years undergoing abdominal surgery
Key inclusion criteria (1 listed)
- 1、Age ≥ 65 years; 2、Patients undergoing abdominal surgery under general anesthesia, including gynecological, hepatobiliary, gastrointestinal, and urological surgeries.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Administration of methylprednisolone sodium succinate during general anesthesia inductionAdministration of methylprednisolone sodium succinate during general anesthesia induction | Drug | Patients aged ≥ 65 years undergoing abdominal surgery |
| No administration of methylprednisolone sodium succinate during general anesthesia inductionNo administration of methylprednisolone sodium succinate during general anesthesia induction | Drug | Patients aged ≥ 65 years undergoing abdominal surgery |
Primary outcome
Incidence of postoperative delirium within 3 days postoperatively
Time frame: within 3 days postoperatively
1 secondary outcome
Incidence of postoperative delirium within 7 days postoperatively
Time frame: within 7 days postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
Related trials for Postoperative Delirium (POD)
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Not yet recruitingObservational study
Comparison of IV Dexmedetomidine Versus Clonidine Versus no Alpha 2 Agonist on Emergency Delirium, PACU Length of Stay and Time to Hospital Discharge in Children Undergoing (Adeno)Tonsillectomy: a Prospective Observational Study
Emergency Delirium, Postoperative Delirium (POD)
Recruiting
Low Pneumoperitoneum Pressure for Delirium Prevention in Elderly Laparoscopy
Postoperative Delirium (POD), Intracranial Hypertension
Not yet recruitingPhase 4
Effects of Remimazolam on Postoperative Cognitive Dysfunction and Neuroinflammatory Biomarkers in Patients Undergoing Aortic Arch Surgery
Aortic Aneurysm of the Proximal Arch, Aortic Aneurysms Arch
RecruitingObservational study
Immunonutrition and Neuromonitoring for Postoperative Delirium in Gynecologic Oncology
Postoperative Delirium (POD), Gynecologic Cancers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Delirium (POD), run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative delirium within 3 days postoperatively (time frame: within 3 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.