Postoperative Delirium (POD)NCT06964893
The Effect of Early Postoperative Pain on Postoperative Delirium (POD) in Elderly Patients Undergoing Abdominal Surgery
An observational study of Postoperative Delirium (POD), run by Chinese PLA General Hospital at 1 site in China.
Trial summary
This research project is an observational cohort study, representing a secondary analysis of multicenter prospective data from China spanning 2020 to 2022. The study aims to investigate the impact of moderate to severe acute pain on the first postoperative day (POD1) on delirium and anxiety and depression states in… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Delirium (POD)
- How many people
- 3,389 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2020to 30 Apr 2023
- 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
- Older adult
Study population: Elderly patients (≥65 years) scheduled for elective abdominal surgery under general anesthesia with endotracheal intubation, without hearing, visual, or cognitive impairments, who completed assessments for postoperative delirium, anxiety, and depression.
Who may be able to join
- ≥65 years;
- Absence of hearing, visual, or cognitive impairments (operationally defined as a Chinese version of the Mini-Mental State Examination [MMSE] score ≤17);
- Scheduled for elective abdominal surgery;
- Under general anesthesia with endotracheal intubation;
- Completion of postoperative delirium, anxiety, and depression assessments.
Who cannot join
- History of severe psychiatric disorders or chronic use of psychotropic medications;
- Surgery performed via natural orifice transluminal endoscopic surgery (NOTES) approach;
- Undergoing vascular interventional procedures;postoperative transfer to the intensive care unit (ICU);
- Death within 7 days after surgery. -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Early Postoperative Pain on Postoperative Delirium (POD) in Elderly Patients Undergoing Abdominal Surgery:a Secondary Analysis of Multicenter Prospective Data
This research project is an observational cohort study, representing a secondary analysis of multicenter prospective data from China spanning 2020 to 2022. The study aims to investigate the impact of moderate to severe acute pain on the first postoperative day (POD1) on delirium and anxiety and depression states in elderly patients undergoing abdominal surgery.
Read the detailed description
Post operative delirium will be diagnosed using the 3D- CAM(Confusion Assessment Method) which tests for four features with a series of questions. The features include 1) acute onset and fluctuating course,2) inattention,3) disorganized thinking and 4) altered level of consciousness. Diagnosis of delirium is made if features 1 and 2 and either 3 or 4 are present. the investigators collected baseline characteristics and demographic data of the patients, including clinical information in the following areas:(1) Baseline characteristics: age, gender, body mass index (BMI), American Society of Anesthesiologists (ASA) physical status score, smoke, alcohol , preoperative history of chronic pain, and comorbidities (hypertension, diabetes mellitus, coronary artery disease, cerebrovascular disease, hepatic insufficiency, and renal insufficiency).(2) Preoperative laboratory tests (the most recent prior to surgery): hemoglobin (Hb), white blood cell count, and serum albumin.(3) Preoperative psychological assessments: anxiety and depression state evaluations.(4) Intraoperative variables: grade of operation, type of surgery, duration of surgery, blood transfusion, blood loss, intraoperative dexmedetomidine and nonsteroidal anti-inflammatory drugs (NSAIDs), drain, and PCIA.In this study, the investigators defined the presence or absence of moderate-to-severe pain on POD1 as the exposure variable, assessed using the Numerical Rating Scale (NRS). An NRS score <4 on POD1 was classified as mild pain, while a score ≥4 indicated moderate-to-severe pain 8. Based on this exposure variable, patients were stratified into two groups: the mild pain group (NRS <4) and the moderate-to-severe pain group (NRS ≥4).The investigators summarized patient characteristics based on the presence or absence of moderate-to-severe pain. Continuous variables were expressed as mean ± standard deviation or median (interquartile range) and compared using t-tests or Mann-Whitney U tests. Categorical variables were presented as frequencies and percentages and compared using chi-square tests. Univariate and multivariate regression models were employed to examine the relationship between early postoperative acute pain and the incidence of POD . Furthermore, propensity score matching and subgroup analyses were conducted to further explore the association between the two.
- Conditions
- Postoperative Delirium (POD)
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| the mild pain group (NRS <4) | An NRS score <4 on postoperative day 1 was classified as mild pain | |
| the moderate-to-severe pain group | An NRS score ≥4 on postoperative day 1 indicated moderate-to-severe pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative delirium
The incidence of postoperative delirium was assessed by a 3-minute diagnostic interview in the surgical ward (3D-CAM).
Measured: within 7 days after surgery
Subtype of delirium episodes
Confusion Assessment Method (CAM) to assess the subtype of postoperative delirium, including four features: acute change or fluctuation course of mental status; inattention; altered level of consciousness; disorganized thinking.
Measured: within 7 days after surgery
Secondary outcomes (4)
Incidence of anxiety state
Trained assessors evaluated postoperative anxiety using the Generalized Anxiety Disorder-7 (GAD-7) scale 10,administered at the patient's bedside during the recovery period. A score > 5 was defined as indicating anxiety symptoms.
These psychological assessments were conducted once during the postoperative hospitalization period, scheduled between postoperative days 3-7. For patients discharged before completing all assessments ( anxiety, or depression), trained researchers performed standardized telephone follow-up evaluations using the same assessment protocols.
Measured: within 7 days postoperatively
Incidence of depression state
Postoperative depressive symptoms were assessed by trained researchers using the validated Chinese version of the Patient Health Questionnaire-9 (PHQ-9) . A score > 5 was defined as indicating depressive symptoms. These psychological assessments were conducted once during the postoperative hospitalization period, scheduled between postoperative days 3-7. For patients discharged before completing all assessments ( anxiety, or depression), trained researchers performed standardized telephone follow-up evaluations using the same assessment protocols.
Measured: within 7 days postoperatively
Classification of postoperative anxiety state
Trained assessors evaluated postoperative anxiety using the Generalized Anxiety Disorder-7 (GAD-7) scale 10,administered at the patient's bedside during the recovery period. A score of 5-8 indicating mild symptoms, 9-14 representing moderate anxiety, and 15-21 reflecting severe anxiety.
Measured: within 7 days postoperatively
Classification of postoperative depression state
Postoperative depressive symptoms were assessed by trained researchers using the validated Chinese version of the Patient Health Questionnaire-9 (PHQ-9) . A score of 5-9 representing mild symptoms and 10-14 indicating moderate symptoms, 15-27 was classified as moderate-to-severe symptoms.
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 posted11 May 2025
- Study start1 Apr 2020
- Primary completion30 Apr 2022
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,389 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, The Affiliated Hospital Of Guizhou Medical University, Taihe Hospital, Xiangya Hospital of Central South University
- Responsible party
- Principal investigator, Weidong Mi, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06964893
- Sponsor's protocol ID
- PLAGH-POD-003
- Status last verified
- May 2025
- First submitted
- 29 Apr 2025
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ma HY, Lv XC, Zhang C, Zhang ZN, Hao XY, Liu YH, Cao JB, Mi WD, Tong L, Fu Q. The effect of early postoperative acute pain on postoperative delirium in older persons undergoing abdominal surgery: a secondary analysis of multicenter prospective data. Eur Geriatr Med. 2026 Apr;17(2):851-861. doi: 10.1007/s41999-025-01367-w. Epub 2025 Dec 2.
PubMed 41329455
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Early Postoperative Pain on Postoperative Delirium (POD) in Elderly Patients Undergoing Abdominal Surgery:a Secondary Analysis of Multicenter Prospective Data
- ClinicalTrials.gov ID
- NCT06964893
- Acronym / sponsor ID
- PLAGH-POD-003
- Conditions
- Postoperative Delirium (POD)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,389 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, The Affiliated Hospital Of Guizhou Medical University, Taihe Hospital, Xiangya Hospital of Central South University
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 11 May 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.
This research project is an observational cohort study, representing a secondary analysis of multicenter prospective data from China spanning 2020 to 2022. The study aims to investigate the impact of moderate to severe acute pain on the first postoperative day (POD1) on delirium and anxiety and depression states in elderly patients undergoing abdominal surgery.
Detailed description
Post operative delirium will be diagnosed using the 3D- CAM(Confusion Assessment Method) which tests for four features with a series of questions. The features include 1) acute onset and fluctuating course,2) inattention,3) disorganized thinking and 4) altered level of consciousness. Diagnosis of delirium is made if features 1 and 2 and either 3 or 4 are present. the investigators collected baseline characteristics and demographic data of the patients, including clinical information in the following areas:(1) Baseline characteristics: age, gender, body mass index (BMI), American Society of Anesthesiologists (ASA) physical status score, smoke, alcohol , preoperative history of chronic pain, and comorbidities (hypertension, diabetes mellitus, coronary artery disease, cerebrovascular disease, hepatic insufficiency, and renal insufficiency).(2) Preoperative laboratory tests (the most recent prior to surgery): hemoglobin (Hb), white blood cell count, and serum albumin.(3) Preoperative psychological assessments: anxiety and depression state evaluations.(4) Intraoperative variables: grade of operation, type of surgery, duration of surgery, blood transfusion, blood loss, intraoperative dexmedetomidine and nonsteroidal anti-inflammatory drugs (NSAIDs), drain, and PCIA.In this study, the investigators defined the presence or absence of moderate-to-severe pain on POD1 as the exposure variable, assessed using the Numerical Rating Scale (NRS). An NRS score <4 on POD1 was classified as mild pain, while a score ≥4 indicated moderate-to-severe pain 8. Based on this exposure variable, patients were stratified into two groups: the mild pain group (NRS <4) and the moderate-to-severe pain group (NRS ≥4).The investigators summarized patient characteristics based on the presence or absence of moderate-to-severe pain. Continuous variables were expressed as mean ± standard deviation or median (interquartile range) and compared using t-tests or Mann-Whitney U tests. Categorical variables were presented as frequencies and percentages and compared using chi-square tests. Univariate and multivariate regression models were employed to examine the relationship between early postoperative acute pain and the incidence of POD . Furthermore, propensity score matching and subgroup analyses were conducted to further explore the association between the two.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the mild pain group (NRS <4) | – | –An NRS score <4 on postoperative day 1 was classified as mild pain |
| the moderate-to-severe pain group | – | –An NRS score ≥4 on postoperative day 1 indicated moderate-to-severe pain |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- Elderly patients (≥65 years) scheduled for elective abdominal surgery under general anesthesia with endotracheal intubation, without hearing, visual, or cognitive impairments, who completed assessments for postoperative delirium, anxiety, and depression.
Key inclusion criteria (5 listed)
- ≥65 years;
- Absence of hearing, visual, or cognitive impairments (operationally defined as a Chinese version of the Mini-Mental State Examination [MMSE] score ≤17);
- Scheduled for elective abdominal surgery;
- Under general anesthesia with endotracheal intubation;
- Completion of postoperative delirium, anxiety, and depression assessments.
Key exclusion criteria (4 listed)
- History of severe psychiatric disorders or chronic use of psychotropic medications;
- Surgery performed via natural orifice transluminal endoscopic surgery (NOTES) approach;
- Undergoing vascular interventional procedures;postoperative transfer to the intensive care unit (ICU);
- Death within 7 days after surgery. -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of postoperative delirium
Time frame: within 7 days after surgery
The incidence of postoperative delirium was assessed by a 3-minute diagnostic interview in the surgical ward (3D-CAM).
Subtype of delirium episodes
Time frame: within 7 days after surgery
Confusion Assessment Method (CAM) to assess the subtype of postoperative delirium, including four features: acute change or fluctuation course of mental status; inattention; altered level of consciousness; disorganized thinking.
4 secondary outcomes
Incidence of anxiety state
Time frame: within 7 days postoperatively
Incidence of depression state
Time frame: within 7 days postoperatively
Classification of postoperative anxiety state
Time frame: within 7 days postoperatively
Classification of postoperative depression state
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 11 May 2025.
- Derived from this study: PubMed 41329455Ma HY, Lv XC, Zhang C, Zhang ZN, Hao XY, Liu YH, Cao JB, Mi WD, Tong L, Fu Q. The effect of early postoperative acute pain on postoperative delirium in older persons undergoing abdominal surgery: a secondary analysis of multicenter prospective data. Eur Geriatr Med. 2026 Apr;17(2):851-861. doi: 10.1007/s41999-025-01367-w. Epub 2025 Dec 2.
- Individual participant dataSharing planned: No
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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 5 inclusion and 4 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 11 May 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 (time frame: within 7 days after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06964893, which also lists 1 linked publication.
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 11 May 2025.