Postoperative Delirium (POD)NCT07502391
Sex-Dependent Risk of Postoperative Delirium and Mediating Effects of Family Visits
An observational study of Postoperative Delirium (POD) and Sex Differences, run by Julian Rössler at 1 site in Switzerland.
Trial summary
Postoperative delirium is a common and serious complication after surgery, affecting 10-40% of older patients undergoing non-cardiac procedures. It is characterized by sudden changes in attention, awareness, and thinking that fluctuate throughout the day. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Delirium (POD), Sex Differences
- How many people
- 471 participants
- Where
- 1 siteSwitzerland
- Study dates
- 5 May 2026to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 and older who are having noncardiac surgery
Who may be able to join
- Informed consent as documented by signature;
- ≥65 years of age;
- Scheduled non-cardiac surgery with expected surgery duration ≥ 2 hours;
- Under either general or spinal anesthesia.
Who cannot join
- Known drug or alcohol abuse;
- Requirement for postoperative ventilation;
- Current participation in another study with an investigational drug;
- Inability to complete the study assessments.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Universitätsspital Zürich
Zurich
Julian Rössler, M.D., +41442551111, julian.roessler@usz.ch
About this study
Official title: Sex-Dependent Risk of Postoperative Delirium and Mediating Effects of Family Visits: A Prospective Observational Study
Postoperative delirium is a common and serious complication after surgery, affecting 10-40% of older patients undergoing non-cardiac procedures. It is characterized by sudden changes in attention, awareness, and thinking that fluctuate throughout the day. Delirium is associated with longer hospital stays, higher mortality, worse long-term brain function, and substantially increased healthcare costs. While several risk factors are known, it remains unclear whether a patient's sex independently influences the risk of developing postoperative delirium, as existing studies have produced conflicting results and were often not designed to specifically examine sex differences.Family visitation is a promising non-drug approach to preventing delirium. Studies in intensive care patients have shown that those who receive family visits have a significantly lower risk of developing delirium. However, it is unknown whether men and women receive different amounts of family visits after surgery, and whether any such difference could help explain sex-based disparities in delirium risk. Given that traditional gender roles in caregiving persist, women - who often serve as primary caregivers in their families - may receive fewer visits when they themselves become patients.This prospective observational study led by the University of Zurich will enroll 471 patients aged 65 years or older undergoing non-cardiac surgery lasting at least 2 hours under general or spinal anesthesia. The primary aim is to determine whether female patients have a higher risk of developing postoperative delirium within three days after surgery compared to male patients. Delirium will be assessed twice daily using the 4 A's Test (4AT), a validated and standardized screening tool. The secondary aim is to evaluate whether female patients receive fewer family visits than male patients and whether any difference in visitation mediates the sex-dependent delirium risk. Family visits will be recorded using an anonymous sign-in sheet placed in the patient's room. The study does not involve any experimental interventions; all patients receive standard clinical care. Participation is voluntary, and withdrawal is possible at any time without affecting medical treatment.
- Conditions
- Postoperative Delirium (POD), Sex Differences
- 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 |
|---|---|---|
| Female | Female patients aged 65 years or above with scheduled non-cardiac surgery with expected surgery duration ≥ 2 hours under either general or spinal anesthesia. | |
| Male | Male patients aged 65 years or above with scheduled non-cardiac surgery with expected surgery duration ≥ 2 hours under either general or spinal anesthesia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Delirium
The primary outcome is presence of delirium as assessed by the 4AT test. A 4AT score of 4 or above will be used for dichotomous assessment of the primary outcome presence of delirium. Participants will be assessed daily in the morning and the evening.
Measured: Starting on postoperative day (POD) 1 and continuing until POD 3, or discharge - whichever comes first.
Secondary outcomes (1)
Family Visits
The secondary outcome is hours spend being visited. Visits shall be self-reported by the visiting party. All visits regardless of relation to the participant (e.g., family, friends, or colleagues) shall be reported. Visits should be recorded in hourly intervals, regardless of the number of visitors present (e.g., two visitors for one hour, or one visitor for one hour, should counted as the same).
Measured: Starting on postoperative day (POD) 1 and continuing until POD 3, or discharge - whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start5 May 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
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.
- 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
- Prospective
- Enrolment
- 471 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Julian Rössler
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Julian Rössler, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07502391
- Sponsor's protocol ID
- 2025-02296
- Other IDs
- 2025
- Status last verified
- Mar 2026
- First submitted
- 25 Mar 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex-Dependent Risk of Postoperative Delirium and Mediating Effects of Family Visits: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07502391
- Acronym / sponsor ID
- 2025-02296
- Conditions
- Postoperative Delirium (POD), Sex Differences
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 471 participants (estimated)
- Lead sponsor
- Julian RösslerUniversity, hospital or other
- Study start
- 5 May 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 31 Mar 2026 (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.
Postoperative delirium is a common and serious complication after surgery, affecting 10-40% of older patients undergoing non-cardiac procedures. It is characterized by sudden changes in attention, awareness, and thinking that fluctuate throughout the day. Delirium is associated with longer hospital stays, higher mortality, worse long-term brain function, and substantially increased healthcare costs. While several risk factors are known, it remains unclear whether a patient's sex independently influences the risk of developing postoperative delirium, as existing studies have produced conflicting results and were often not designed to specifically examine sex differences.Family visitation is a promising non-drug approach to preventing delirium. Studies in intensive care patients have shown that those who receive family visits have a significantly lower risk of developing delirium. However, it is unknown whether men and women receive different amounts of family visits after surgery, and whether any such difference could help explain sex-based disparities in delirium risk. Given that traditional gender roles in caregiving persist, women - who often serve as primary caregivers in their families - may receive fewer visits when they themselves become patients.This prospective observational study led by the University of Zurich will enroll 471 patients aged 65 years or older undergoing non-cardiac surgery lasting at least 2 hours under general or spinal anesthesia. The primary aim is to determine whether female patients have a higher risk of developing postoperative delirium within three days after surgery compared to male patients. Delirium will be assessed twice daily using the 4 A's Test (4AT), a validated and standardized screening tool. The secondary aim is to evaluate whether female patients receive fewer family visits than male patients and whether any difference in visitation mediates the sex-dependent delirium risk. Family visits will be recorded using an anonymous sign-in sheet placed in the patient's room. The study does not involve any experimental interventions; all patients receive standard clinical care. Participation is voluntary, and withdrawal is possible at any time without affecting medical treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Female | – | –Female patients aged 65 years or above with scheduled non-cardiac surgery with expected surgery duration ≥ 2 hours under either general or spinal anesthesia. |
| Male | – | –Male patients aged 65 years or above with scheduled non-cardiac surgery with expected surgery duration ≥ 2 hours under either general or spinal anesthesia. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients aged 65 and older who are having noncardiac surgery
Key inclusion criteria (4 listed)
- Informed consent as documented by signature;
- ≥65 years of age;
- Scheduled non-cardiac surgery with expected surgery duration ≥ 2 hours;
- Under either general or spinal anesthesia.
Key exclusion criteria (4 listed)
- Known drug or alcohol abuse;
- Requirement for postoperative ventilation;
- Current participation in another study with an investigational drug;
- Inability to complete the study assessments.
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
Postoperative Delirium
Time frame: Starting on postoperative day (POD) 1 and continuing until POD 3, or discharge - whichever comes first.
The primary outcome is presence of delirium as assessed by the 4AT test. A 4AT score of 4 or above will be used for dichotomous assessment of the primary outcome presence of delirium. Participants will be assessed daily in the morning and the evening.
1 secondary outcome
Family Visits
Time frame: Starting on postoperative day (POD) 1 and continuing until POD 3, or discharge - whichever comes first
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
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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.
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) and Sex Differences, run by Julian Rössler at 1 site in Switzerland.
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 4 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: looking for participants now, as of the sponsor's last update on 1 Jun 2026. 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Delirium (time frame: Starting on postoperative day (POD) 1 and continuing until POD 3, or discharge - whichever comes first.). 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 1 Jun 2026.