Delirium - PostoperativeNCT07463586
Cerebral Oxygen Consumption Response to Increased Oxygen Supply and Postoperative Delirium in Older Surgical Patients
An observational study of Delirium - Postoperative and Cerebral Oxygenation, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
The goal of this observational study is to learn whether the brain's ability to use oxygen during surgery is associated with postoperative delirium in adults aged 65 years and older undergoing general anesthesia. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Delirium - Postoperative, Cerebral Oxygenation
- What is being tested?
- Intraoperative Cerebral Oxygen Utilization Assessment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Mar 2026to May 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
- Older adult
Study population: Participants will be recruited from patients scheduled for elective laparoscopic surgery at Seoul National University Bundang Hospital, a tertiary academic medical center in the Republic of Korea. Eligible patients will be identified during routine preoperative evaluation and approached for study participation prior to surgery.
Who may be able to join
- Patients undergoing elective laparoscopic surgery under general anesthesia
- Age 65 years or older
Who cannot join
- Diagnosis of dementia or presence of delirium before surgery
- Loss of capacity to provide informed consent
- Moderate or severe cerebrovascular stenosis diagnosed before surgery
- Moderate or severe obstructive or restrictive pulmonary dysfunction identified on preoperative pulmonary function testing
- Requirement for supplemental oxygen therapy before surgery
- History of neurological disorders (e.g., Parkinson's disease, stroke) or prior brain surgery
Show all 12Show fewer
- Severe hepatic dysfunction (AST or ALT > 120 IU/L)
- Severe renal dysfunction (estimated GFR < 15 mL/min/1.73 m²)
- Persistent severe hemodynamic instability (mean arterial pressure < 60 mmHg)
- Skin conditions preventing placement of the forehead fNIRS sensor
- Combined surgical procedures performed concurrently
- Planned postoperative admission to the intensive care unit
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Soowon Lee, MD, PhD, +82-31-787-7499, soowonlee@snubh.org
About this study
Official title: Association Between Cerebral Oxygen Consumption Responsiveness to Increased Oxygen Supply and Postoperative Delirium: A Prospective Observational Study Using Functional Near-Infrared Spectroscopy
The goal of this observational study is to learn whether the brain's ability to use oxygen during surgery is associated with postoperative delirium in adults aged 65 years and older undergoing general anesthesia.
The main question it aims to answer is:
- Does reduced cerebral oxygen consumption responsiveness during surgery increase the risk of postoperative delirium in older patients?
Participants who are undergoing elective laparoscopic surgery under general anesthesia as part of their routine medical care will have brain oxygen levels measured during surgery using a non-invasive forehead sensor, and will be assessed for delirium for up to three days after surgery.
- Conditions
- Delirium - Postoperative, Cerebral Oxygenation
- Being tested
- Intraoperative Cerebral Oxygen Utilization Assessment
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative Cerebral Oxygen Utilization AssessmentOther
Cerebral oxygenation will be monitored intraoperatively using a non-invasive forehead sensor based on functional near-infrared spectroscopy technology. During general anesthesia, the fraction of inspired oxygen (FiO₂) may be temporarily adjusted within the standard clinical range used in routine anesthesia care to evaluate the brain's oxygen utilization response. No experimental oxygen levels or additional therapeutic interventions will be administered beyond standard clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Older patients undergoing elective laparoscopic surgery | Adults aged 65 years and older undergoing elective laparoscopic surgery under general anesthesia will be prospectively observed. During surgery, cerebral oxygen levels will be measured using a non-invasive forehead sensor to assess the brain's oxygen utilization response within the range of routine anesthesia care. Participants will be followed for up to three days after surgery to evaluate the occurrence of postoperative delirium. Receives: Other: Intraoperative Cerebral Oxygen Utilization Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postoperative Delirium
Postoperative delirium diagnosed using 3D-CAM conducted in the post-anesthesia care unit and hospital ward. Delirium will be defined as at least one positive assessment during the first three postoperative days.
Measured: Up to 3 days after surgery
Secondary outcomes (1)
Intraoperative Cerebral Oxygen Utilization Response (ΔHbO-HbR)
Change in the difference between oxygenated hemoglobin (HbO) and deoxygenated hemoglobin (HbR), calculated as Δ(HbO-HbR), measured intraoperatively using functional near-infrared spectroscopy during variations in inspired oxygen concentration within the clinically applied range.
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start11 Mar 2026
- Primary completionMar 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium - PostoperativeStudies 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07463586
- Sponsor's protocol ID
- B-2602-1024-002
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Cerebral Oxygen Consumption Responsiveness to Increased Oxygen Supply and Postoperative Delirium: A Prospective Observational Study Using Functional Near-Infrared Spectroscopy
- ClinicalTrials.gov ID
- NCT07463586
- Acronym / sponsor ID
- B-2602-1024-002
- Conditions
- Delirium - Postoperative, Cerebral Oxygenation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 11 Mar 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 11 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.
The goal of this observational study is to learn whether the brain's ability to use oxygen during surgery is associated with postoperative delirium in adults aged 65 years and older undergoing general anesthesia.
The main question it aims to answer is:
- Does reduced cerebral oxygen consumption responsiveness during surgery increase the risk of postoperative delirium in older patients?
Participants who are undergoing elective laparoscopic surgery under general anesthesia as part of their routine medical care will have brain oxygen levels measured during surgery using a non-invasive forehead sensor, and will be assessed for delirium for up to three days after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Older patients undergoing elective laparoscopic surgery | – | Other: Intraoperative Cerebral Oxygen Utilization AssessmentAdults aged 65 years and older undergoing elective laparoscopic surgery under general anesthesia will be prospectively observed. During surgery, cerebral oxygen levels will be measured using a non-invasive forehead sensor to assess the brain's oxygen utilization response within the range of routine anesthesia care. Participants will be followed for up to three days after surgery to evaluate the occurrence of postoperative delirium. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- Participants will be recruited from patients scheduled for elective laparoscopic surgery at Seoul National University Bundang Hospital, a tertiary academic medical center in the Republic of Korea. Eligible patients will be identified during routine preoperative evaluation and approached for study participation prior to surgery.
Key inclusion criteria (2 listed)
- Patients undergoing elective laparoscopic surgery under general anesthesia
- Age 65 years or older
Key exclusion criteria (12 listed)
- Diagnosis of dementia or presence of delirium before surgery
- Loss of capacity to provide informed consent
- Moderate or severe cerebrovascular stenosis diagnosed before surgery
- Moderate or severe obstructive or restrictive pulmonary dysfunction identified on preoperative pulmonary function testing
- Requirement for supplemental oxygen therapy before surgery
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 |
|---|---|---|
| Intraoperative Cerebral Oxygen Utilization AssessmentCerebral oxygenation will be monitored intraoperatively using a non-invasive forehead sensor based on functional near-infrared spectroscopy technology. During general anesthesia, the fraction of inspired oxygen (FiO₂) may be temporarily adjusted within the standard clinical range used in routine anesthesia care to evaluate the brain's oxygen utilization response. No experimental oxygen levels or additional therapeutic interventions will be administered beyond standard clinical practice. | Other | Older patients undergoing elective laparoscopic surgery |
Primary outcome
Incidence of Postoperative Delirium
Time frame: Up to 3 days after surgery
Postoperative delirium diagnosed using 3D-CAM conducted in the post-anesthesia care unit and hospital ward. Delirium will be defined as at least one positive assessment during the first three postoperative days.
1 secondary outcome
Intraoperative Cerebral Oxygen Utilization Response (ΔHbO-HbR)
Time frame: During surgery
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 2 Apr 2026.
- Individual participant dataSharing planned: Yes
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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 Delirium - Postoperative and Cerebral Oxygenation, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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 2 inclusion and 12 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 2 Apr 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 South Korea. 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?
Contact Soowon Lee, MD, PhD (+82-31-787-7499, soowonlee@snubh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Delirium (time frame: Up to 3 days after surgery). 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 2 Apr 2026; AzTrials last refreshed its copy on 1 Nov 2026.