Cerebral Oxygen Consumption Response to Increased Oxygen Supply and Postoperative Delirium in Older Surgical Patients

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorSeoul National University Bundang Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients undergoing elective laparoscopic surgery under general anesthesia

Age 65 years or older

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Intraoperative Cerebral Oxygen Utilization Assessment

    Other intervention

    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.

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: Older patients undergoing elective laparoscopic surgery1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
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.

Time frame
During surgery

Other outcomes

1

Predictive Performance of ΔHbO-HbR for Postoperative Delirium

Predictive accuracy of intraoperative Δ(HbO-HbR) for postoperative delirium assessed using receiver operating characteristic (ROC) curve analysis. The area under the ROC curve (AUC) will be calculated to quantify discrimination.

Time frame
Up to 3 days after surgery

Sponsors and contacts

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