Postoperative Delirium in Elder Patients After Spine Surgery Clinical Trial
| Verified date | March 2016 |
| Source | Yonsei University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Korea: Institutional Review Board |
| Study type | Observational |
Postoperative delirium is an important problem in patients undergoing major surgery. The incidence of delirium was 12.5% in the patients over 70 years old undergoing spine surgery. A study shows that a low preoperative regional cerebral oxygen saturation (rSO2) is associated with postoperative delirium after on-pump cardiac surgery. This same perturbation likely also increases the risk for postoperative delirium after spine surgery, although there are little data that have evaluated this hypothesis. Therefore, this observational study was designed to explore the relationship between perioperative rSO2 and the delirium in elderly patients undergoing spine surgery.
| Status | Completed |
| Enrollment | 109 |
| Est. completion date | November 2015 |
| Est. primary completion date | November 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 60 Years to 90 Years |
| Eligibility |
Inclusion Criteria: 1. Patients in the study will be 60 or older undergoing elective major spine surgery (expected operative time is more than 2 hrs). 2. Patients who can do the mini-mental state examination (MMSE), Confusion Assessment Method for the ICU (CAM-ICU) and Intensive Care Delirium Screening Checklist (ICDSC). 3. Patients who understand the nature of the study and are willing to sign the consent form Exclusion Criteria: 1. Emergency surgery 2. Patients diagnosed with neurocognitive disorders or psychiatric diseases, thus, cannot check MMSE or communicate with other people (e.g. Alzheimer's dementia, alcohol abuse) 3. Patients diagnosed with cerebrovascular disorders (e.g. stroke, atherosclerotic stenosis of carotid artery, TIA) 4. Patients who cannot be followed up until 2 days after surgery |
Observational Model: Case Control, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Yonsei University |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | the predictive power of periopertiver rSO2 regarding postoperative delirium | The presence and severity of delirium were assessed with Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) once a day. (1 day preopertive, 2 days postoperative.) The investigators plan to evaluate whether periopertive rSO2 can predict postoperative delirium in elder patients after spine surgery and to assess the predictive power of periopertiver rSO2 regarding postoperative delirium. Perioperative rSO2 was observed during surgery (an expected average of 2~3 hours). | up to 2days postoperative | No |