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Clinical Trials/NCT02331953
NCT02331953
Completed
Not Applicable

Predictors of Postoperative Delirium in Elder Patients After Spine Surgery: Regional Cerebral Oxygen Saturation

Yonsei University1 site in 1 country109 target enrollmentSeptember 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Delirium in Elder Patients After Spine Surgery
Sponsor
Yonsei University
Enrollment
109
Locations
1
Primary Endpoint
the predictive power of periopertiver rSO2 regarding postoperative delirium
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
September 2014
End Date
November 2015
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients in the study will be 60 or older undergoing elective major spine surgery (expected operative time is more than 2 hrs).
  • 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).
  • Patients who understand the nature of the study and are willing to sign the consent form

Exclusion Criteria

  • Emergency surgery
  • Patients diagnosed with neurocognitive disorders or psychiatric diseases, thus, cannot check MMSE or communicate with other people (e.g. Alzheimer's dementia, alcohol abuse)
  • Patients diagnosed with cerebrovascular disorders (e.g. stroke, atherosclerotic stenosis of carotid artery, TIA)
  • Patients who cannot be followed up until 2 days after surgery

Outcomes

Primary Outcomes

the predictive power of periopertiver rSO2 regarding postoperative delirium

Time Frame: up to 2days postoperative

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).

Study Sites (1)

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