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

NCT ID: NCT02331953

Last Updated: 2016-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

109 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Delirium in Elder Patients After Spine Surgery

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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delirium group

the patients with delirium after spine surgery

No interventions assigned to this group

no delirium group

the patients without delirium after spine surgery

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2014-0606

Identifier Type: -

Identifier Source: org_study_id

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