Post-operative Cognitive Dysfunction and the Change of Regional Cerebral Oxygen Saturation in Elderly Patients Undergoing Spinal Surgery

Not Applicable

Completed

• Conditions: Elderly Patients Undergoing Spinal Surgery
• Interventions: Other: Neurologic and neuropsychologic tests

• Registration Number: NCT01839227
• Lead Sponsor: Yonsei University

Brief Summary

Post operative cognitive dysfunction (POCD) is a well-recognized complication of patients undergoing cardiac surgery. Previous studies reported near-infrared spectroscopy provides information on the occurrence of cerebral desaturation resulted in POCD. But evidence of POCD after general surgery has been lacking. Especially, the prone position is used primarily for surgical access to the posterior spine, if there is any significant lowering of the legs or tilt of the entire table, venous returns may be decrease or augmented accordingly. The purpose of this study was to examine the relationship between POCD and intra-operative cerebral oxygen saturation after spine surgery in elderly patients.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-04-16
• Study First Submitted QC: 2013-04-21
• Study First Posted: 2013-04-24
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-27
• Last Update Posted: 2015-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

Inclusion Criteria

• the patient undergoing the lumbar spine surgery in severance hospital

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Exclusion Criteria

• Patients who had previous cerebral disease, dementia, severe problems in hearing and understanding, or who were unable to provide informed consent were excluded.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
regional cerebral oxygen saturation	Neurologic and neuropsychologic tests	-

Primary Outcome Measures

Name	Time	Method
K-MMSE	change of K-MMSE from baseine to 1 month	1. preoperative neuropsychological evaluation (the day before the surgery); 2. intraoperative rSO2 data monitoring; 3-1. immediate postoperative neuropsychological evaluation (postoperative 4th\~7th day); 3-2. remote postoperative neuropsychological evaluation (postoperative 1month); 4. Intraoperative

Secondary Outcome Measures

Name	Time	Method
visuomotor test(D-LOTCA battery)	measuring for visuomotor test during baseline and 1 month	:Visuomotor test (D-LOTCA battery); * Copy Geometric Forms; * Two Dimensional Model; * Pegboard Construction; * Block Design(colored); * Reproduction of Puzzle; * Drawing Clock
Regional cerebral oxymetry monitoring	measuring for Regional cerebral oxymetry monitoring during baseline and 1 month	* Correlation between rSO2 and POCD; * The average, left and right absolute rSO2 values were collected every 30 seconds. rSO2 value was recorded as excel data.; * Absolute rSO2 value and AUT(area under the threshold) send beneath the absolute threshold limits of 40%, 50%, 60% and 20% under the baseline. AUT was calculated based on this formula: AUT (present)=AUT (past)+(rSO2 threshold-rSO2 value)×sample rate; * cutoff value of rSO2 predictive POCD; * Correlation of physical value affecting rSO2 and POCD (BIS, PaCO2,PaO2, glucose, electrolyte, hematocrit, HR, MAP, and nasopharyngeal temperature, intraoperative blood loss, amount of intake fluid, total dose of vasopressor)

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of