Post-operative Cognitive Dysfunction and the Change of Regional Cerebral Oxygen Saturation in Elderly Patients Undergoing Spinal Surgery
Primary Purpose
Elderly Patients Undergoing Spinal Surgery
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Neurologic and neuropsychologic tests
Sponsored by
About this trial
This is an interventional screening trial for Elderly Patients Undergoing Spinal Surgery focused on measuring Post-operative cognitive dysfunction, regional cerebral oxygen saturation, elderly
Eligibility Criteria
Inclusion Criteria:
- the patient undergoing the lumbar spine surgery in severance hospital
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.
Sites / Locations
- Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
regional cerebral oxygen saturation
Arm Description
Outcomes
Primary Outcome Measures
K-MMSE
preoperative neuropsychological evaluation (the day before the surgery)
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
visuomotor test(D-LOTCA battery)
: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
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01839227
Brief Title
Post-operative Cognitive Dysfunction and the Change of Regional Cerebral Oxygen Saturation in Elderly Patients Undergoing Spinal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elderly Patients Undergoing Spinal Surgery
Keywords
Post-operative cognitive dysfunction, regional cerebral oxygen saturation, elderly
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
regional cerebral oxygen saturation
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Neurologic and neuropsychologic tests
Intervention Description
Cognitive functioning was assessed with the following test: Korean Mini-Mental State Examination (K-MMSE) and visuomotor test of D-LOTCA battery.
Regional cerebral oxygen saturation was continuously monitored using the INVOS 5100 (somatics,Troy, MI) with bifrontal placement of two sensors before the induction of the anesthesia until the end of operation.
Baseline rSO2 was defined as the average saturation value over a 1 min period before induction of general anesthesia, beginning approximately 3 min after the sensors were applied in supine position. After the induction, baseline prone rSO2 was defined over a 5min period after the change of position.
There is no intervention were made according to rSO2 values. Physiologic variables including BIS, PaCO2,PaO2, glucose, electrolyte, hematocrit, HR, MAP, and nasopharyngeal temperature were measured every 1 hours during the surgery.
Primary Outcome Measure Information:
Title
K-MMSE
Description
preoperative neuropsychological evaluation (the day before the surgery)
intraoperative rSO2 data monitoring
3-1. immediate postoperative neuropsychological evaluation (postoperative 4th~7th day)
3-2. remote postoperative neuropsychological evaluation (postoperative 1month)
4. Intraoperative
Time Frame
change of K-MMSE from baseine to 1 month
Secondary Outcome Measure Information:
Title
visuomotor test(D-LOTCA battery)
Description
:Visuomotor test (D-LOTCA battery)
Copy Geometric Forms
Two Dimensional Model
Pegboard Construction
Block Design(colored)
Reproduction of Puzzle
Drawing Clock
Time Frame
measuring for visuomotor test during baseline and 1 month
Title
Regional cerebral oxymetry monitoring
Description
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)
Time Frame
measuring for Regional cerebral oxymetry monitoring during baseline and 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
the patient undergoing the lumbar spine surgery in severance hospital
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.
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
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Post-operative Cognitive Dysfunction and the Change of Regional Cerebral Oxygen Saturation in Elderly Patients Undergoing Spinal Surgery
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