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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01839227
Enrollment
87
Registered
2013-04-24
Start date
2012-11-30
Completion date
2014-07-31
Last updated
2015-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elderly Patients Undergoing Spinal Surgery

Keywords

Post-operative cognitive dysfunction, regional cerebral oxygen saturation, elderly

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.

Interventions

OTHERNeurologic and neuropsychologic tests

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.

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
K-MMSEchange of K-MMSE from baseine to 1 month1. 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

MeasureTime frameDescription
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 monitoringmeasuring 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)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026