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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01839227
Recruitment Status : Completed
First Posted : April 24, 2013
Last Update Posted : January 28, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Elderly Patients Undergoing Spinal Surgery Other: Neurologic and neuropsychologic tests Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Study Start Date : November 2012
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Experimental: regional cerebral oxygen saturation Other: Neurologic 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.

Primary Outcome Measures :
  1. K-MMSE [ Time Frame: 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 :
  1. visuomotor test(D-LOTCA battery) [ Time Frame: 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

  2. Regional cerebral oxymetry monitoring [ Time Frame: 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)

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Ages Eligible for Study:   65 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01839227

Korea, Republic of
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University


Responsible Party: Yonsei University Identifier: NCT01839227     History of Changes
Other Study ID Numbers: 1-2012-0039
First Posted: April 24, 2013    Key Record Dates
Last Update Posted: January 28, 2015
Last Verified: January 2015

Keywords provided by Yonsei University:
Post-operative cognitive dysfunction
regional cerebral oxygen saturation

Additional relevant MeSH terms:
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders