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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01839227
First received: April 16, 2013
Last updated: April 21, 2013
Last verified: April 2013
  Purpose

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 Intervention
Strabismus
Other: Neurologic and neuropsychologic tests

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • K-MMSE [ Time Frame: change of K-MMSE from baseine to 1 month ] [ Designated as safety issue: No ]
    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:
  • visuomotor test(D-LOTCA battery) [ Time Frame: measuring for visuomotor test during baseline and 1 month ] [ Designated as safety issue: No ]

    :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 [ Time Frame: measuring for Regional cerebral oxymetry monitoring during baseline and 1 month ] [ Designated as safety issue: No ]
    • 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)


Estimated Enrollment: 93
Study Start Date: November 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


  Eligibility

Ages Eligible for Study:   65 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01839227

Contacts
Contact: Jae Kwang Shim, MD 82-2-2227-4965 aneshim@yuhs.ac

Locations
Korea, Republic of
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Jae Kwang Shim, MD    82-2-2227-4965    aneshim@yuhs.ac   
Sponsors and Collaborators
Yonsei University
  More Information

Publications:
Besch PK, Bermes EW Jr, McDonald HJ. Report of the second conference on education in clinical chemistry. Clin Chem. 1976 Apr;22(4):541-9.

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01839227     History of Changes
Other Study ID Numbers: 1-2012-0039
Study First Received: April 16, 2013
Last Updated: April 21, 2013
Health Authority: Korea: Institutional Review Board

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

Additional relevant MeSH terms:
Strabismus
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases

ClinicalTrials.gov processed this record on August 25, 2014