Completed

NCT Number: NCT01839227

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

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.

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Key information

Conditions

Elderly Patients Undergoing Spinal Surgery

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Neurologic and neuropsychologic tests

Other

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 outcomes

K-MMSE

Time frame: change of K-MMSE from baseine to 1 month
- 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)
- Intraoperative

Secondary outcomes

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
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)

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Apr 24, 2013
Registry last updated: Jan 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.