CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 87 enrolled
Drug / intervention
Neurologic and neuropsychologic testsother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01839227
NCT01839227N/ACompleted

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

Yonsei University·interventional·Posted Apr 24, 2013·Updated Jan 28, 2015

In Brief

A clinical study evaluating Neurologic and neuropsychologic tests for Elderly Patients Undergoing Spinal Surgery. Completed, enrolled 87 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSouth Korea
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 24, 2013
Enrollment StartNov 1, 2012
Primary CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 13.2 years ago

Interventions

Neurologic and neuropsychologic testsother

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.