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Impact of Impaired Cerebral Autoregulation on Postoperative Delirium in Elderly Patients Undergoing Spine Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Charles Brown, MD, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01574950
First received: February 16, 2012
Last updated: October 23, 2015
Last verified: October 2015

February 16, 2012
October 23, 2015
March 2012
June 2014   (final data collection date for primary outcome measure)
Incidence of post-operative delirium in elderly patients undergoing spine surgery at Johns Hopkins Hospital [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01574950 on ClinicalTrials.gov Archive Site
Severity of postoperative delirium, using Delirium Rating Scale-Revised-1998, in elderly patients undergoing spine surgery. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
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Impact of Impaired Cerebral Autoregulation on Postoperative Delirium in Elderly Patients Undergoing Spine Surgery
The Impact of Impaired Cerebral Autoregulation on the Development of Postoperative Delirium in Elderly Patients Undergoing Spine Surgery
Delirium (confusion) after surgery is common and associated with a longer hospitl stay and increased hopsital cost. There is very little information available about how often delirium occurs and the complications associated with it. Elderly patients are at high risk for delirium after surgery. This research is being done to measure how often delirium after spine surgery occurs and to see if there are ways to predict if delirium will develop. The results from this study will provide important information on a possible mechanism and predictor of delirium.
Delirium (confusion) after surgery is common and associated with a longer hospitl stay and increased hopsital cost. This research is being done to measure how often delirium after spine surgery occurs and to see if there are ways to predict if delirium will develop. We hypothesize that impaired cerebral autoregulation may be a possible mechanism for postoperative delirium. We will measure intraoperative cerebral autoregulation and assess the relationship with postoperative dleirium. The results from this study will provide important information on a possible mechanism and predictor of delirium.
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:
Blood samples
Probability Sample
The study population is male and female subjects age 70 years and older that are having spine surgery.
Delirium
Not Provided
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
99
June 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. ≥ 70 years old,
  2. Undergoing any lumbar spine surgery, posterior cervical spine surgery, or anterior cervical spine surgery > 2 levels

Exclusion Criteria:

  1. MMSE < 15
  2. Delirium at baseline
  3. Inability to speak and understand English
  4. Severe hearing impairment, resulting in inability to converse.
  5. Planned use of intraoperative ketamine
  6. Planned use of intraoperative remifentanil, except for airway management pre-incision.
  7. Arterial catheter not planned to be inserted
Both
70 Years and older   (Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01574950
NA_00051796
No
Not Provided
Not Provided
Charles Brown, MD, Johns Hopkins University
Johns Hopkins University
Not Provided
Principal Investigator: Charles Brown, MD The Johns Hopkins University
Johns Hopkins University
October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP