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

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ClinicalTrials.gov Identifier: NCT01574950
Recruitment Status : Completed
First Posted : April 10, 2012
Last Update Posted : October 26, 2015
Sponsor:
Information provided by (Responsible Party):
Charles Brown, MD, Johns Hopkins University

Study Description
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Brief Summary:
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.

Condition or disease
Delirium

Detailed Description:
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.
Study Design
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Study Type : Observational
Actual Enrollment : 99 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Impact of Impaired Cerebral Autoregulation on the Development of Postoperative Delirium in Elderly Patients Undergoing Spine Surgery
Study Start Date : March 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Incidence of post-operative delirium in elderly patients undergoing spine surgery at Johns Hopkins Hospital [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Severity of postoperative delirium, using Delirium Rating Scale-Revised-1998, in elderly patients undergoing spine surgery. [ Time Frame: 24 months ]

Biospecimen Retention:   Samples Without DNA
Blood samples

Eligibility Criteria
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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study population is male and female subjects age 70 years and older that are having spine surgery.
Criteria

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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01574950


Locations
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United States, Maryland
The Johns Hopkins University
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Charles Brown, MD The Johns Hopkins University
More Information
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Responsible Party: Charles Brown, MD, Principal Investigator, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01574950    
Other Study ID Numbers: NA_00051796
First Posted: April 10, 2012    Key Record Dates
Last Update Posted: October 26, 2015
Last Verified: October 2015
Keywords provided by Charles Brown, MD, Johns Hopkins University:
Delirium
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
 Nervous System Diseases
Neurocognitive Disorders
Mental Disorders