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

This study is currently recruiting participants.
Verified April 2012 by Johns Hopkins University
Sponsor:
Information provided by (Responsible Party):
Charles Brown, MD, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01574950
First received: February 16, 2012
Last updated: April 9, 2012
Last verified: April 2012
History of Changes
  Purpose

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
Delirium

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

MedlinePlus related topics: Delirium
U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Incidence of post-operative delirium in elderly patients undergoing spine surgery at Johns Hopkins Hospital [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA

Blood samples


Estimated Enrollment: 120
Study Start Date: March 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01574950

Contacts
Contact: Charles Brown, MD 410-955-0994 cbrown12@jhmi.edu
Contact: Mirinda Anderson White, RN, BSN, MS 410-955-6488 mander47@jhmi.edu

Locations
United States, Maryland
The Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Charles Brown, MD     410-955-0994     cbrown12@jhmi.edu    
Contact: Mirinda Anderson, RN     410-955-6488     mander47@jhmi.edu    
Principal Investigator: Charles Brown, MD            
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Charles Brown, MD The Johns Hopkins University
  More Information

No publications provided

Responsible Party: Charles Brown, MD, Principal Investigator, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01574950     History of Changes
Other Study ID Numbers: NA_00051796
Study First Received: February 16, 2012
Last Updated: April 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Delirium

Additional relevant MeSH terms:
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
 Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013