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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01574950
First Posted: April 10, 2012
Last Update Posted: October 26, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Charles Brown, MD, Johns Hopkins University
  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:


Further study details as provided by Charles Brown, MD, 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 ]

Secondary Outcome Measures:
  • 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

Enrollment: 99
Study Start Date: March 2012
Study Completion Date: June 2014
Primary Completion Date: June 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

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Ages Eligible for Study:   70 Years and older   (Senior)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

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


Locations
United States, Maryland
The Johns Hopkins University
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Charles Brown, MD The Johns Hopkins University
  More Information

Responsible Party: Charles Brown, MD, Principal Investigator, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01574950     History of Changes
Other Study ID Numbers: NA_00051796
First Submitted: February 16, 2012
First Posted: April 10, 2012
Last Update Posted: October 26, 2015
Last Verified: October 2015

Keywords provided by Charles Brown, MD, Johns Hopkins University:
Delirium

Additional relevant MeSH terms:
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders