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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Johns Hopkins University.
Recruitment status was  Recruiting
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

February 16, 2012
April 9, 2012
March 2012
March 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
Not Provided
Not Provided
 
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
Not Provided
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
April 2014
March 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
No
Contact: Charles Brown, MD 410-955-0994 cbrown12@jhmi.edu
Contact: Mirinda Anderson White, RN, BSN, MS 410-955-6488 mander47@jhmi.edu
United States
 
NCT01574950
NA_00051796
No
Charles Brown, MD, Johns Hopkins University
Johns Hopkins University
Not Provided
Principal Investigator: Charles Brown, MD The Johns Hopkins University
Johns Hopkins University
April 2012

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