Trial record 1 of 1 for:    Postoperative Delirium in Elderly Patients AND Frederick Sieber
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Post-Operative Delirium in Elderly Surgical Patients (STRIDE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Frederick Sieber, M.D., Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00590707
First received: December 28, 2007
Last updated: June 6, 2016
Last verified: June 2016

December 28, 2007
June 6, 2016
January 2005
May 2017   (final data collection date for primary outcome measure)
Presence of delirium [ Time Frame: Postoperative days 1-5; 1 mon. after surgery; & 1 yr. after surgery ] [ Designated as safety issue: No ]
Memory/thinking testing
Presence of delirium 2, 45, and 90 days after surgery [ Time Frame: 90 days after surgery ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00590707 on ClinicalTrials.gov Archive Site
Change in functional status [ Time Frame: 1 mon. & 1 yr. after surgery ] [ Designated as safety issue: No ]
Ability to perform Activities of Daily Living; strength and walking testing
Change in functional status (ADLs, IADLs) at 2, 45, and 90 days after surgery [ Time Frame: 90 days after surgery ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Post-Operative Delirium in Elderly Surgical Patients
A Strategy to Reduce the Incidence of Post-Operative Delirium in Elderly Patients
This research is being done to see what effects sedative drugs during surgery have on peoples' thinking processes after they wake up.
We give sedative drugs to patients having spinal anesthesia so they are "asleep" (sedated) while we are fixing their broken hips. The spinal anesthesia provides pain relief at the site of surgery, while the sedative drugs keep people "asleep" during the procedure. We want to find out whether the amount of sedation we give might (1) make patients be confused when they wake up or (2) have anything to do with how well patients can do their ordinary daily routines a few months after their surgery.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
  • Hip Fractures
  • Delirium
  • Device: Deeper sedation
    The depth of sedation, as measured by the Bispectral index (BIS) score and the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), will be maintained at a BIS value of 50-60 and/or an OAA/S score of 0.
    Other Names:
    • BIS
    • BIS Monitor
    • Bi-Spectral Analysis Monitor
  • Device: Moderate sedation
    The depth of sedation, as measured by the Bispectral index (BIS) score and the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), will be maintained at a BIS value of 70-80 and/or an OAA/S score of 4-5.
    Other Names:
    • BIS
    • BIS Monitor
    • Bi-Spectral Analysis Monitor
  • Active Comparator: Deeper sedation
    Patients randomly assigned to this arm will receive enough sedative drugs to keep their level of awareness during the hip fracture repair at a Bispectral index (BIS) score of 50-60. This is the "deeper sedation" arm.
    Intervention: Device: Deeper sedation
  • Active Comparator: Moderate sedation
    Patients randomly assigned to this arm will receive enough sedative drugs to keep their level of awareness during the hip fracture repair at a Bispectral index (BIS) score of 70-80. This is the "moderate sedation" arm.
    Intervention: Device: Moderate sedation
Sieber FE, Zakriya KJ, Gottschalk A, Blute MR, Lee HB, Rosenberg PB, Mears SC. Sedation depth during spinal anesthesia and the development of postoperative delirium in elderly patients undergoing hip fracture repair. Mayo Clin Proc. 2010 Jan;85(1):18-26. doi: 10.4065/mcp.2009.0469. Erratum in: Mayo Clin Proc. 2010 Apr;85(4):400. Dosage error in article text.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
May 2017
May 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • is 65 years of age or older at admission;
  • has surgical treatment of a traumatic hip fracture;
  • has participating surgeon;
  • has Mini-Mental Status Exam score of 15 or higher;
  • able to read/write/speak/hear/understand English;
  • gives informed consent;
  • receives spinal anesthesia

Exclusion Criteria:

  • receives general anesthesia;
  • does not write/write/speak/hear/understand English;
  • has severe chronic obstructive pulmonary disease (COPD);
  • has severe congestive heart failure (CHF);
  • has Mini-Mental Status Exam score less than 15;
  • declines to give informed consent;
  • age less than 65 years at admission;
  • attending surgeon does not participate in study
Both
65 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00590707
NA_00041873, ACCM Delirium 3, R01AG033615
Yes
Not Provided
Not Provided
Frederick Sieber, M.D., Johns Hopkins University
Johns Hopkins University
National Institute on Aging (NIA)
Principal Investigator: Frederick E. Sieber, MD Dept. of Anesthesiology and Critical Care Medicine, School of Medicine, The Johns Hopkins University
Johns Hopkins University
June 2016

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