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 currently recruiting participants.
Verified October 2013 by Johns Hopkins University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Frederick Sieber, M.D., Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00590707
First received: December 28, 2007
Last updated: October 22, 2013
Last verified: October 2013

December 28, 2007
October 22, 2013
January 2005
January 2015   (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: Maintenance of level of awareness by use of a BIS monitor & the OASS.
    The level of awareness in this arm, as measured by the BIS score, will be kept at 50-60.
    Other Names:
    • BIS
    • BIS Monitor
    • Bi-Spectral Analysis Monitor
  • Device: Maintenance of level of awareness by use of a BIS monitor and the OASS.
    The level of awareness in this arm, as measured by the BIS score, will be kept at 70-80.
    Other Names:
    • BIS
    • BIS Monitor
    • Bi-Spectral Analysis Monitor
  • Active Comparator: 1
    Patients randomly assigned to this arm will receive enough sedative drugs to keep their level of awareness during the hip fracture repair at a BIS score of 50-60. This is the "deeper sedation" arm.
    Intervention: Device: Maintenance of level of awareness by use of a BIS monitor & the OASS.
  • Active Comparator: 2
    Patients randomly assigned to this arm will receive enough sedative drugs to keep their level of awareness during the hip fracture repair at a BIS score of 70-80. This is the "moderate sedation" arm.
    Intervention: Device: Maintenance of level of awareness by use of a BIS monitor and the OASS.
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.
 
Recruiting
210
December 2015
January 2015   (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 COPD;
  • has severe 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
No
Contact: Frederick E. Sieber, MD 410-550-0942 fsieber1@jhmi.edu
Contact: Michael D. Sklar, MA 410-550-1542 msklar1@jhmi.edu
United States
 
NCT00590707
NA_00041873, ACCM Delirium 3
Yes
Frederick Sieber, M.D., Johns Hopkins University
Johns Hopkins University
National Institutes of Health (NIH)
Principal Investigator: Frederick E. Sieber, MD Dept. of Anesthesiology and Critical Care Medicine, School of Medicine, The Johns Hopkins University
Johns Hopkins University
October 2013

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