Clinical trial NCT00590707: Post-Operative Delirium in Elderly Surgical Patients
Official title: A Strategy to Reduce the Incidence of Post-Operative Delirium in Elderly Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fractures
Delirium
Keywords: Hip fractures
Femoral neck fractures
Trochanteric fractures
Intertrochanteric fractures
Subtrochanteric fractures
Delirium
Confusion
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2008-01-11
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This research is being done to see what effects sedative drugs during surgery have on peoples' thinking processes after they wake up.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With the Presence of Delirium as Assessed by the Confusion Assessment Method
timeFrame: Postoperative days up to hospital discharge
Secondary outcomes:
measure: Change in Functional Status
timeFrame: 12 months post-operative
measure: Mortality
timeFrame: 12 months post-operative
measure: Number of Participants With the Presence of Delirium at 1 Month as Assessed by the Confusion Assessment Method
timeFrame: 1 month (30 days) post-intervention
measure: Clinical Dementia Rating Sum of Boxes (CDR-SOB) Score
timeFrame: 12 months post-operative
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: The Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Dept. of Anesthesiology and Critical Care Medicine, School of Medicine, The Johns Hopkins University
name: Frederick E. Sieber, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sieber F, Neufeld KJ, Gottschalk A, Bigelow GE, Oh ES, Rosenberg PB, Mears SC, Stewart KJ, Ouanes JP, Jaberi M, Hasenboehler EA, Wang NY. Depth of sedation as an interventional target to reduce postoperative delirium: mortality and functional outcomes of the Strategy to Reduce the Incidence of Postoperative Delirium in Elderly Patients randomised clinical trial. Br J Anaesth. 2019 Apr;122(4):480-489. doi: 10.1016/j.bja.2018.12.021. Epub 2019 Feb 4.
citation: Sieber FE, Neufeld KJ, Gottschalk A, Bigelow GE, Oh ES, Rosenberg PB, Mears SC, Stewart KJ, Ouanes JP, Jaberi M, Hasenboehler EA, Li T, Wang NY. Effect of Depth of Sedation in Older Patients Undergoing Hip Fracture Repair on Postoperative Delirium: The STRIDE Randomized Clinical Trial. JAMA Surg. 2018 Nov 1;153(11):987-995. doi: 10.1001/jamasurg.2018.2602.
citation: 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.