Sedation and Delirium in Elderly Hip Fracture Patients - Full Text View

Sponsored by:	Johns Hopkins University
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00590707

Purpose

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

Condition	Intervention
Hip Fractures Delirium	Device: Maintenance of level of awareness by use of a BIS monitor.

MedlinePlus related topics: Fractures Hip Injuries and Disorders Hip Replacement

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Depth of Sedation Affects Long-Term Functional Outcome and Post-Operative Delirium in Elderly Hip Fracture Patients

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:

Presence of delirium 2, 45, and 90 days after surgery [ Time Frame: 90 days after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	114
Study Start Date:	January 2005
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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.	Device: Maintenance of level of awareness by use of a BIS monitor. The level of awareness in this arm, as measured by the BIS score, will be kept at 50-60.
2: Active Comparator 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.	Device: Maintenance of level of awareness by use of a BIS monitor. The level of awareness in this arm, as measured by the BIS score, will be kept at 70-80.

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

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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 Satus Exam score of 15 or higher;
able to read/write/speak/understand English;
gives informed consent;
receives spinal anesthesia

Exclusion Criteria:

receives general anesthesia;
does not write/write/speak/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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00590707

Contacts

Contact: Khwaja J. Zakriya, MD	410-550-0942	kzakriya@jhmi.edu
Contact: Mary-Rita E. Blute, MS	410-55-9872	mblute1@jhmi.edu

Locations

United States, Maryland
The Johns Hopkins Bayview Medical Center	Recruiting
Baltimore, Maryland, United States, 21224
Sub-Investigator: Frederick E. Sieber, MD
Sub-Investigator: Mary-Rita E. Blute, MS
Sub-Investigator: Coletta Richards, MD
Sub-Investigator: Simon Mears, MD, PhD

Sponsors and Collaborators

Johns Hopkins University

Investigators

Principal Investigator:

Khwaja J. Zakriya, MD

Dept. of Anesthesiology and Critical Care Medicine, School of Medicine, The Johns Hopkins University

More Information

Responsible Party:	School of Medicine, The Johns Hopkins University ( Khwaja Javaid Zakriya )
Study ID Numbers:	04-12-29-01, ACCM Delirium 3
Study First Received:	December 28, 2007
Last Updated:	December 28, 2007
ClinicalTrials.gov Identifier:	NCT00590707
Health Authority:	United States: Institutional Review Board

Keywords provided by Johns Hopkins University:

Hip fractures
Femoral neck fractures
Trochanteric fractures
Intertrochanteric fractures

Subtrochanteric fractures
Delirium
Confusion

Study placed in the following topic categories:

Femoral Neck Fractures
Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin
Confusion
Cognition Disorders
Hip Fractures
Signs and Symptoms

Femoral Fractures
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Neurologic Manifestations
Leg Injuries
Dementia
Neurobehavioral Manifestations
Delirium

Additional relevant MeSH terms:

Nervous System Diseases
Hip Injuries

ClinicalTrials.gov processed this record on January 16, 2009