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Sponsored by: |
Johns Hopkins University |
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Information provided by: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT00590707 |
This research is being done to see what effects sedative drugs during surgery have on peoples' thinking processes after they wake up.
Condition | Intervention |
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Hip Fractures Delirium |
Device: Maintenance of level of awareness by use of a BIS monitor. |
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 |
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 |
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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.
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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.
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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.
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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.
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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.
Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Khwaja J. Zakriya, MD | 410-550-0942 | kzakriya@jhmi.edu |
Contact: Mary-Rita E. Blute, MS | 410-55-9872 | mblute1@jhmi.edu |
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 |
Principal Investigator: | Khwaja J. Zakriya, MD | Dept. of Anesthesiology and Critical Care Medicine, School of Medicine, The Johns Hopkins University |
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 |
Hip fractures Femoral neck fractures Trochanteric fractures Intertrochanteric fractures |
Subtrochanteric fractures Delirium Confusion |
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 |
Nervous System Diseases Hip Injuries |