Overview

This trial is active, not recruiting.

Conditions hip fractures, delirium
Treatments deeper sedation, moderate sedation
Sponsor Johns Hopkins University
Collaborator National Institute on Aging (NIA)
Start date January 2005
End date May 2017
Trial size 200 participants
Trial identifier NCT00590707, ACCM Delirium 3, NA_00041873, R01AG033615

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, outcomes assessor)
Primary purpose prevention
Arm
(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 Bispectral index (BIS) score of 50-60. This is the "deeper sedation" arm.
deeper sedation BIS
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.
(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 Bispectral index (BIS) score of 70-80. This is the "moderate sedation" arm.
moderate sedation BIS
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.

Primary Outcomes

Measure
Presence of delirium
time frame: Postoperative days 1-5; 1 mon. after surgery; & 1 yr. after surgery

Secondary Outcomes

Measure
Change in functional status
time frame: 1 mon. & 1 yr. after surgery

Eligibility Criteria

Male or female participants at least 65 years old.

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

Additional Information

Official title A Strategy to Reduce the Incidence of Post-Operative Delirium in Elderly Patients
Principal investigator Frederick E. Sieber, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Johns Hopkins University.