Post-Operative Delirium in Elderly Surgical Patients

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2017-05-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Hip Fractures Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Deeper sedation

Patients randomly assigned to this arm will receive enough sedative drugs to keep their level of awareness during the hip fracture repair, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), at an OAA/S score of 0. This is the "deeper sedation" arm.

Group Type ACTIVE_COMPARATOR

Deeper sedation

Intervention Type DEVICE

The depth of sedation, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), will be maintained at an OAA/S score of 0.

Moderate sedation

Patients randomly assigned to this arm will receive enough sedative drugs to keep their level of awareness during the hip fracture repair, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), at an OAA/S score of 4-5. This is the "moderate sedation" arm.

Group Type ACTIVE_COMPARATOR

Moderate sedation

Intervention Type DEVICE

The depth of sedation, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), will be maintained at an OAA/S score of 4-5.

Interventions

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Deeper sedation

The depth of sedation, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), will be maintained at an OAA/S score of 0.

Intervention Type DEVICE

Moderate sedation

The depth of sedation, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), will be maintained at an OAA/S score of 4-5.

Intervention Type DEVICE

Other Intervention Names

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Observer's Assessment of Awareness/Sedation Scale (OAA/S) Observer's Assessment of Awareness/Sedation Scale (OAA/S)

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No