Post-Operative Delirium in Elderly Surgical Patients (STRIDE)

Johns Hopkins University

Status: Completed

Conditions: Hip Fractures; Delirium

Treatments: Device: Moderate sedation; Device: Deeper sedation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00590707

ACCM Delirium 3

NA_00041873

R01AG033615 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups

Deeper sedation

Active Comparator group

Description:

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.

Treatment:

Device: Deeper sedation

Moderate sedation

Active Comparator group

Description:

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.

Treatment:

Device: Moderate sedation