Post-Operative Delirium in Elderly Surgical Patients (STRIDE)

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

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.

• Hip Fractures
• Delirium

• Device: Maintenance of level of awareness by use of a BIS monitor & the OASS.
  The level of awareness in this arm, as measured by the BIS score, will be kept at 50-60.
  Other Names:

  • BIS
  • BIS Monitor
  • Bi-Spectral Analysis Monitor
• Device: Maintenance of level of awareness by use of a BIS monitor and the OASS.
  The level of awareness in this arm, as measured by the BIS score, will be kept at 70-80.
  Other Names:

  • BIS
  • BIS Monitor
  • Bi-Spectral Analysis Monitor

• Active Comparator: 1
  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.
  Intervention: Device: Maintenance of level of awareness by use of a BIS monitor & the OASS.
• Active Comparator: 2
  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.
  Intervention: Device: Maintenance of level of awareness by use of a BIS monitor and the OASS.

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 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