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Completed

NCT Number: NCT00590707

Post-Operative Delirium in Elderly Surgical Patients

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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Key information

Conditions

Hip Fractures Confusion Delirium Femoral Fractures Femoral Neck Fractures Fractures, Bone Hip Injuries Leg Injuries Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deeper sedation

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.

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

Moderate sedation

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.

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

Primary outcomes

  1. Number of Participants With the Presence of Delirium as Assessed by the Confusion Assessment Method

    Time frame: Postoperative days up to hospital discharge

    The presence of delirium is assessed by the confusion assessment method (CAM), during postoperative Day 1 to Day 5 or up to hospital discharge, whichever occurs first. The CAM consists of 4 features: 1-Onset, 2-Inattention, 3-Disorganized thinking, and 4-altered level of consciousness. The diagnosis of delirium by CAM is based on the presence of features 1 and 2, and either 3 or 4.

Secondary outcomes

  1. Change in Functional Status

    Time frame: 12 months post-operative

    Ability to perform Activities of Daily Living (ADL) using 6-point Katz activities of daily living scale, assessed at 12 months post-op. The range of the Katz activities of daily living scale is from 0-6, 0 is worse and 6 is best.

  2. Mortality

    Time frame: 12 months post-operative

    death occurring during follow-up period, in one year post-op.

  3. Number of Participants With the Presence of Delirium at 1 Month as Assessed by the Confusion Assessment Method

    Time frame: 1 month (30 days) post-intervention

    The presence of delirium is assessed by the confusion assessment method (CAM), after 1 month postoperative. The CAM consists of 4 features: 1-Onset, 2-Inattention, 3-Disorganized thinking, and 4-altered level of consciousness. The diagnosis of delirium by CAM is based on the presence of features 1 and 2, and either 3 or 4.

  4. Clinical Dementia Rating Sum of Boxes (CDR-SOB) Score

    Time frame: 12 months post-operative

    Clinical Dementia Rating consists of 6 domains ("boxes") of function: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Each domain ("box") is rated on a 5-point scale (0= no impairment, 0.5=questionable impairment, 1= mild impairment, 2= moderated impairment, 3= severe impairment. The CDR-SOB score is a sum of these ratings, for a total Sum of boxes ranging from 0-18, where 0=cognitively intact. Increasing sum of boxes score is associated with greater cognitive impairment.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

A Strategy to Reduce the Incidence of Post-Operative Delirium in Elderly Patients

Acronym: STRIDE

Important dates

Study start
2005
Primary completion
2017
Study completion
2017
First posted
Jan 11, 2008
Registry last updated
Jun 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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