The purpose of this study is to evaluate the efficacy and safety of perioperative use of dexmedetomidine in the prevention of postoperative delirium in subjects undergoing surgery for fractured hip with general anesthesia.
Postoperative delirium is an acute decline in cognition and attention which is usually transient but when delirium persists it can impact cognitive function, morbidity and morality. There are no drugs that are currently approved to prevent the onset of delirium but dexmedetomidine has the potential to meet this unmet medical need. Hip fractures, unfortunately are frequent occurrences in the elderly population and the elderly are more prone to developing delirium after surgery. Dexmedetomidine is currently approved for use for 24 hours in patients on ventilators in the ICU. Study participation will last from within 72 hours of surgery to 3 days after surgery, continue throughout surgery and up to 2 hours after surgery. Delirium will be assessed prior to surgery and for 72 hours after surgery. This assessment will consist of questions to determine memory and thought process. At discharge patient's resource utilization will be evaluated and thirty days after surgery questions will be asked regarding quality of life.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
52
Percentage of subjects who experienced any postoperative delirium up to 3 days after the end of study drug infusion
The presence of postoperative delirium will be determined by Confusion Assessment Method for the Intensive Care Unit (CAM-ICU).
Time frame: Twice daily (between 6:00-9:00 AM and 5:00-8:00 PM) until 3 days after the end of study drug infusion.
Duration of postoperative delirium as determined by CAM-ICU up to 3 days after end of study drug infusion
Time frame: Twice daily (between 6:00-9:00 AM and 5:00-8:00 PM) until 3 days after the end of study drug infusion.
Percentage of subjects who experienced postoperative delirium each day after end of study drug infusion
Time frame: Twice daily (between 6:00-9:00 AM and 5:00-8:00 PM) until 3 days after the end of study drug infusion.
Perioperative use of all analgesics (Fentanyl, Morphine, and oral analgesics)
Time frame: During the intraoperative period, Post-anesthesia care unit period and the 3 days Follow-up Period.
Postoperative use of Midazolam
If RASS \>0, midazolam (MDZ) 0.5-1 mg IV will be given until RASS \<0. While in PACU during study drug infusion period, MDZ (0.5-1 mg IV) will be given if RASS \>+1 under allowed maximum dose of study drug. RASS range: * +4 Combative -Overtly combative, violent, immediate danger to staff * +3 Very agitated- Pulls or removes tubes or catheters, aggressive * +2 Agitated- Frequent non-purposeful movements, fights ventilator * +1 Restless- Anxious, but movements not aggressive or vigorous * 0 Alert and calm * -1 Drowsy - Not fully alert, but sustained awakening (eye opening, eye contact) to voice (\>10 sec) * -2 Light sedation - Briefly awakens with eye contact to voice (\<10 sec) * -3 Moderate sedation - Movement or eye opening to voice (but no eye contact) * -4 Deep sedation No response to voice, but movement or eye opening to physical stimulation * -5 Unarousable No response to voice or physical stimulation
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Loma Linda University Medical Center
Loma Linda, California, United States
LAC-USC Medical Center Los Angeles
Los Angeles, California, United States
Huntington Memorial Hospital
Pasadena, California, United States
University of Miami-Jackson Memorial Medical Center
Miami, Florida, United States
Southeastern Clinical Research Consultants
Orlando, Florida, United States
Orlando Regional Healthcare, Critical Care Medicine
Orlando, Florida, United States
G and G Research, Inc.
Vero Beach, Florida, United States
Orthopaedic Center of Vero Beach
Vero Beach, Florida, United States
Medical College of Georgia
Augusta, Georgia, United States
University of Iowa Hospitals and Clinics, Dept. of Anesthesia
Iowa City, Iowa, United States
...and 20 more locations
Time frame: During the PACU period (Approximately 2 hours)
Time-to-Aldrete score of ≥9
A score of 9-10 indicates the subject has recovered from anesthesia and is ready for discharge from the PACU.
Time frame: Every 15±5 minutes from arrival in the PACU (Approximately 2 hours)
Length of post-operative hospital stay
Time frame: From the post operative period until subject discharged from hospital