A Research Study to Evaluate the Effectiveness of Dexmedetomidine in Preventing Delirium After Hip Fracture Repair Surgery
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||A Phase III,Randomized, Double-Blind, Placebo-Controlled, Two-Arm Parallel, Multicenter Study Evaluating the Efficacy and Safety of Dexmedetomidine in the Prevention of Postoperative Delirium in Subjects Undergoing Surgery for Fractured Hip With General Anesthesia|
- Percentage of subjects who experienced any postoperative delirium up to 3 days after the 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. ] [ Designated as safety issue: No ]The presence of postoperative delirium will be determined by Confusion Assessment Method for the Intensive Care Unit (CAM-ICU).
- 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. ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: No ]
- Postoperative use of Midazolam [ Time Frame: During the PACU period (Approximately 2 hours) ] [ Designated as safety issue: No ]
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.
- +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
- Time-to-Aldrete score of ≥9 [ Time Frame: Every 15±5 minutes from arrival in the PACU (Approximately 2 hours) ] [ Designated as safety issue: No ]A score of 9-10 indicates the subject has recovered from anesthesia and is ready for discharge from the PACU.
- Length of post-operative hospital stay [ Time Frame: From the post operative period until subject discharged from hospital ] [ Designated as safety issue: No ]
|Study Start Date:||April 2007|
|Study Completion Date:||November 2007|
|Primary Completion Date:||November 2007 (Final data collection date for primary outcome measure)|
|Experimental: Dexmedetomidine||Drug: Dexmedetomidine|
|Placebo Comparator: Placebo (PBO)||Drug: Placebo|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00460473
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