The purpose of this study is to assess efficacy and safety of dexmedetomidine at the time of extubation and after extubation, in patients requiring postoperative sedation in the ICU.
The study is to conduct as a phase IV post-marketing clinical study in accordance with the approval condition of dexmedetomidine hydrochloride in Japan. The study will compare the use of dexmedetomidine in patient management at the time of extubation with other sedative/ analgesic management, Comparison is made in the use of dexmedetomidine in patient management between a group in which management is performed with dexmedetomidine and a group in which standard management is performed with propofol in patients requiring postoperative sedation in the ICU The usefulness of dexmedetomidine during postextubation period is also evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
85
Hirosaki University Hospital
Hirosaki-shi, Aomori, Japan
Kyushu University Hospital
Higashiku, Fukuoka, Japan
Kagoshima University Medical and Dental Hospital
Kagoshima, Kagoshima-ken, Japan
Percentage of patients who maintained a Richmond Agitation-Sedation score =0, -1, -2
Time frame: Continuously from 1 hour before extubation or end of propofol infusion before extubation, whichever is later, to 1 hour after extubation
Variations in vital signs (blood pressure and heart rate) in patients
Time frame: From 10 minutes before extubation to 10 minutes after extubation
Percentage of patients who required analgesia and received supplemental fentanyl before and after extubation
Time frame: From 7 days prior to surgery to the start of surgery, and from the end of surgery to 48 hrs after the start of infusion
Percentage of patients with a total score of 3 on the Behavioral Pain Scale just before extubation
Time frame: 10±2 minutes before extubation, 2±1 minutes after extubation
Percentage of patients who required supplemental sedation after extubation
Time frame: After extubation to 24 hours after the start of study drug infusion.
Percentage of patients who require post-extubation analgesia and who received supplemental fentanyl after extubation
Time frame: After extubation to 24 hours after the start of study drug infusion.
Amount of supplemental fentanyl required after extubation
Time frame: After extubation to 24 hours after the start of study drug infusion.
Ratio of time with a Richmond Agitation-Sedation score ≥+1
Time frame: From 1 hour before extubation or the end of propofol infusion before extubation, whichever was later, to 1 hour after extubation
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Kyoto University Hospital
Sakyoku, Kyoto, Japan
Nagasaki University Hospital of Medicine and Dentistry
Nagasaki, Nagasaki, Japan
Okayama University Hospital of Medicine and Dentistry
Okayama, Okayama-ken, Japan
Osaka City General Hospital
Miyakojima-ku, Osaka, Japan
Kinki University Hospital
Osaka-Sayama-Shi, Osaka, Japan
Osaka University Hospital
Suita, Osaka, Japan
Hamamatsu University Hospital
Hamamatsu, Shizuoka, Japan
...and 3 more locations
Distribution of Richmond Agitation-Sedation score most frequently recorded while intubated
Time frame: From the start of study drug administration to 1 hour before the expected time of extubation.
Ease of patient management on the basis of a questionnaire to physicians and nurses
Time frame: Conducted to the greatest possible extent, at ICU discharge or at 36 hours after the start of drug administration, whichever is earlier (in Part II only).
Assessment of interactions between dexmedetomidine and propofol or fentanyl
Time frame: After propofol or fentanyl administration (Pre-dose and Post dose [5 and 10 minutes])
Patient self-evaluation of experiences during their stay in the ICU
Time frame: Conducted to the greatest possible extent, at ICU discharge or at 36 hours after the start of drug administration, whichever is earlier (in Part II only).