Evaluate efficacy and safety of dexmedetomidine long term administration in ICU patients who require more than 24 hours sedation.
According to the current dexmedetomidine indication, the duration of dexmedetomidine administration is limited within 24 hours. However, there is a strong demand from the medical specialists for continued administration of dexmedetomidine in excess of 24 hours in the medical practice because a large number of patients require sedation for more than 24 hours in ICU. To meet such clinical demand, it was planned to conduct a phase III long-term administration study of dexmedetomidine to obtain the approval on the infusion of dexmedetomidine for more than 24 hours.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Hyogo Medical University Hospital
Nishinomiya, Hyōgo, Japan
Kagoshima University Hospital
Kagoshima, Kagoshima-ken, Japan
Kinki University Hospital
Sayama, Osaka, Japan
Osaka University Hospital
Incidence rate of adverse drug reactions of hypotension, hypertension and bradycardia which correspond to the protocol definitions
Definition: * Hypotension: dosing start or dose increase of vasopressor drug or use of fluid bolus ≥500 mL within 1 hour resulting from SBP\<60mmHg, DBP\<40mmHg or ≥50% lower than baseline. * Hypertension: dosing start or dose increase of intravenous anti-hypertensive medication resulting from SBP\>160, DBP\>100 or. ≥50% higher than baseline. * Bradycardia: dosing start or dose increase of positive chronotropic medication or use of pacemaker resulting from heart rate \<40bpm or ≥50% lower than baseline.
Time frame: Prior to study drug infusion, during the study drug infusion and 24 hours after study drug infusion end; maximum ≤28 days.
Percentage of with a Richmond Agitation-Sedation Sedation Score ≤0 during the study drug infusion
Time frame: Prior to study drug infusion, during the study drug infusion and 24 hours after study drug infusion end; maximum ≤28 days.
Percentage of time with a Richmond Agitation-Sedation Sedation Score =0, -1,-2 during the study drug infusion
Time frame: Prior to study drug infusion, during the study drug infusion and 24 hours after study drug infusion end; maximum ≤28 days.
Administration frequency and dosage of additional sedatives
Time frame: Prior to study drug infusion, during the study drug infusion and 24 hours after study drug infusion end; maximum ≤28 days.
Administration frequency and dosage of additional analgesics
Time frame: Prior to study drug infusion, during the study drug infusion and 24 hours after study drug infusion end; maximum ≤28 days.
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Suita, Osaka, Japan
Hamamatsu Medical University Hospital
Hamamatsu, Shizuoka, Japan
Nippon Medical School Hospital
Bunkyo-ku, Tokyo, Japan
Jikei University Hospital
Minato-ku, Tokyo, Japan
Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo, Japan
Keio University Hospital
Sinjuku-ku, Tokyo, Japan
Yamanashi University Hospital
Chūō, Yamanashi, Japan