The purpose of this study is to evaluate the efficacy and the safety of DA-9501 (Dexmedetomidine) in sedation during the surgery or medical procedure without intubation under monitored sedation care.
Phase III, randomized, placebo controlled, double blind, parallel comparative study (Therapeutic confirmatory trial), to evaluate the efficacy and the safety of Dexmedetomidine in non-intubated patients who require sedation during surgery or medical procedure under monitored sedation care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
162
Asahikawa Medical University Hospital
Asahikawa, Hokkaido, Japan
Hyogo Prefectural Amagasaki Hospital
Amagasaki, Hyōgo, Japan
Incidence of patients who did not require rescue administration of propofol to achieve and maintain Observer's Assessment of Alertness/Sedation (OAA/S) Score ≤4 during the study drug administration
Time frame: Pre-dose, every 5 ± 2 minutes during study drug infusion and every 15 ± 2 minutes until 1 hour after study drug infusion. Before additional administration of sedative.
Administration frequency and dosage of propofol required to achieve and maintain OAA/S score ≤4 during the study drug administration
If the OAA/S score is 5, 0.2 mg/kg of propofol as a sedative is administered intravenously by slow "IV push" and the administration is to be repeated until the target level of sedation (OAA/S score ≤4) is achieved.
Time frame: After the start of study drug (20 ± 2 minutes), if the OAA/S score is 5.
Time to first rescue administration of propofol
Time frame: ≥15 minutes after the start of study drug infusion.
Incidence of patients who did not require rescue administration of fentanyl during the study drug administration
Time frame: After the surgery start, the administration of fentanyl is permissible as required to treat pain. In case of repeated dose, the dosing interval should be ≥15 minutes.
Administration frequency and dosage of fentanyl required during the study drug administration
Time frame: After the surgery start, the administration of fentanyl is permissible as required to treat pain. In case of repeated dose, the dosing interval should be ≥15 minutes.
Percentage of time spent OAA/S Score ≤4 during the study drug infusion
Time frame: Pre-dose, every 5 ± 2 minutes during study drug infusion and every 15 ± 2 minutes until 1 hour after study drug infusion. Before additional administration of sedative.
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Tsukuba University Hospital
Tsukuba, Ibaraki, Japan
Kagoshima University Medical and Dental Hospital
Kagoshima, Kagoshima-ken, Japan
Japanese Red Cross Kyoto Daini Hospital
Kyoto, Kyoto, Japan
University of Miyazaki Hospital
Miyazaki, Miyazaki, Japan
Okayama University Hospital
Okayama, Okayama-ken, Japan
Yuaikai Toyomijo Chuo Hospital
Toyomijo, Okinawa, Japan
Kansai Medical University Hirakata Hospital
Hirakata, Osaka, Japan
Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Osaka, Osaka, Japan
...and 8 more locations
Percentage of time spent OAA/S Score 3 to 4 during the study drug infusion
Time frame: Pre-dose, every 5 ± 2 minutes during study drug infusion and every 15 ± 2 minutes until 1 hour after study drug infusion. Before additional administration of sedative.
Time to attain an Aldrete score ≥9 following discontinuation of the study drug infusion
Time frame: Every 15 ± 2 minutes until the total score value becomes ≥9.
Visual Analogue Scale (VAS) score evaluation by Investigator or sub-investigator (ease of maintaining sedation level, hemodynamic stability, respiratory stability, subject's cooperativeness)
Time frame: Within 24 hours after completion of the study drug administration
Score evaluation of satisfaction and anxiety of the subject
Time frame: Within 24 hours after completion of the study drug administration (as much as possible)