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| Name | Class |
|---|---|
| Maruishi Pharmaceutical | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine group | Experimental |
| |
| Propofol group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug |
| ||
| Propofol |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients who maintained a Richmond Agitation-Sedation score =0, -1, -2 | Continuously from 1 hour before extubation or end of propofol infusion before extubation, whichever is later, to 1 hour after extubation |
| Measure | Description | Time Frame |
|---|---|---|
| Variations in vital signs (blood pressure and heart rate) in patients | From 10 minutes before extubation to 10 minutes after extubation | |
| Percentage of patients who required analgesia and received supplemental fentanyl before and after extubation | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Misa Kawai | Hospira, now a wholly owned subsidiary of Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hirosaki University Hospital | Hirosaki-shi | Aomori | Japan | |||
| Kyushu University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2669909 | Background | Aitkenhead AR. Analgesia and sedation in intensive care. Br J Anaesth. 1989 Aug;63(2):196-206. doi: 10.1093/bja/63.2.196. No abstract available. | |
| Background | Minoru Kaneshiro. Analgesic and Sedatin during mechanical ventilation, ICU and CCU 14:14643-648,1990 | ||
| Background | Syu Matsukawa, et.al.Sedation during ventilation control, ICU and CCU 14:603-608,1990 | ||
| Background | Megumu Tagami et.al. Post-operative analgesic and sedation control, | ||
| 6133664 |
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|
| Percentage of patients with a total score of 3 on the Behavioral Pain Scale just before extubation | 10±2 minutes before extubation, 2±1 minutes after extubation |
| Percentage of patients who required supplemental sedation after extubation | 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 | After extubation to 24 hours after the start of study drug infusion. |
| Amount of supplemental fentanyl required after extubation | After extubation to 24 hours after the start of study drug infusion. |
| Ratio of time with a Richmond Agitation-Sedation score ≥+1 | From 1 hour before extubation or the end of propofol infusion before extubation, whichever was later, to 1 hour after extubation |
| Distribution of Richmond Agitation-Sedation score most frequently recorded while intubated | 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 | 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 | 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 | 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). |
| Higashiku |
| Fukuoka |
| Japan |
| Kagoshima University Medical and Dental Hospital | Kagoshima | Kagoshima-ken | Japan |
| 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 |
| Nippon Medical School Hospital | Bunkyo-ku | Tokyo | Japan |
| Showa University Hospital | Shinagawa-ku | Tokyo | Japan |
| Tokyo Women's Medical University Hospital | Shinjuku-ku | Tokyo | Japan |
| Background |
| Greenblatt DJ, Divoll M, Abernethy DR, Ochs HR, Shader RI. Clinical pharmacokinetics of the newer benzodiazepines. Clin Pharmacokinet. 1983 May-Jun;8(3):233-52. doi: 10.2165/00003088-198308030-00003. |
| Background | Hidekazu Yukioka, et.al. Current status of analgesic and sedation control in ICU. Japan ICU Treatment Association's Magazine 1:13-19, 1994 |
| Background | Masayoshi Hyodo et.al. Anesthetic Science, 10th edition, Kinpodo, ppl 213-219 |
| Background | Ikuto Yoshiya. Section 4; Pharmacology for Anesthesia, Introduction to Anesthesiology, 7th edition, Nagai Shoten,pp439-447, 1993 |
| Background | Ikuto Yoshiya: Sedation and Analgesia for Intensive Care Patients. Anesthesia 21(2):2-6, 333-337, 2000 |
| Background | Costas Katsanoulas. Concluding Remarks: Redefining Intensive Care Unit Sedation, International Congress and Symposium Series 221, 83-88 |
| Background | Mantz,J., Singer,M. Importance of Patient Orientation and Rousability as Components of Intensive Care Unit Sedation, International Congress and Symposium Series 221, 23-29 |
| 4098972 | Background | Hewitt PB. Subjective follow-up of patients from a surgical intensive therapy ward. Br Med J. 1970 Dec 12;4(5736):669-73. doi: 10.1136/bmj.4.5736.669. |
| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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