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Sponsors and Collaborators: |
Hospira, Inc. Maruishi Pharmaceutical |
Information provided by: | Hospira, Inc. |
ClinicalTrials.gov Identifier: | NCT00318955 |
To assess efficacy and safety of dexmedetomidine at the time of extubation and after extubation, in patients requiring postoperative sedation in the ICU.
Condition | Intervention | Phase |
Conscious Sedation |
Drug: Dexmedetomidine |
Phase IV |
ChemIDplus related topics: | Dexmedetomidine Dexmedetomidine hydrochloride |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment |
Official Title: | A Post-Marketing, Open-Label, Randomized, Comparative Study Comparing the Usefulness of Dexmedetomidine at the Time of Extubation and Post Extubation Period to Other Sedative Management in Post-Operative Patients |
Estimated Enrollment: | 80 |
Study Start Date: | November 2005 |
Study Completion Date: | August 2006 |
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.
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Japan, Aomori | |||||
Hirosaki University School of Medicine and Hospital | |||||
Hirosaki, Aomori, Japan, 036-8563 | |||||
Japan, Fukuoka | |||||
Kyoshu University Hospital | |||||
Fukuoka-City, Fukuoka, Japan, 812-8582 | |||||
Japan, Kagoshima | |||||
Kagoshima University Hospital | |||||
Kagoshima-City, Kagoshima, Japan, 890-8520 | |||||
Japan, Kyoto | |||||
Kyoto University Hospital | |||||
Kyoto-City, Kyoto, Japan, 606-8507 | |||||
Japan, Nagasaki | |||||
Nagasaki University Hospital of Medicine and Dentistry | |||||
Nagasaki-City, Nagasaki, Japan, 852-8501 | |||||
Japan, Okayama | |||||
Okayama University Hospital | |||||
Okayama-City, Okayama, Japan, 700-8558 | |||||
Japan, Osaka | |||||
Kinki University Hospital | |||||
Osakasayama-City, Osaka, Japan, 589-8511 | |||||
Osaka University Hospital | |||||
Suita-City, Osaka, Japan, 565-0871 | |||||
Osaka City General Hospital | |||||
Osaka-City, Osaka, Japan, 534-0021 | |||||
Japan, Sizuoka | |||||
Hamamatsu Medical University Hospital | |||||
Hamamatsu-City, Sizuoka, Japan, 431-3192 | |||||
Japan, Tokyo | |||||
Nippon Medical School Hospital | |||||
Bunkyo-ku, Tokyo, Japan, 113-8603 | |||||
Showa University Hospital | |||||
Shinagawa-ku, Tokyo, Japan, 142-8666 | |||||
Tokyo Women's Medical University Hospital | |||||
Shinjuku-ku, Tokyo, Japan, 162-8666 |
Hospira, Inc. |
Maruishi Pharmaceutical |
Study Director: | Misa Kawai | Hospira, Inc. |
Hidekazu Yukioka, et.al. Current status of analgesic and sedation control in ICU. Japan ICU Treatment Association's Magazine 1:13-19, 1994
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Masayoshi Hyodo et.al. Anesthetic Science, 10th edition, Kinpodo, ppl 213-219
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Ikuto Yoshiya. Section 4; Pharmacology for Anesthesia, Introduction to Anesthesiology, 7th edition, Nagai Shoten,pp439-447, 1993
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Costas Katsanoulas. Concluding Remarks: Redefining Intensive Care Unit Sedation, International Congress and Symposium Series 221, 83-88
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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
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Hewitt PB. Subjective follow-up of patients from a surgical intensive therapy ward. Br Med J. 1970 Dec 12;4(736):669-73. No abstract available.
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Study ID Numbers: | DEX-401 |
First Received: | April 18, 2006 |
Last Updated: | September 5, 2007 |
ClinicalTrials.gov Identifier: | NCT00318955 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
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