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Post-Marketing Clinical Study to Assess Efficacy and Safety of Dexmedetomidine in Post-Operative Patients

This study has been completed.

Sponsors and Collaborators: Hospira, Inc.
Maruishi Pharmaceutical
Information provided by: Hospira, Inc.
ClinicalTrials.gov Identifier: NCT00318955
  Purpose

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   

U.S. FDA Resources

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

Further study details as provided by Hospira, Inc.:

Primary Outcome Measures:
  • Percent of patients who maintain 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

Secondary Outcome Measures:
  • The variations in vital signs (blood pressure and heart rate) in patients from 10 minutes before extubation to 10 minutes after extubation

Estimated Enrollment:   80
Study Start Date:   November 2005
Study Completion Date:   August 2006

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Patient or legally acceptable representative (if acceptable by Institutional Review Board/Ethics Committee) has signed and dated the Informed Consent after the study has been fully explained
  • Patient is male or female; at least 20 years of age
  • Patient who is in condition of American Society of Anesthesiology (ASA) I to III Class preoperatively
  • Patient is orally intubated and anticipated to require sedation for mechanical ventilation for a minimum period of 4 hours following open-heart surgery, coronary artery bypass grafting (CABG), or major vascular surgery
  • If patient is female with child bearing potential, she is to be non-pregnant, and not lactating

Exclusion Criteria:

  • Patient has serious central nervous system (CNS) trauma
  • Patient has undergone or requires intracranial surgery during current hospitalization
  • Patient requires the use of neuromuscular blocking agents after admission to ICU, except for the insertion of the endotracheal tube
  • Patient requires epidural or spinal analgesia/anesthesia after the end of surgery and during his/her ICU stay
  • Patient in whom propofol or opioids are contraindicated
  • Patient has known or suspected allergy to any medication that might be administered during the course of the study
  • Patient is grossly obese (i.e., body mass index > 35)
  • Patient is currently hospitalized for drug overdose
  • Patient in whom alpha-2 antagonists or alpha-2 agonists are contraindicated
  • Patient is currently being treated or has been treated within the last 30 days with alpha-2 agonist or antagonist
  • Patient has participated in a trial with any experimental drug within 30 days prior to admission to the ICU
  • Terminally ill patient, whose life duration expectancy is no more or around 24 hours
  • Patient is considered unable to undergo any procedure required by the protocol
  • Patient with excessive bleeding which will likely require resurgery
  • Patient has an ejection fraction of < 30%
  • In the Investigator's opinion, patient has any symptom or factor, which might increase risk to the patient or preclude obtaining satisfactory study data
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00318955

Locations
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

Sponsors and Collaborators
Hospira, Inc.
Maruishi Pharmaceutical

Investigators
Study Director:     Misa Kawai     Hospira, Inc.    
  More Information


Publications:
Hidekazu Yukioka, et.al. Current status of analgesic and sedation control in ICU. Japan ICU Treatment Association's Magazine 1:13-19, 1994
 
Masayoshi Hyodo et.al. Anesthetic Science, 10th edition, Kinpodo, ppl 213-219
 
Ikuto Yoshiya. Section 4; Pharmacology for Anesthesia, Introduction to Anesthesiology, 7th edition, Nagai Shoten,pp439-447, 1993
 
Costas Katsanoulas. Concluding Remarks: Redefining Intensive Care Unit Sedation, International Congress and Symposium Series 221, 83-88
 
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
 
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.
 

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

Keywords provided by Hospira, Inc.:
Dexmedetomidine, Sedation, Extubation, Phase 4  

Study placed in the following topic categories:
Dexmedetomidine

Additional relevant MeSH terms:
Neurotransmitter Agents
Adrenergic alpha-Agonists
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Pharmacologic Actions
Adrenergic Agonists
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Hypnotics and Sedatives
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 06, 2008




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