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

This study has been completed.
Sponsor:
Collaborator:
Maruishi Pharmaceutical
Information provided by:
Hospira, Inc.
ClinicalTrials.gov Identifier:
NCT00318955
First received: April 18, 2006
Last updated: September 5, 2007
Last verified: September 2007
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Japan
Hirosaki University School of Medicine and Hospital
Hirosaki, Aomori, Japan, 036-8563
Kyoshu University Hospital
Fukuoka-City, Fukuoka, Japan, 812-8582
Kagoshima University Hospital
Kagoshima-City, Kagoshima, Japan, 890-8520
Kyoto University Hospital
Kyoto-City, Kyoto, Japan, 606-8507
Nagasaki University Hospital of Medicine and Dentistry
Nagasaki-City, Nagasaki, Japan, 852-8501
Okayama University Hospital
Okayama-City, Okayama, Japan, 700-8558
Osaka City General Hospital
Osaka-City, Osaka, Japan, 534-0021
Kinki University Hospital
Osakasayama-City, Osaka, Japan, 589-8511
Osaka University Hospital
Suita-City, Osaka, Japan, 565-0871
Hamamatsu Medical University Hospital
Hamamatsu-City, Sizuoka, Japan, 431-3192
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
Ikuto Yoshiya: Sedation and Analgesia for Intensive Care Patients. Anesthesia 21(2):2-6, 333-337, 2000
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

ClinicalTrials.gov Identifier: NCT00318955     History of Changes
Obsolete Identifiers: NCT00248001
Other Study ID Numbers: DEX-401
Study First Received: April 18, 2006
Last Updated: September 5, 2007
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

Additional relevant MeSH terms:
Dexmedetomidine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Analgesics
Analgesics, Non-Narcotic
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014