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 (Responsible Party):
Hospira, Inc.
ClinicalTrials.gov Identifier:
NCT00318955
First received: April 18, 2006
Last updated: June 29, 2015
Last verified: June 2015
  Purpose

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.


Condition Intervention Phase
Conscious Sedation
Drug: Dexmedetomidine
Drug: Propofol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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:
  • Percentage of patients who maintained a Richmond Agitation-Sedation score =0, -1, -2 [ Time Frame: Continuously from 1 hour before extubation or end of propofol infusion before extubation, whichever is later, to 1 hour after extubation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Variations in vital signs (blood pressure and heart rate) in patients [ Time Frame: From 10 minutes before extubation to 10 minutes after extubation ] [ Designated as safety issue: No ]
  • Percentage of patients who required analgesia and received supplemental fentanyl before and after extubation [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Percentage of patients with a total score of 3 on the Behavioral Pain Scale just before extubation [ Time Frame: 10±2 minutes before extubation, 2±1 minutes after extubation ] [ Designated as safety issue: No ]
  • Percentage of patients who required supplemental sedation after extubation [ Time Frame: After extubation to 24 hours after the start of study drug infusion. ] [ Designated as safety issue: No ]
  • Percentage of patients who require post-extubation analgesia and who received supplemental fentanyl after extubation [ Time Frame: After extubation to 24 hours after the start of study drug infusion. ] [ Designated as safety issue: No ]
  • Amount of supplemental fentanyl required after extubation [ Time Frame: After extubation to 24 hours after the start of study drug infusion. ] [ Designated as safety issue: No ]
  • Ratio of time with a Richmond Agitation-Sedation score ≥+1 [ Time Frame: From 1 hour before extubation or the end of propofol infusion before extubation, whichever was later, to 1 hour after extubation ] [ Designated as safety issue: No ]
  • Distribution of Richmond Agitation-Sedation score most frequently recorded while intubated [ Time Frame: From the start of study drug administration to 1 hour before the expected time of extubation. ] [ Designated as safety issue: No ]
  • Ease of patient management on the basis of a questionnaire to physicians and nurses [ Time Frame: 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). ] [ Designated as safety issue: No ]
  • Assessment of interactions between dexmedetomidine and propofol or fentanyl [ Time Frame: After propofol or fentanyl administration (Pre-dose and Post dose [5 and 10 minutes]) ] [ Designated as safety issue: No ]
  • Patient self-evaluation of experiences during their stay in the ICU [ Time Frame: 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). ] [ Designated as safety issue: No ]

Enrollment: 85
Study Start Date: November 2005
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dexmedetomidine group Drug: Dexmedetomidine
Active Comparator: Propofol group Drug: Propofol

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 with serious disturbance of the central nervous system (disturbance of consciousness).
  • Patient has undergone or requires intracranial surgery during current hospitalization
  • Patient requires muscle relaxant drugs after admission to the ICU (except when an endotracheal tube is reinserted).
  • Patient requires epidural or intrathecal administration of analgesia/anesthesia after surgery and during their ICU stay.
  • Patients for whom propofol or opioids are contraindicated.
  • Patient has known or suspected allergies to any medication that might be administered during the course of the study.
  • Patient is obese (body mass index >35)
  • Patient was recently hospitalized for drug overdose
  • Patient for whom alpha-2 antagonists or alpha-2 agonists are contraindicated
  • Patient is currently or previously treated, within 30 days before the start of the study, with an alpha-2 antagonist or alpha-2 receptor agonist.
  • Patient has participated in another clinical study within 30 days prior to admission to the ICU and patient is currently participating in another clinical study.
  • Patient was diagnosed with severe symptoms and judged likely to die within 24 hours.
  • Patient is considered unable to undergo all procedures required by the protocol.
  • Patient with excessive bleeding that is likely require reoperation.
  • Patient with an ejection fraction of < 30%.
  • Patient, in the opinion of the investigator or subinvestigator in the post-marketing clinical study, that has symptoms or factors that may increase his/her risk as a result of the clinical study, or that may not provide sufficient 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 Hospital
Hirosaki-shi, Aomori, Japan
Kyushu University Hospital
Higashi-ku, Fukuoka, Japan
Kyoto University Hospital
Sakyoku, Kyoto, 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-City, 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
Kagoshima University Medical and Dental Hospital
Kagoshima, Japan
Nagasaki University Hospital of Medicine and Dentistry
Nagasaki, Japan
Okayama University Hospital of Medicine and Dentistry
Okayama, Japan
Sponsors and Collaborators
Hospira, Inc.
Maruishi Pharmaceutical
Investigators
Study Director: Misa Kawai Hospira, Inc.
  More Information

Publications:
Minoru Kaneshiro. Analgesic and Sedatin during mechanical ventilation, ICU and CCU 14:14643-648,1990
Syu Matsukawa, et.al.Sedation during ventilation control, ICU and CCU 14:603-608,1990
Megumu Tagami et.al. Post-operative analgesic and sedation control,
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

Responsible Party: Hospira, Inc.
ClinicalTrials.gov Identifier: NCT00318955     History of Changes
Obsolete Identifiers: NCT00248001
Other Study ID Numbers: DEX-401
Study First Received: April 18, 2006
Last Updated: June 29, 2015
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 August 27, 2015