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Conscious SedationPhase 4NCT00318955

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

A Phase 4 study testing Dexmedetomidine and Propofol in people with Conscious Sedation, run by Hospira, now a wholly owned subsidiary of Pfizer at 13 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Conscious Sedation
What is being tested?
Dexmedetomidine and Propofol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
13 sitesJapan
Study dates
Nov 2005to Aug 2006
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 16Show fewer
  • 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.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Japan13 sites

  • Nippon Medical School Hospital

    Bunkyo-ku, Tokyo

  • Hamamatsu University Hospital

    Hamamatsu, Shizuoka

  • Kyushu University Hospital

    Higashiku, Fukuoka

  • Hirosaki University Hospital

    Hirosaki-shi, Aomori

  • Kagoshima University Medical and Dental Hospital

    Kagoshima, Kagoshima-ken

  • Osaka City General Hospital

    Miyakojima-ku, Osaka

  • Nagasaki University Hospital of Medicine and Dentistry

    Nagasaki, Nagasaki

  • Okayama University Hospital of Medicine and Dentistry

    Okayama, Okayama-ken

  • Kinki University Hospital

    Osaka-Sayama-Shi, Osaka

  • Kyoto University Hospital

    Sakyoku, Kyoto

  • Showa University Hospital

    Shinagawa-ku, Tokyo

  • Tokyo Women's Medical University Hospital

    Shinjuku-ku, Tokyo

  • Osaka University Hospital

    Suita, Osaka

Other trials in Japan

About this study

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

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.

Read the 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.

Keywords
Dexmedetomidine, Sedation, Extubation, Phase 4

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00318955
Study groupRoleWhat they receive
Dexmedetomidine groupExperimentalNot described
Receives: Drug: Dexmedetomidine
Propofol groupActive comparatorNot described
Receives: Drug: Propofol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of patients who maintained a Richmond Agitation-Sedation score =0, -1, -2

    Measured: Continuously from 1 hour before extubation or end of propofol infusion before extubation, whichever is later, to 1 hour after extubation

Secondary outcomes (11)

  1. Variations in vital signs (blood pressure and heart rate) in patients

    Measured: From 10 minutes before extubation to 10 minutes after extubation

  2. Percentage of patients who required analgesia and received supplemental fentanyl before and after extubation

    Measured: 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

  3. Percentage of patients with a total score of 3 on the Behavioral Pain Scale just before extubation

    Measured: 10±2 minutes before extubation, 2±1 minutes after extubation

  4. Percentage of patients who required supplemental sedation after extubation

    Measured: After extubation to 24 hours after the start of study drug infusion.

  5. Percentage of patients who require post-extubation analgesia and who received supplemental fentanyl after extubation

    Measured: After extubation to 24 hours after the start of study drug infusion.

  6. Amount of supplemental fentanyl required after extubation

    Measured: After extubation to 24 hours after the start of study drug infusion.

  7. Ratio of time with a Richmond Agitation-Sedation score ≥+1

    Measured: From 1 hour before extubation or the end of propofol infusion before extubation, whichever was later, to 1 hour after extubation

  8. Distribution of Richmond Agitation-Sedation score most frequently recorded while intubated

    Measured: From the start of study drug administration to 1 hour before the expected time of extubation.

  9. Ease of patient management on the basis of a questionnaire to physicians and nurses

    Measured: 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).

  10. Assessment of interactions between dexmedetomidine and propofol or fentanyl

    Measured: After propofol or fentanyl administration (Pre-dose and Post dose [5 and 10 minutes])

  11. Patient self-evaluation of experiences during their stay in the ICU

    Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2006 (estimated)
  2. Study startNov 2005
  3. Primary completionAug 2006
  4. Study completionAug 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00318955
Sponsor's protocol ID
DEX-401
Status last verified
Jun 2015
First submitted
18 Apr 2006
Last updated
20 Mar 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 2669909

  • 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,

  • 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.

    PubMed 6133664

  • 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

  • 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.

    PubMed 4098972

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dexmedetomidine and Propofol in people with Conscious Sedation, run by Hospira, now a wholly owned subsidiary of Pfizer at 13 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00318955, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2017.

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