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

NCT00318955 | Completed Phase 4

• 1 other identifier: DEX-401
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 13

Brief 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.

Conditions

Conscious Sedation

Keywords

Dexmedetomidine, Sedation, Extubation, Phase 4

Outcome Measures

Primary Outcomes (1)

• Percentage of patients who maintained 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 Outcomes (11)

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

  From 10 minutes before extubation to 10 minutes after extubation

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

  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

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

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

• Percentage of patients who required supplemental sedation after extubation

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

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

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

Study Arms (2)

Dexmedetomidine group

EXPERIMENTAL

Drug: Dexmedetomidine

Propofol group

ACTIVE COMPARATOR

Drug: Propofol

Interventions

Dexmedetomidine DRUG

Dexmedetomidine group

Propofol DRUG

Propofol group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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%.

Sponsors & Collaborators

• Hospira, now a wholly owned subsidiary of Pfizer: lead
• Maruishi Pharmaceutical: collaborator

Study Sites (13)

Hirosaki University Hospital

Hirosaki-shi, Aomori, Japan

Location

Kyushu University Hospital

Higashiku, Fukuoka, Japan

Location

Kagoshima University Medical and Dental Hospital

Kagoshima, Kagoshima-ken, Japan

Location

Kyoto University Hospital

Sakyoku, Kyoto, Japan

Location

Nagasaki University Hospital of Medicine and Dentistry

Nagasaki, Nagasaki, Japan

Location

Okayama University Hospital of Medicine and Dentistry

Okayama, Okayama-ken, Japan

Location

Osaka City General Hospital

Miyakojima-ku, Osaka, Japan

Location

Kinki University Hospital

Osaka-Sayama-Shi, Osaka, Japan

Location

Osaka University Hospital

Suita, Osaka, Japan

Location

Hamamatsu University Hospital

Hamamatsu, Shizuoka, Japan

Location

Nippon Medical School Hospital

Bunkyo-ku, Tokyo, Japan

Location

Showa University Hospital

Shinagawa-ku, Tokyo, Japan

Location

Tokyo Women's Medical University Hospital

Shinjuku-ku, Tokyo, Japan

Location

Related Publications (12)

• 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.

  PMID: 2669909 BACKGROUND

• Minoru Kaneshiro. Analgesic and Sedatin during mechanical ventilation, ICU and CCU 14:14643-648,1990

  BACKGROUND

• Syu Matsukawa, et.al.Sedation during ventilation control, ICU and CCU 14:603-608,1990

  BACKGROUND

• Megumu Tagami et.al. Post-operative analgesic and sedation control,

  BACKGROUND

• 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.

  PMID: 6133664 BACKGROUND

• Hidekazu Yukioka, et.al. Current status of analgesic and sedation control in ICU. Japan ICU Treatment Association's Magazine 1:13-19, 1994

  BACKGROUND

• Masayoshi Hyodo et.al. Anesthetic Science, 10th edition, Kinpodo, ppl 213-219

  BACKGROUND

• Ikuto Yoshiya. Section 4; Pharmacology for Anesthesia, Introduction to Anesthesiology, 7th edition, Nagai Shoten,pp439-447, 1993

  BACKGROUND

• Ikuto Yoshiya: Sedation and Analgesia for Intensive Care Patients. Anesthesia 21(2):2-6, 333-337, 2000

  BACKGROUND

• Costas Katsanoulas. Concluding Remarks: Redefining Intensive Care Unit Sedation, International Congress and Symposium Series 221, 83-88

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 4098972 BACKGROUND

MeSH Terms

Interventions

Dexmedetomidine; Propofol

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Misa Kawai

  Hospira, now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2006
• First Posted: April 27, 2006
• Study Start: November 1, 2005
• Primary Completion: August 1, 2006
• Study Completion: August 1, 2006
• Last Updated: March 20, 2017

Record last verified: 2015-06

Locations

JP (13)