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

NCT ID: NCT00318955

Last Updated: 2017-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2006-08-31

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.

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.

Conditions

Conscious Sedation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dexmedetomidine group

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

Propofol group

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

Interventions

Dexmedetomidine

Intervention Type: DRUG

Propofol

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maruishi Pharmaceutical

INDUSTRY

Sponsor Role: collaborator

Hospira, now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Misa Kawai

Role: STUDY_DIRECTOR

Hospira, now a wholly owned subsidiary of Pfizer

Locations

Hirosaki University Hospital

Hirosaki-shi, Aomori, Japan

Kyushu University Hospital

Higashiku, Fukuoka, Japan

Kagoshima University Medical and Dental Hospital

Kagoshima, Kagoshima-ken, Japan

Kyoto University Hospital

Sakyoku, Kyoto, Japan

Nagasaki University Hospital of Medicine and Dentistry

Nagasaki, Nagasaki, Japan

Okayama University Hospital of Medicine and Dentistry

Okayama, Okayama-ken, 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, 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

Countries

Japan

References

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.

Reference Type: BACKGROUND

PMID: 2669909 (View on PubMed)

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

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 6133664 (View on PubMed)

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

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

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

Reference Type: 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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 4098972 (View on PubMed)

Other Identifiers

DEX-401

Identifier Type: -

Identifier Source: org_study_id

NCT00248001

Identifier Type: -

Identifier Source: nct_alias