Long-term Clinical Study Evaluating the Safety and Efficacy of Dexmedetomidine in ICU Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-06-30

Brief Summary

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Evaluate efficacy and safety of dexmedetomidine long term administration in ICU patients who require more than 24 hours sedation.

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Detailed Description

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According to the current dexmedetomidine indication, the duration of dexmedetomidine administration is limited within 24 hours. However, there is a strong demand from the medical specialists for continued administration of dexmedetomidine in excess of 24 hours in the medical practice because a large number of patients require sedation for more than 24 hours in ICU. To meet such clinical demand, it was planned to conduct a phase III long-term administration study of dexmedetomidine to obtain the approval on the infusion of dexmedetomidine for more than 24 hours.

Conditions

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Sedation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dexmedetomidine

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

Interventions

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Dexmedetomidine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patient or legally acceptable representative (if acceptable by Institutional Review Board/Ethics Committee) has signed and dated the Informed Consent after the study had been fully explained.
2. Patient is male or female, at least 20 years of age.
3. In case of surgical ICU patient, who is in condition of American Society of Anesthesiologists (ASA) I to III Class preoperatively.
4. Patient is on mechanical ventilation and anticipated to require sedation more than 24 hours following a surgery.
5. If patient is female with child bearing potential, she is to be non-pregnant, and not lactating.

Exclusion Criteria

1. Patient has serious central nervous system (CNS) trauma.
2. Patient requires the use of neuromuscular blocking agents after admission to ICU, except for the insertion of the endotracheal tube.
3. Patient is hospitalized for drug overdose within the last 30 days.
4. Patient in whom alpha-2 antagonists or alpha-2 agonists are contraindicated.
5. Patient is currently being treated or has been treated within the last 30 days with alpha-2 agonist or antagonist.
6. Patient has participated in a trial with any experimental drug within 30 days prior to admission to the ICU.
7. Terminally ill patient, whose life duration expectancy is no more or around 30 days.
8. Patient is considered unable to undergo any procedure required by the protocol.
9. Patient with excessive bleeding which will likely require surgery.
10. In the Investigator's opinion, patient has any symptom or factor, which might increase risk to the patient or preclude obtaining satisfactory study data.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No