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Trial record 78 of 326 for:    clonidine

Use of Clonidine to Prevent Withdrawal Following Prolonged Dexmedetomidine Infusions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02404077
Recruitment Status : Completed
First Posted : March 31, 2015
Last Update Posted : April 20, 2017
Information provided by (Responsible Party):
Joseph D. Tobias, Nationwide Children's Hospital

Brief Summary:
The investigators' clinical practice makes use of oral clonidine as a means of transitioning from intravenous dexmedetomidine following prolonged infusions (more than 3-5 days). Although this is common clinical practice, there is limited clinical data to demonstrate the efficacy of this technique and to provide clonidine dosing guidelines. The purpose of this study is to retrospectively review the investigators' experience with the use of oral clonidine to prevent withdrawal following the prolonged administration of dexmedetomidine.

Condition or disease Intervention/treatment
Sedation Drug: Clonidine

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Study Type : Observational
Actual Enrollment : 712 participants
Observational Model: Cohort
Time Perspective: Retrospective
Study Start Date : April 2015
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Patients who received clonidine following prolonged dexmedetomidine infusions
Drug: Clonidine

Primary Outcome Measures :
  1. Evidence of withdrawal [ Time Frame: Twice a day from the first day of taper of dexmedetomidine until 72 hrs. after the last dose ]
    Withdrawal is assessed using the Withdrawal Assessment Tool-1 (WAT-1). The 19-item assessment consists of (1) a review of the patient's record for the past 12 hours, (2) direct observation of the patient for 2 minutes, (3) patient assessment during a progressive stimulated exam routinely performed to assess level of consciousness at the beginning of each 12-hour shift, and finally (4) assessment of post-stimulus recovery.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ICU patients who have been on prolonged dexmedetomidine infusions.

Inclusion Criteria:

  • Patients who received clonidine during the transition from dexmedetomidine.

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02404077

Sponsors and Collaborators
Joseph D. Tobias
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Principal Investigator: Joseph D Tobias, MD Nationwide Children's Hospital

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Responsible Party: Joseph D. Tobias, Chairman, Dept. of Anesthesiology & Pain Medicine, Nationwide Children's Hospital Identifier: NCT02404077     History of Changes
Other Study ID Numbers: IRB15-00256
First Posted: March 31, 2015    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: April 2017
Keywords provided by Joseph D. Tobias, Nationwide Children's Hospital:
Additional relevant MeSH terms:
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Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Autonomic Agents