Use of Clonidine to Prevent Withdrawal Following Prolonged Dexmedetomidine Infusions

Completed

• Conditions: Sedation
• Interventions: Drug: Clonidine

• Registration Number: NCT02404077
• Lead Sponsor: Joseph D. Tobias

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-24
• Study First Submitted QC: 2015-03-30
• Study First Posted: 2015-03-31
• Study Start: 2015-04
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-19
• Last Update Posted: 2017-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 712

Inclusion Criteria

• Patients who received clonidine during the transition from dexmedetomidine.

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Clonidine	Clonidine	Patients who received clonidine following prolonged dexmedetomidine infusions

Primary Outcome Measures

Name	Time	Method
Evidence of withdrawal	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.