At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 15 enrolled

Drug / intervention

Dexmedetomidinedrug

Likely dose

Dexmedetomidine 0.5 mcg/kgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01606852

NCT01606852Phase 2Completed

Compare CT.gov

Testing the Feasibility of Patient Controlled Sedation for Ventilated ICU Patients

University of Minnesota·interventional·Posted May 28, 2012·Updated Mar 13, 2018

In Brief

A Phase 2 clinical trial evaluating Dexmedetomidine for Acute Respiratory Failure and Anxiety. Completed, enrolled 15 participants across 1 site.

Detailed Summary

Mechanical ventilation (MV) is the most frequently used life-support modality in intensive care units (ICUs). To reduce anxiety, stress and promote tolerance of MV, nurses frequently administer a variety of sedative medications to their patients based on subjective observations. The investigators hypothesize that patient-controlled sedation, compared to clinician-directed sedation, will decrease sedative exposure while decreasing patient anxiety during the episode of mechanical ventilation.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsAcute Respiratory Failure, Anxiety

CountriesUnited States

CollaboratorsNational Institute of Nursing Research (NINR), Hospira, now a wholly owned subsidiary of Pfizer

Timeline

Phase 2CompletedFinished

20132014201520162017201820192020202120222023202420252026

First PostedMay 2012

Enrollment StartMar 2013

Primary CompletionJul 2014

Study CompletionJul 2015

TodayJul 2026

First PostedMay 28, 2012

Enrollment StartMar 1, 2013

Primary CompletionJul 1, 2014

Study CompletionJul 1, 2015

TodayJul 2, 2026

Enrollment to primary: 1.3 yearsPosted 14.1 years ago

Interventions

Dexmedetomidinedrug

loading dose (0.5 mcg/kg i.v.), followed by a continuous basal infusion (0.2-0.7 mcg/kg/hr) with 3 allowable patient-controlled self-boluses per hour (0.25 mcg/kg) each with a 20-minute lock-out. Study infusion up to 5 days.