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Sedation and Physiological Effects of Intranasal Dexmedetomidine in Severe COPD

Sponsor
Dayton VA Medical Center (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT02211118
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
18
Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A variety of medications have been used to treat the anxiety, discomfort, and fear associated with continuous and sudden episodic breathlessness in patients with advanced respiratory disease. Opioids and benzodiazepines, used alone or in combination, are commonly prescribed for this distressing symptom. Clinicians are concerned about the adverse effects of opioids, especially respiratory depression, so they frequently prescribe benzodiazepines. Recent studies have shown that benzodiazepine use is associated with increased adverse respiratory outcomes in older adults with Chronic Obstructive Pulmonary Disease (COPD).

Dexmedetomidine may be an alternative to current drug therapies for breathlessness. Dexmedetomidine produces a dose dependent sedation, anxiolysis, and analgesia without respiratory depression or cognitive dysfunction. The drug can be administered intranasally to induce light to moderate sedation of several hours duration.

The objective of the proposed research, a pilot study, is to assess the dose dependent safety and efficacy of intranasal dexmedetomidine in clinically stable patients with severe COPD. This will be accomplished in a staffed acute care setting with routine vital signs monitoring and pulse oximetry. Patients will be assessed objectively and subjectively for their level of sedation by validated sedation scales.

This pilot study is an initial investigation of a drug with favorable pharmacologic properties in this patient population with distressing and difficult to treat symptoms. The pilot study may provide evidence that a larger trial is needed to confirm the study results, or evidence that additional study in symptomatic patients and treatment comparison trials should be pursued.

Condition or Disease Intervention/Treatment Phase
  • Drug: Intranasal dexemdetomidine (IN-DEX)
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Sedation and Physiological Effects of Intranasal Dexmedetomidine in Severe COPD
Study Start Date :
Oct 1, 2014
Actual Primary Completion Date :
Oct 1, 2015
Actual Study Completion Date :
Apr 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: IN-DEX

Subjects will be administered 1 mcg/kg or 1.5 mcg/kg intranasal dexemdetomidine (IN-DEX) and monitored for up to 5 hours.

Drug: Intranasal dexemdetomidine (IN-DEX)
Other Names:
  • precedex

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Modified Observer's Assessment of Alertness/Sedation Scale [every 15 minutes up to 5 hours after intranasal desmedetomidine]

    2. Sedation Visual Analog Scale (VAS) [Every 15 minutes up to 5 hours after intranasal dexemdetomidine]

    3. Changes in Vital Signs [Every 5 minutes for 90 minutes, then every 15 minutes for up to 5 hours]

      Heart rate, noninvasive blood pressure, respitory rate, pulse oximetry

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Severe COPD (FEV1 30-50% predicted)

    • Age 45-70

    • American Society of Anesthesiologists (ASA) Class 3

    • Body Mass Index <35 kg/meter squared

    • No prior history of adverse reactions to alpha 2 agonists (dexmedetomidine, clonidine)

    • Women of non-child bearing age

    Exclusion Criteria:

    • known adverse reaction, allergy or hypersensitivity, to alpha 2 agonists

    • not nothing by mouth (NPO)

    • ASA class >3

    • Home oxygen therapy >2LPM by nasal cannula continuous use

    • Any evidence of nasal mucosal inflammation, irritation, bleeding or ulceration

    • Pregnancy, or possibility of pregnancy

    • Coronary heart disease with stable or unstable angina

    • Baseline heart rate <55 beats per minute

    • Bradyarrhythmia, heart block, presence of pacemaker

    • Congestive Heart Failure or known Cardiomyopathy (Ejection Fraction <40% by ECHO, MUGA, or myocardial perfusion imaging)

    • Cor pulmonale

    • Liver disease (hepatic transaminases above the upper limit of normal, cirrhosis, end stage liver disease)

    • diagnosis of moderate to severe Obstructive Sleep Apnea

    • currently enrolled in any other research study involving drugs or devices

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dayton VA Medical Center Dayton Ohio United States 45428

    Sponsors and Collaborators

    • Dayton VA Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dayton VA Medical Center
    ClinicalTrials.gov Identifier:
    NCT02211118
    Other Study ID Numbers:
    • Nystrom01
    First Posted:
    Aug 7, 2014
    Last Update Posted:
    Jul 18, 2019
    Last Verified:
    Jul 1, 2019
    Additional relevant MeSH terms:
    Dexmedetomidine

    Study Results

    No Results Posted as of Jul 18, 2019