Sedation and Physiological Effects of Intranasal Dexmedetomidine in Severe COPD

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.

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Key information

Conditions

COPD Chronic Disease Dexmedetomidine Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Sedation

Age range

45 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dayton VA Medical Center

Dayton, Ohio, 45428, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intranasal dexemdetomidine (IN-DEX)

Drug

Other names: precedex

Primary outcomes

Modified Observer's Assessment of Alertness/Sedation Scale

Time frame: every 15 minutes up to 5 hours after intranasal desmedetomidine
Sedation Visual Analog Scale (VAS)

Time frame: Every 15 minutes up to 5 hours after intranasal dexemdetomidine
Changes in Vital Signs

Time frame: Every 5 minutes for 90 minutes, then every 15 minutes for up to 5 hours

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

Sponsors and collaborators

Lead sponsor

Dayton VA Medical Center

Fed

Registry information

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2016
First posted: Aug 7, 2014
Registry last updated: Jul 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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