Predictors of Opioid-Induced Respiratory Depression (OIRD)
Condition: Respiratory Depression
MeSH terms: Respiratory Insufficiency; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      Purpose of the Study: (1) To classify an individual subject's ventilatory response in terms
      of respiratory depression to a bolus of remifentanil under normoxic and hyperoxic conditions.
      (2) Measurement of specific respiratory parameters to predict the opioid-induced respiratory
      depression (OIRD) response.
    

Detailed description: 
      This study is using FDA approved drugs (remifentanil, oxygen and carbon dioxide) in an
      investigational manner and the study is also developing a diagnostic test that is currently
      investigational. Investigational means that the FDA has not approved the use of the drugs in
      this manner or the diagnostic test being developed.

      Opioid-Induced Respiratory Depression (OIRD) is recognized as potentially life threatening
      and the cause of substantial morbidity (poor health) and mortality (death). Respiratory
      depression is when the amount of breathing you do in a minute falls below normal. Opioids are
      medications widely used to treat both acute (lasting hours to days) and chronic (lasting
      months) pain, both within and outside the hospital setting. Opioids have been used outside
      the prescribed circumstances resulting in misuse and abuse. Even within the controlled
      environment of acute hospital care it is difficult to identify those individuals at most risk
      of OIRD, as many do not possess physical characteristics, such as obesity or obstructive
      sleep apnea (stop breathing during sleep), which may predispose to OIRD. In the absence of
      the ability to easily identify at-risk individuals the Anesthesia Patient Safety Foundation
      have suggested that all patients receiving opioids must be considered at risk of OIRD and
      therefore require appropriate monitoring.

      Even when fully awake, the normal response to breathing a gas mixture containing carbon
      dioxide (CO2) is to increase the amount of breathing. The effect is similar to breathing in
      and out of a paper bag. This is called the Hypercapnic Ventilatory Response (HCVR) and can be
      measured. Not everyone responds in an identical manner - there will be differences in the
      HCVR from one person to the next. But if an individual's baseline HCVR is measured, then the
      change from baseline can also be measured.

      This study is being done to: (1) classify or rate an individual subject's ventilatory
      (breathing) response in terms of respiratory depression to a bolus of a potent opioid
      (similar to morphine, often referred to as a narcotic). The opioid used for this study is
      Remifentanil and is commonly used in the operating room. Remifentanil will be given under
      normoxic (breathing room air [21% Oxygen]) and hyperoxic (breathing 50% oxygen) conditions to
      (2) determine if the measurement of the specific respiratory parameters will predict the OIRD
      response.
    

Intervention name(s): Remifentanil; Oxygen; Carbon dioxide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The opioid used for this study is Remifentanil and is commonly used in the operating room. Remifentanil will be given under normoxic (breathing room air [21% Oxygen]) and hyperoxic (breathing 50% oxygen) conditions to determine if the measurement of the specific respiratory parameters will predict the OIRD response.; Remifentanil will be administered under normal oxygen (normoxia) and increased oxygen (hyperemic) conditions.; Carbon dioxide is used as part of the hypercapnia ventilatory response measurement (HCVR)
Other intervention name(s): O2; CO2
Intervention MeSH terms: Remifentanil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research