Predictors of Opioid-Induced Respiratory Depression (OIRD)
United States30 participantsStarted 2015-04
Plain-language 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.
Who can participate
Age range18 Years – 50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* is between 18 and 50 years of age;
* weighs greater than 40 kilograms;
* is American Society Anesthesiologist (ASA) status 1 \[assessment by PI or delegate\];
* has a BMI between 18.0 and 30.0 \[calculated from measured height \& weight\];
* has completed the appropriate fasting periods for solids and liquids prior to the administration of remifentanil
* and has provided written informed consent and is willing to comply with the study procedures.
Exclusion Criteria:
* has a prior or known allergy to lidocaine or similar pharmacologic agents;
* is currently taking any medication other than for birth control;
* is currently participating in, or has recently participated in (discontinued within 30 days prior to this study) in an investigational drug study \[self-reported\];
* has a negative Allen's Test to confirm patency of the collateral artery \[clinical assessment by PI or delegate\];
* has made a whole blood donation or has had at least 450 ml of blood drawn within 8 weeks prior to the study procedure \[self-reported\];
* is female with a positive pregnancy test \[serum or urine\], or is female and is unwilling to use effective birth control between the time of screening and study procedure;
* has anemia \[measured by venous blood gas sample\];
* has a history of sickle cell disease \[self-reported\];
* has a positive urine cotinine or urine drug screen or oral ethanol test \[POC testing\];
* has a history of narcotic or recreational drug addition \…
What they're measuring
1
Hypercapnic Ventilatory Response (HCVR) gradient based upon ETCO2 and Minute Volume