Predictors of Opioid-Induced Respiratory Depression (OIRD)

Completed · Phase 1

Conditions studied: Respiratory Depression

In brief

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.

Key facts

Study ID

NCT02473354

Run by

Duke University

People needed

30

Starts

2015-04-01

Expected to finish

2018-04-29

Last updated by the study team

2020-03-10

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 [self reported by subject in response to questioning by PI or delegate; review of duke electronic medical history record];
• has room air saturation less than 95% by pulse oximetry [measurement by PI or delegate];
• has a clinically significant abnormal EKG [assessment by PI or delegate];
• has a clinically significant abnormal pulmonary function test via spirometry [assessment by PI or delegate];
• has a COHb greater than 3%, or MetHb greater than 2% [measured by venous blood sample co-oximetry];
• is intolerant to a breathing mask apparatus [assessment by PI or delegate];
• has any condition in the opinion of the investigator which would make him or her unsuitable for study participation [assessment by PI or delegate];
• is unwilling or unable to provide informed consent or comply with the study procedures;
• has Rayanud's disease.

Where it is running

• Duke University Health Systems — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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