Predictors of Opioid-Induced Respiratory Depression (OIRD)

• Status: Completed
• Trial end date: 2018-04-29
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Duke University
• Treatments: Analgesics, Opioid; Remifentanil

Criteria

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 [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.