CompletedPhase 1

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 range

18 Years – 50 Years

Sex

ALL

See this in plain English?

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 \…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Hypercapnic Ventilatory Response (HCVR) gradient based upon ETCO2 and Minute Volume

Timeframe: Sequence #1 approximately 30 minutes

Trial details

NCT IDNCT02473354

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-04-29

View on ClinicalTrials.gov More Respiratory Depression trials