Hydromorphone Pharmacokinetic-Pharmacodynamic Fingerprint
Withdrawn before enrolling · Not applicable
Conditions studied: Pain, Ventilatory Depression
In brief
The primary objective of the proposed work is development of a high resolution pharmacokinetic-pharmacodynamic (PK-PD) model of hydromorphone for experimental pain stimuli, ventilatory depression, and surrogate biomarkers of opioid effect that will allow the fingerprinting of hydromorphone. This fingerprint will serve as the basis for the development of dosing strategies that efficiently maximize analgesia while minimizing ventilatory depression and sedation. For example, this high-resolution fingerprint will allow precise estimation of an initial hydromorphone target effect site concentration (Ce) from those of effectively administered synthetic opioids with previously determined high-resolution fingerprints (i.e., remifentanil or fentanyl), thereby minimizing underdosing of hydromorphone for analgesia and minimizing side effects.
Key facts
- Study ID
- NCT01123486
- Run by
- Northwestern University
- People needed
- 0
- Starts
- 2015-01-01
- Expected to finish
- 2015-01-01
- Last updated by the study team
- 2015-04-22
Who can join
Age: 21 and older, up to 30. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- within 20% of their ideal body weight
- 21-30 years old
- ASA I (no systemic disease)
- No history of PONV (except wisdom teeth extraction)
- No long term medication use
- No history of coagulation defect (i.e easy bruising, gum bleeding with teeth brushing, frequent nose bleeds, past documented coagulopathy, etc.)
You may not qualify if…
- Inability to place an arterial line
- A failed urine drug test on admission to the CRU
- A positive pregnancy test on admission to the CRU
- A hemoglobin level < 12.5 g/dL on admission to the CRU
Where it is running
- Northwestern Memorial Hospital — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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