Hydromorphone Pharmacokinetic-Pharmacodynamic Fingerprint

• Status: Withdrawn
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Northwestern University
• Treatments: Hydromorphone

Criteria

Inclusion Criteria:

• 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.)

Exclusion Criteria:

• 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