Hydromorphone Pharmacokinetic-Pharmacodynamic Fingerprint

NCT01123486 | Withdrawn

• 1 other identifier: STU00013543
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain; Ventilatory Depression

Keywords

Intravenous opioids; Patient Controlled Analgesia; volunteer pharmacokinetic-pharmacodynamic study

Outcome Measures

Primary Outcomes (1)

• Opioid induced analgesia

  A combined PK-PD model for hydromorphone induced analgesia (heat pain tolerance) will be developed

  24 hours

Secondary Outcomes (3)

• Opioid induced ventilatory depression

  24 hours

• Opioid induced miosis

  24 hours

• Opioid induced EEG changes

  24 hours

Study Arms (1)

hydromorphone

EXPERIMENTAL

open label single arm pharmacokinetic-pharmacodynamic study

Drug: hydromorphone

Interventions

hydromorphone DRUG

hydromorphone 0.02 mg/kg

Also known as: Dilaudid

hydromorphone

Eligibility Criteria

• Age: 21 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• within 20% of their ideal body weight
• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

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MeSH Terms

Conditions

Pain; Respiratory Insufficiency

Interventions

Hydromorphone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Dhanesh K. Gupta, M.D.

  Departments of Anesthesiology & Neurological Surgery, Northwestern University Feinberg School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology & Neurological Surgery

Study Record Dates

• First Submitted: May 10, 2010
• First Posted: May 14, 2010
• Study Start: January 1, 2015
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: April 22, 2015

Record last verified: 2015-04

Locations

US (1)