Performance of Two Different ke0s in the Same Pharmacokinetic Propofol Model

This study has been completed.
Sponsor:
Collaborator:
Hospital Santa Sofia Ltda
Information provided by:
Centro Medico Campinas
ClinicalTrials.gov Identifier:
NCT01011192
First received: November 10, 2009
Last updated: November 12, 2009
Last verified: November 2009
  Purpose

The aim of this study was to assess the clinical performance of two different ke0s (fast and slow) in terms of propofol effect-site concentration (Ce) during the loss and recovery of consciousness, using Marsh's pharmacokinetic model.The hypothesis to be tested was that the Ce of propofol predicted by the slow ke0 in the loss and recovery of consciousness is similar, differently from the fast ke0.


Condition
Unconsciousness

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Performance of Two Different Ke0s in the Same Pharmacokinetic Propofol Model. Study on Loss and Recovery of Consciousness

Resource links provided by NLM:


Further study details as provided by Centro Medico Campinas:

Primary Outcome Measures:
  • Propofol effect-site concentration (Ce) during the loss and recovery of consciousness with fast and slow keo. [ Time Frame: 20 minutes ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: September 2009
Study Completion Date: November 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
ke0 of 0.26 min-1
Individual volunteers using Marsh's pharmacokinetic target-controlled infusion model with ke0 of 0.26 min-1 (Asena PK® - Cardinal Health)
ke0 of 1.21 min-1
Individual volunteers using Marsh's pharmacokinetic target-controlled infusion model with ke0 of 1.21 min-1 (Primea Orchestra® - Fresenius-Kabi basis)

Detailed Description:

Introduction: The ke0 can be defined as the proportional variation of the gradient of concentration between the plasma and the effect-site in relation to the unit of time. Theoretically, the higher the value of the ke0, the faster the drug enters the effect-site. Therefore, drugs with short T½ke0 have high ke0s and fast onset of action. The aim of this study was to assess the clinical performance of two different ke0s (fast and slow) in terms of propofol effect-site concentration (Ce) during the loss and recovery of consciousness, using Marsh's pharmacokinetic model. Method: Twenty healthy male adult volunteers participated in this study. Propofol was first administered to the individual volunteer using Marsh's pharmacokinetic target-controlled infusion model with ke0 of 1.21 min-1 and, on another opportunity, with the same pharmacokinetic model but ke0 of 0.26 min-1. Propofol was infused in plasma target-concentration of 3.0 µg.mL-1. Loss and recovery of consciousness was defined as response of the volunteer to verbal stimulus. The Ce was registered at the moments of loss and recovery of consciousness. Results: At loss and recovery of consciousness, propofol Ce means predicted by the fast ke0 were different (3.64 ± 0.78 and 1.47 ± 0.29 µg.mL-1, respectively, p < 0.0001), whereas with the slow ke0 the predicted Ce means were similar (2.20 ± 0.70 and 2.13 ± 0.43 µg.mL-1, respectively, p = 0.5425). Conclusion: It can be concluded that slow ke0 (0.26 min-1) incorporated into Marsh's pharmacokinetic model showed better clinical performance than fast ke0 (1.21 min-1), since the predicted effect-site concentrations of propofol at loss and recovery of consciousness were similar.

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Twenty healthy male adult volunteers participated in this study. The volunteers appeared at the testing location, having refrained from eating and drinking for six hours. All the volunteers were monitored with electrocardiogram (DII and V1 derivation), pulse oximetry (SpO2), non-invasive average arterial pressure and bispectral index (BIS). Oxygen under 2.0 L.min-1 nasal catheter was used and the left antecubital vein was punctured and connected to the venous catheter filled with propofol (Propovan® - Cristália Laboratório Ltda).

Criteria

Inclusion Criteria:

  • healthy
  • male
  • adult between 20 and 45 years old

Exclusion Criteria:

  • use of alcohol or illicit drugs
  • chronic use of H2 inhibitors and tricyclic antidepressants of calcium channel blockers
  • hypersensitivity to the drugs used in the experimental protocol.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01011192

Locations
Brazil
Hospital Santa Sofia
Campinas, São Paulo, Brazil, 13013161
Sponsors and Collaborators
Centro Medico Campinas
Hospital Santa Sofia Ltda
Investigators
Principal Investigator: Ricardo F Simoni, MD Centro Medico Campinas
  More Information

Publications:
Responsible Party: Eduardo Tadeu Moraes Santos, Hospital Santa Sofia Ltda
ClinicalTrials.gov Identifier: NCT01011192     History of Changes
Other Study ID Numbers: RFS 02
Study First Received: November 10, 2009
Last Updated: November 12, 2009
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Centro Medico Campinas:
Intravenous anesthesia
propofol
pharmacokinetic model
Monitoring
bispectral index.

Additional relevant MeSH terms:
Unconsciousness
Consciousness Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Propofol
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014