Performance of Two Different ke0s in the Same Pharmacokinetic Propofol Model

NCT01011192 | Completed DMC

• 1 other identifier: RFS 02
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Unconsciousness

Keywords

Intravenous anesthesia; propofol; pharmacokinetic model; Monitoring; bispectral index.

Outcome Measures

Primary Outcomes (1)

• Propofol effect-site concentration (Ce) during the loss and recovery of consciousness with fast and slow keo.

  20 minutes

Study Arms (2)

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)

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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).

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro Medico Campinas: lead
• Hospital Santa Sofia Ltda: collaborator

Study Sites (1)

Hospital Santa Sofia

Campinas, São Paulo, 13013161, Brazil

Location

Related Publications (1)

• Iwakiri H, Nishihara N, Nagata O, Matsukawa T, Ozaki M, Sessler DI. Individual effect-site concentrations of propofol are similar at loss of consciousness and at awakening. Anesth Analg. 2005 Jan;100(1):107-110. doi: 10.1213/01.ANE.0000139358.15909.EA.

  PMID: 15616062 RESULT

MeSH Terms

Conditions

Unconsciousness

Condition Hierarchy (Ancestors)

Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ricardo F Simoni, MD

  Centro Medico Campinas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 10, 2009
• First Posted: November 11, 2009
• Study Start: September 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: November 1, 2009
• Last Updated: November 13, 2009

Record last verified: 2009-11

Locations

BR (1)