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Propofol Effect-Site Target Controlled Infusion in the Obese: Characterization of the Time Profile of Bispectral Index Response

NCT01665079 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2012-08-15

No results posted yet for this study

Summary

The aim of this study is to characterize the Pharmacokinetic/Pharmacodynamic relationship of a single bolus dose of propofol in obese patients and to extract a time to peak effect (t-peak) from the estimated model parameters.

Conditions

Interventions

DRUG

Propofol

Propofol was administered by plasma TCI and a bolus dose was given by setting the initial plasma target between 12-16 μg/ml according to the anesthesiologist criteria. The protocol target range was selected based on previous experience using this model in the obese. After the patients reached this target, propofol infusion was stopped until the patients woke up (BIS\>75). No other drugs were given during this period. Facemask ventilation was assisted only if necessary to maintain SpO2 \> 90%. BIS data and propofol infusion data were automatically recorded every five seconds using the AnestFusor© program. Arterial blood samples of 4 ml for propofol assays were collected at 1, 2, 3, 5, 7 and 10 minutes after the initial bolus dose or until BIS \> 75. After the patient woke up the study was considered finished and propofol infusion was restarted according to the anesthesiologist plan.

Sponsors & Collaborators

  • Universidad del Desarrollo

    lead OTHER

Principal Investigators

  • Pablo O Sepúlveda, MD · Clinica Alemana Universidad del Desarrollo

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • Chile

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01665079 on ClinicalTrials.gov