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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Clinica Alemana

Santiago, Santiago Metropolitan, Chile

About this study

Target controlled infusion (TCI) is a technique to administer intravenous drugs that allows rapid achievement and maintenance of predetermined drug concentrations, either in plasma (Cp) or at the site of effect (Ce).

To characterize the time profile of propofol effect an additional parameter, the equilibration half time between plasma and effect site (T1/2keo) needs to be incorporated in the pharmacokinetic (PK) model.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

IMC > 35 kg m-2
Scheduled for laparoscopic bariatric surgery
ASA I-II patients
Between 20 and 60 yr of age.

Exclusion criteria

Patients with allergy to study drugs
Uncontrolled hypertension
Heart block greater than first degree
Take any drug acting in the central nervous system

Treatment and study plan

Propofol

Drug

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.

Primary outcomes

Profile of Pharmacokinetic and Pharmacodynamic of an induction bolus dose of propofol in obese patients.

Time frame: 1, 2, 3, 5, 7 and 10 minutes after the initial bolus dose or until BIS > 75

Pharmacokinetic parameters (V1, V2, V3, CL, Q)

Pharmacodynamic parameters (E0, Emax, C50, Gamma, t1/2Ke0, T peak )

Sponsors and collaborators

Lead sponsor

Universidad del Desarrollo

Other

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2011
First posted: Aug 15, 2012
Registry last updated: Aug 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed