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

Universidad del Desarrollo

Status and phase: Completed; Phase 4

Conditions: Obesity

Treatments: Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT01665079

Propofol TCI obese

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 14 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Propofol

Experimental group

Description:

14 obese patients(IMC\>35 kg m-2) scheduled for laparoscopic bariatric surgery

Treatment:

Drug: Propofol