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

NCT ID: NCT01665079

Last Updated: 2012-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2011-11-30

Brief 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.

Detailed 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.

Conditions

Obesity

Keywords

anaesthetics iv; propofol; pharmacokinetics; pharmacodynamic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Propofol

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

Group Type: EXPERIMENTAL

Propofol

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad del Desarrollo

OTHER

Sponsor Role: lead

Responsible Party

Pablo Sepulveda

Profesor Asociado Anestesiología

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pablo O Sepúlveda, MD

Role: PRINCIPAL_INVESTIGATOR

Clinica Alemana Universidad del Desarrollo

Locations

Clinica Alemana

Santiago, Santiago Metropolitan, Chile

Countries

Chile

References

Cortinez LI, Sepulveda P, Rolle A, Cottin P, Guerrini A, Anderson BJ. Effect-Site Target-Controlled Infusion in the Obese: Model Derivation and Performance Assessment. Anesth Analg. 2018 Oct;127(4):865-872. doi: 10.1213/ANE.0000000000002814.

Reference Type: DERIVED

PMID: 29401079 (View on PubMed)

Other Identifiers

Propofol TCI obese

Identifier Type: -

Identifier Source: org_study_id