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

NCT01665079 | Completed Phase 4 DMC

• 1 other identifier: Propofol TCI obese
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

anaesthetics iv; propofol; pharmacokinetics; pharmacodynamic

Outcome Measures

Primary Outcomes (1)

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

  Pharmacokinetic parameters (V1, V2, V3, CL, Q) Pharmacodynamic parameters (E0, Emax, C50, Gamma, t1/2Ke0, T peak )

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

Study Arms (1)

Propofol

EXPERIMENTAL

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

Drug: Propofol

Interventions

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.

Propofol

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad del Desarrollo: lead

Study Sites (1)

Clinica Alemana

Santiago, Santiago Metropolitan, Chile

Location

Related Publications (1)

• 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.

  PMID: 29401079 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Propofol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Pablo O Sepúlveda, MD

  Clinica Alemana Universidad del Desarrollo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Profesor Asociado Anestesiología

Study Record Dates

• First Submitted: August 9, 2012
• First Posted: August 15, 2012
• Study Start: April 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: August 15, 2012

Record last verified: 2012-08

Locations

CL (1)