Development of pk/pd Model of Propofol in Patients With Severe Burns (HUAPQ)

March 7, 2022 updated by: Victor Contreras, MSN

Development of Pharmacokinetic / Pharmacodynamic (pk/pd) Model of Propofol in Patients With Severe Burns

Burn injuries are a prevalent problem. Actually, in Chile the Ministry of Health has recorded 6435 hospital burns and has reported 569 deaths from this cause. The specific mortality rate for burning in Chile was 4.5 per 100,000 inhabitants per year. Survival in extensive burns has progressively improved, thanks to advances in understanding the pathophysiology of the burn and its more aggressive treatment. This requires effective prehospital treatment, transportation, resuscitation, support of vital functions and repair of the skin cover.

Much of the procedures performed in large burns require general anesthesia. Being Total Intravenous Anesthesia (TIVA) with propofol an alternative that would have advantages over inhalational anesthesia, as a decrease in postoperative nausea and vomiting and produce less environmental pollution 3 and the antihyperalgesic effect of propofol. Within TIVA - Target Control Infusion (TCI) - uses infusion systems that incorporate PK-PD models for predict the dose of drug required to reach a certain concentration in the target organ.

The formulation of a PK model that considers the variables of this group of patients, such as: degree of injury, inflammatory state and compromised body surface; associated with general variables such as: age, weight and nutrition, it would allow to reduce the predictive error in this population, thus improving the dosing of these patients when using TCI.

Given the lack evidence on the PK-PD of propofol is this group of patients burned, has led to raise the development of this study that seeks to develop a PK-PD model that fits them.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Patients will be invited to participate before surgery, the inclusion criteria will be revised and the informed consent will be signed.

In the operating room will be recorded demographic data and relevant background such as: Age, Weight, Size, BMI, Lean Mass, Fat Mass and Total body water among others.

Afterwards, in the operating room, the patient will be monitored regularly: ECG (DII) if feasible and pulse oximetry. An arterial catheter will be installed for monitoring and taking blood samples during the intraoperative period.

In addition, the EEG will be monitored through a frontal electroencephalographic monitoring (BIS) system; that will be recorded throughout the surgery.

The anesthetic induction will be with propofol and remifentanil. The propofol will be administered using an initial bolus of 1-2 mg / kg according to the criteria of the anesthetist and then a continuous infusion of 10 mg / kg / hr that will be adjusted adjusted to maintain a BIS between 40 and 60.

Plasma samples of propofol: arterial samples of 3-4 ml will be taken at 2, 5, 10, 30, 60 and/or 120 min after beginning the administration of propofol. Subsequently samples will be taken at 0, 5, 15, 30, 60, 120, 240 min and at 6-12 hrs after stopping the infusion of propofol. The samples will be centrifuged and stored at -20 ° C until analysis by HPLC.

Study Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • Región Metropolitana
      • Santiago, Región Metropolitana, Chile, 8420525
        • Victor Contreras

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults with Major burns

Description

Inclusion Criteria:

  • Severe burns with life risk that require treatment in Burn Units and / or Critical Patient Units.
  • In spontaneous ventilation
  • SAS 4

Exclusion Criteria:

  • Electric burns
  • ASA IV o V
  • Inability to install BIS

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Propofol
Severe burn adult under general anesthesia with propofol + remifentanil evaluation of propofol effect using BIS
Drug: Propofol
Patients undergoing general anesthesia using target controlled infusion of propofol. Initial bolus of 1-2 mg/kg and then a continuous infusion of 10 mg/kg/hr that will be adjusted adjusted to maintain a BIS between 40 and 60.
Other Names:
  • Propofol Intravenous dose
Device: BIS
GeneralAnesthesia maintenance with propofol+remifentanil guided by BIS monitoring.
Other Names:
  • General anesthetic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Propofol plasmatic levels Measured by high pressure liquid chromatography
Time Frame: From start of propofol infusion to 12 hrs after stopped infusion of propofol.
Propofol total dose. 2, 5, 10, 30, 60 and 120 min after induction with propofol. Subsequently, samples will be taken at 0, 5, 15, 30, 60, 120, 240 min and at 6-12 hrs after stopping infusion of propofol.
From start of propofol infusion to 12 hrs after stopped infusion of propofol.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BIS
Time Frame: Every 5 min. Since entering operating room up to end of anesthesia and leaving to recovery room. In average 2 hrs.
Depth of anesthesia will be recorded with BIS monitor. From 60 - 40
Every 5 min. Since entering operating room up to end of anesthesia and leaving to recovery room. In average 2 hrs.
Hemodynamics
Time Frame: Every 5 min. Since entering operating room up to end of anesthesia and leaving to recovery room. In average 2 hrs.
Arterial pressure (mmHg)
Every 5 min. Since entering operating room up to end of anesthesia and leaving to recovery room. In average 2 hrs.
Heart Rate
Time Frame: Every 5 min. Since entering operating room up to end of anesthesia and leaving to recovery room. In average 2 hrs.
Heart rate (bpm)
Every 5 min. Since entering operating room up to end of anesthesia and leaving to recovery room. In average 2 hrs.
Pulse oximetry
Time Frame: Every 5 min. Since entering operating room up to end of anesthesia and leaving to recovery room. In average 2 hrs.
% oximetry saturation
Every 5 min. Since entering operating room up to end of anesthesia and leaving to recovery room. In average 2 hrs.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Victor Contreras, MSN

Collaborators

Pontificia Universidad Catolica de Chile

Investigators

  • Study Director: Luis I Cortinez, MD, Pontificia Universidad Catolica de Chile

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2018

Primary Completion (Actual)

December 30, 2021

Study Completion (Actual)

December 30, 2021

Study Registration Dates

First Submitted

October 3, 2018

First Submitted That Met QC Criteria

October 9, 2018

First Posted (Actual)

October 12, 2018

Study Record Updates

Last Update Posted (Actual)

March 8, 2022

Last Update Submitted That Met QC Criteria

March 7, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 171215006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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