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Trial record 31 of 759 for:    region | Chile

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

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ClinicalTrials.gov Identifier: NCT03704285
Recruitment Status : Recruiting
First Posted : October 12, 2018
Last Update Posted : February 28, 2019
Sponsor:
Collaborator:
Pontificia Universidad Catolica de Chile
Information provided by (Responsible Party):
Victor Contreras, Pontificia Universidad Catolica de Chile

Brief Summary:

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.


Condition or disease Intervention/treatment
Anesthesia Burned Operative Wound Drug: Propofol Device: BIS

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.


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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Development of Pharmacokinetic / Pharmacodynamic (pk/pd) Model of Propofol in Patients With Severe Burns
Actual Study Start Date : September 29, 2018
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns
Drug Information available for: Propofol

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 Name: Propofol Intravenous dose

Device: BIS
GeneralAnesthesia maintenance with propofol+remifentanil guided by BIS monitoring.
Other Name: General anesthetic




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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

  4. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adults with Major burns
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03704285


Contacts
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Contact: VICTOR E CONTRERAS, MSN 56223549217 vecontre@uc.cl
Contact: Marcela A Avila, MD 56988376943 maravila7@yahoo.com

Locations
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Chile
Victor Contreras Recruiting
Santiago, Región Metropolitana, Chile, 8420525
Contact: VICTOR CONTRERAS, MSN    56223549217    vecontre@uc.cl   
Contact: Marcela Avila, MD    56988376943    maravila7@yahoo.com   
Sub-Investigator: Luis I Cortinez, MD         
Principal Investigator: Marcela A Avila, MD         
Sponsors and Collaborators
Victor Contreras
Pontificia Universidad Catolica de Chile
Investigators
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Study Director: Luis I Cortinez, MD Pontificia Universidad Catolica de Chile

Publications:
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Responsible Party: Victor Contreras, Co-Investigator. Project Manager of Department of Anesthesiology, Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT03704285     History of Changes
Other Study ID Numbers: 171215006
First Posted: October 12, 2018    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Victor Contreras, Pontificia Universidad Catolica de Chile:
anesthesia
burned
TIVA
propofol

Additional relevant MeSH terms:
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Surgical Wound
Wounds and Injuries
Propofol
Anesthetics, General
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics