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

NCT03704285 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2022-03-08

No results posted yet for this study

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.

Conditions

  • Anesthesia
  • Burned
  • Operative Wound

Interventions

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.

DEVICE

BIS

GeneralAnesthesia maintenance with propofol+remifentanil guided by BIS monitoring.

Sponsors & Collaborators

  • Pontificia Universidad Catolica de Chile

    collaborator OTHER

  • Victor Contreras, MSN

    lead OTHER

Principal Investigators

  • Luis I Cortinez, MD · Pontificia Universidad Catolica de Chile

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-29
Primary Completion
2021-12-30
Completion
2021-12-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03704285 on ClinicalTrials.gov