Ignite Creation Date:
2024-05-06 @ 12:12 PM
Last Modification Date:
2024-10-26 @ 12:55 PM
Study NCT ID:
NCT03704285
Status:
TERMINATED
Last Update Posted:
2022-03-08
First Post:
2018-10-03
Brief Title:
Development of pkpd Model of Propofol in Patients With Severe Burns
Sponsor:
Victor Contreras MSN
Organization:
Pontificia Universidad Catolica de Chile
Study Overview
Official Title:
Development of Pharmacokinetic Pharmacodynamic pkpd Model of Propofol in Patients With Severe Burns
Status:
TERMINATED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Outbreak COVID 19
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HUAPQ
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 45 per 100000 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
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
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 andor 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
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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None