Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06325033
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-22
First Post:
2024-02-08
Brief Title:
Prospective Validation of the Eleveld Model of Propofol for Procedural Sedation in Adults
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
Official Title:
Prospective Clinical Validation of the Eleveld Pharmacokinetic and Pharmacodynamic Model of Propofol for Procedural Sedation in Adults
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this prospective observational study is to identify effect site concentrations CET of propofol using the Eleveld model for different levels of procedural sedation
The main question it aims to answer is to identify CET propofol using the Eleveld model for different levels of procedural sedation as measured by the modified observers assessment of alertness and sedation score MOAAS and EEG monitoring
Participants vital signs will be monitored according to the departmental protocol Sedation will be administered using Target-Controlled Infusion TCI of propofol administered by effect-site TCI using the Eleveld model and remifentanil administered by effect site TCI using the Eleveld model Target controlled infusion of propofol and remifentanil is according to the departmental protocol The MOAAS score will be noted every 5 minutes or when the target effect site concentration of propofol is altered Depth of sedation will also be monitored using a non-invasive BIS monitor
The main question it aims to answer is to identify CET propofol using the Eleveld model for different levels of procedural sedation as measured by the modified observers assessment of alertness and sedation score MOAAS and EEG monitoring
Participants vital signs will be monitored according to the departmental protocol Sedation will be administered using Target-Controlled Infusion TCI of propofol administered by effect-site TCI using the Eleveld model and remifentanil administered by effect site TCI using the Eleveld model Target controlled infusion of propofol and remifentanil is according to the departmental protocol The MOAAS score will be noted every 5 minutes or when the target effect site concentration of propofol is altered Depth of sedation will also be monitored using a non-invasive BIS monitor
Detailed Description:
Since 2012 procedural sedation practices in Dutch hospitals has taken a huge flight Propofol is the preferred drug of choice for moderate to deep sedation This can be titrated by using pharmacokinetic PK and pharmacodynamic PB models programmed in infusion pumps for target controlled infusion TCI Several PKPD models for TCI propofol are available While most TCI systems incorporate PK or PKPD models for specific patient groups such as adults children or older patients the Eleveld model has been developed for TCI of propofol for general anesthesia and sedation in a broad range of patients In 2021 Vellinga et al published a study on the validation of the Eleveld model in patients undergoing general anesthesia So far the Eleveld model has not been externally validated for the use of procedural sedation in adult patients
The aim of this study is to identify effect-site target concentrations of propofol for the Eleveld model that are associated with moderate to deep sedation levels MOAAS 3-1 and the associated BIS levels in adult patients
The secondary outcomes are time to introduction of the endoscope and the time to reach MOAAS 5 after having stopped TCI propofol The use of vasopressors such as ephedrine phenylephrine or norepinephrine The need for airway maneuvers such as chin lift jaw thrust or nasopharyngeal airway
The purpose of this investigation is to produce normalizing graphs of propofol drug infusion and TCI target concentrations for clinical sedation using the Eleveld TCI model It mirrors the validation study of the Eleveld model The sample size estimation of that study was determined by estimation bounds of the model-based drug concentration prediction accuracy That study used 25 individuals for four groups children non-obese elderly and obese adults Aside from the determination of prediction accuracy of the Eleveld model an important secondary result was normalizing graphs of target concentrations drug infusion and drug effects in clinical practice
The intention of the current investigation is to reproduce the normalizing graphs of TCI targets drug infusion and effects similar to the Eleveld propofol TCI model validation study but targeted to sedation rather than anesthesia The current investigation uses no blood samples so sample size estimation cannot be based on model-based drug concentration prediction accuracy We determined that a sample size similar to the validation study is appropriate and propose allocating 25 patients per group and three groups non-obese elderly and obese adults for a total of 75 individuals
The aim of this study is to identify effect-site target concentrations of propofol for the Eleveld model that are associated with moderate to deep sedation levels MOAAS 3-1 and the associated BIS levels in adult patients
The secondary outcomes are time to introduction of the endoscope and the time to reach MOAAS 5 after having stopped TCI propofol The use of vasopressors such as ephedrine phenylephrine or norepinephrine The need for airway maneuvers such as chin lift jaw thrust or nasopharyngeal airway
The purpose of this investigation is to produce normalizing graphs of propofol drug infusion and TCI target concentrations for clinical sedation using the Eleveld TCI model It mirrors the validation study of the Eleveld model The sample size estimation of that study was determined by estimation bounds of the model-based drug concentration prediction accuracy That study used 25 individuals for four groups children non-obese elderly and obese adults Aside from the determination of prediction accuracy of the Eleveld model an important secondary result was normalizing graphs of target concentrations drug infusion and drug effects in clinical practice
The intention of the current investigation is to reproduce the normalizing graphs of TCI targets drug infusion and effects similar to the Eleveld propofol TCI model validation study but targeted to sedation rather than anesthesia The current investigation uses no blood samples so sample size estimation cannot be based on model-based drug concentration prediction accuracy We determined that a sample size similar to the validation study is appropriate and propose allocating 25 patients per group and three groups non-obese elderly and obese adults for a total of 75 individuals
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None