Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06344858
Status:
COMPLETED
Last Update Posted:
2024-05-29
First Post:
2024-02-05
Brief Title:
Characterization of the Temporal Profile of the Anti-nociceptive Effect of Ketamine Bolus Measured With ANI
Sponsor:
Pontificia Universidad Catolica de Chile
Organization:
Pontificia Universidad Catolica de Chile
Study Overview
Official Title:
Characterization of the Temporal Profile of the Anti- Nociceptive Effect of an Intravenous Ketamine Bolus Using the Nociception Analgesia Index ANI
Status:
COMPLETED
Status Verified Date:
2024-08
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:
Keta-ANI
Brief Summary:
Ketamine an intravenous anesthetic and analgesic agent has experienced a resurgence in its clinical application particularly in subanesthetic doses The aim of this observational study is to characterize the changes in the Nociception Analgesia Index ANI associated with the administration of an intravenous ketamine bolus using a Pharmacokinetic-Pharmacodynamic PKPD modeling approach The pharmacokinetic parameters of the Domino model will be used to predict ketamine plasma concentrations after the bolus dose An Emax model and a link model assuming a first order rate constant ke0 will be used to fit the data Modeling analysis will use the program NONMEM It is expected to recruit a total of 20 patients between 40 and 80 years ASA I II or III programmed for elective surgery with general anesthesia ANI values will be recorded every 6 seconds for 5 minutes from the bolus dose
Detailed Description:
Ketamine was introduced into clinical practice in 1965 and has been widely used as an intravenous anesthetic and analgesic In recent years there has been a resurgence in its use mainly using low intravenous doses as a multimodal analgesia strategy and attenuation of postoperative hyperalgesia Its use in low doses as an analgesic has also grown in other areas such as in emergency medicine and in patients with chronic pain and neuropathic pain While optimal analgesic doses are not well defined in general the recommended regimens range from 015 to 03 mgkg bolus and infusions from 01 to 03 mgkgh
Target-controlled infusion TCI is an intravenous anesthesia delivery technique that incorporates pharmacokinetic models in pump infusion algorithms to allow obtaining objective-stable concentrations of the drug in the plasma or effect site The TCI mode effect site presents advantages over plasma-to-plasma TCI since plasma concentrations do not have a good correlation with the drugs effect in nonequilibrium scenarios This modality is based on that TCI systems can be instructed to exceed the desired plasma concentration to accelerate the rate at which the drugs effect is achieved For the pharmacokinetic model to perform this the parameter set has to have the ke0 which is the equilibrium constant between the plasma and the effect site This parameter provides the necessary information of the time profile of the drugs effect to the model These models are known as on-site effect models or PKPD models The potential benefit of TCI to site effect is the most accurate titration of the desired effect Moreover these models allow us to better understand the temporal profile of the drug effect
TCI has been used for ketamine administration in various settings including critical care The operating room and studies in neuroscience In routine practice ketamine TCI is performed using the model described by Domino with plasma target concentrations lower than 12 ngml to obtain its anti-nociceptive effect Currently ketamine TCI can only be used in plasma mode since ke0 for its analgesic effect has not been determined
The analgesic monitor PhysioDolorisTM MDoloris Medical Systems SAS Lille France was developed to quantitatively evaluate the effects of nociceptive stimuli on analgesicnociceptive balance the balance between the sympatheticparasympathetic nervous system in the anesthetized patient ANI monitoring provides information on physiological coding and processing of nociceptive stimuli by analyzing the high-frequency component of heart rate variation in relation to respiratory rate During anesthesia the nociception index values reflect whether analgesia is adequate and whether analgesia allows the maintenance of nociception-antinociception balance in which parasympathetic activity predominates over sympathetic This monitoring provides a promising and objective evaluation of nociception
The aim of this observational study was to describe changes in the ANI value associated with the administration of an intravenous ketamine bolus in a group of patients scheduled for elective surgery under general anesthesia
The hypothesis is that the anti-nociceptive effect of the drug can be characterized by changes in ANI associated with the administration of a ketamine bolus Effect-site TCI will be possible by incorporating this information into the available ketamine pharmacokinetic models
Target-controlled infusion TCI is an intravenous anesthesia delivery technique that incorporates pharmacokinetic models in pump infusion algorithms to allow obtaining objective-stable concentrations of the drug in the plasma or effect site The TCI mode effect site presents advantages over plasma-to-plasma TCI since plasma concentrations do not have a good correlation with the drugs effect in nonequilibrium scenarios This modality is based on that TCI systems can be instructed to exceed the desired plasma concentration to accelerate the rate at which the drugs effect is achieved For the pharmacokinetic model to perform this the parameter set has to have the ke0 which is the equilibrium constant between the plasma and the effect site This parameter provides the necessary information of the time profile of the drugs effect to the model These models are known as on-site effect models or PKPD models The potential benefit of TCI to site effect is the most accurate titration of the desired effect Moreover these models allow us to better understand the temporal profile of the drug effect
TCI has been used for ketamine administration in various settings including critical care The operating room and studies in neuroscience In routine practice ketamine TCI is performed using the model described by Domino with plasma target concentrations lower than 12 ngml to obtain its anti-nociceptive effect Currently ketamine TCI can only be used in plasma mode since ke0 for its analgesic effect has not been determined
The analgesic monitor PhysioDolorisTM MDoloris Medical Systems SAS Lille France was developed to quantitatively evaluate the effects of nociceptive stimuli on analgesicnociceptive balance the balance between the sympatheticparasympathetic nervous system in the anesthetized patient ANI monitoring provides information on physiological coding and processing of nociceptive stimuli by analyzing the high-frequency component of heart rate variation in relation to respiratory rate During anesthesia the nociception index values reflect whether analgesia is adequate and whether analgesia allows the maintenance of nociception-antinociception balance in which parasympathetic activity predominates over sympathetic This monitoring provides a promising and objective evaluation of nociception
The aim of this observational study was to describe changes in the ANI value associated with the administration of an intravenous ketamine bolus in a group of patients scheduled for elective surgery under general anesthesia
The hypothesis is that the anti-nociceptive effect of the drug can be characterized by changes in ANI associated with the administration of a ketamine bolus Effect-site TCI will be possible by incorporating this information into the available ketamine pharmacokinetic models
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