Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06237101
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-08
First Post:
2024-01-24
Brief Title:
Remifentanil Effect on Burst Suppression Ratio
Sponsor:
University of Chile
Organization:
University of Chile
Study Overview
Official Title:
Influence of Variable Plasma Concentrations of Remifentanil on Burst Suppression BS Event Rate in Electroencephalographic EEG Recordings of Human Subjects Undergoing Total Intravenous General Anesthesia TIVA Under Propofol
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
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 clinical trial is to determine whether remifentanil has a facilitating effect on the generation of burst suppression by propofol in adult patients 18-60 years candidates for elective surgery who require remifentanil and American Society of Anesthesiology ASA classification I or II The main question it aims to answer are
To determine whether remifentanil has a facilitating effect on the generation of burst suppression by propofol
Participants will undergo general anesthesia with remifentanil and propofol sequentially After loss of consciousness remifentanil will be adjusted to a medium or high concentration randomly and it will be determined at what concentration of propofol the burst suppressions are generated
Then the concentrations of propofol that generate burst suppression associated with either a medium or high concentration of remifentanil will be compared
To determine whether remifentanil has a facilitating effect on the generation of burst suppression by propofol
Participants will undergo general anesthesia with remifentanil and propofol sequentially After loss of consciousness remifentanil will be adjusted to a medium or high concentration randomly and it will be determined at what concentration of propofol the burst suppressions are generated
Then the concentrations of propofol that generate burst suppression associated with either a medium or high concentration of remifentanil will be compared
Detailed Description:
Subjects will enter the ward after which an 18 G intravenous cannula will be installed and will be monitored under the routinely applied ASA standard Frontal EEG activity will be recorded using an anesthetic depth monitor and a baseline EEG will be recorded for 120 seconds with eyes closed Subjects will then be preoxygenated Once the oxygen concentration at the end of expiration reaches 90 the administration of remifentanil will begin under the Minto pharmacological model to reach an effect site concentration of 75 ngmL Once the remifentanil concentration is reached the infusion of propofol will begin at a rate of 15 mgkgh using Base Primea Orchestra until loss of consciousness LOC is achieved LOC will be defined as loss of response to verbal and tactile stimulation which will be corroborated every 30 seconds After this the propofol infusion will be maintained at the concentration at which the LOC occurred based on Marshs pharmacological model and rocuronium 06 mgkg will be administered to facilitate orotracheal intubation
Once the patient has been intubated the remifentanil will be lowered to a concentration of 4 ngmL and the surgery will continue After 5 min after the LOC occurred according to randomization the concentration of remifentanil will remain at 4 ngmL or increase to 75 ngmL and 10 min after the LOC occurred the propofol infusion rate will be changed to 15 mgkgh for 10 min After this the propofol concentration at which the LOC occurred will be returned and remifentanil will be maintained at 4 ngmL After 5 min after completing the previous step remifentanil will be increased to 75 ngmL or maintained at 4 ngmL in the opposite way to what happened previously After 10 min after completing the previous step propofol will be dosed again at a fixed rate of 15 mgkgh for 10 min Finally after this time has elapsed the concentration of propofol at which the LOC occurred will be returned and the remifentanil will be dosed according to the surgical requirements Throughout the protocol hemodynamics will be maintained with the usual management of drugs such as ephedrine in boluses or norepinephrine in continuous infusion
Once the patient has been intubated the remifentanil will be lowered to a concentration of 4 ngmL and the surgery will continue After 5 min after the LOC occurred according to randomization the concentration of remifentanil will remain at 4 ngmL or increase to 75 ngmL and 10 min after the LOC occurred the propofol infusion rate will be changed to 15 mgkgh for 10 min After this the propofol concentration at which the LOC occurred will be returned and remifentanil will be maintained at 4 ngmL After 5 min after completing the previous step remifentanil will be increased to 75 ngmL or maintained at 4 ngmL in the opposite way to what happened previously After 10 min after completing the previous step propofol will be dosed again at a fixed rate of 15 mgkgh for 10 min Finally after this time has elapsed the concentration of propofol at which the LOC occurred will be returned and the remifentanil will be dosed according to the surgical requirements Throughout the protocol hemodynamics will be maintained with the usual management of drugs such as ephedrine in boluses or norepinephrine in continuous infusion
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?:
False
Is an FDA AA801 Violation?:
None