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| Name | Class |
|---|---|
| University Medical Center Groningen | OTHER |
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This is an interventional, randomized controlled study in health volunteers that involves collecting data on raw EEG waves measuring various combinations of anesthetic drugs during standardized drug titration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Volunteers | Experimental | All healthy volunteers will receive four sessions of anesthesia with different common drug combinations while having SedLine EEG sensors placed on their forehead during these sessions to study the effects of these drugs on the brain. The sessions were: propofol (P), sevoflurane (S), propofol with remifentanil (PR), and sevoflurane with remifentanil (SR). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SedLine EEG sensor | Device | Test subjects in each group will receive the same device intervention (SedLine EEG) to monitor their EEG waves. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient State Index (PSI) Comparison, Baseline and Emax | Patient State Index (PSI-1) is a processed EEG parameter that quantifies the level of EEG inhibition. A new algorithm (PSI-2) has been created to improve performance in low power EEG. PSI is unitless. It ranges between 100 and 0 (100 representing 'awake state', 0 denoting 'no detectable electrical brain activity'). PSI-1 and PSI-2 were compared in their correlation with measured propofol and sevoflurane concentrations with or without remifentanil (0, 2 ,or 4 ng/mL) via several estimated PD model parameters. In the data table, BL (Baseline) denotes PSI-2 measurements when no drug is present; Emax denotes PSI in the presence of the maximum drug effect; C50 is the drug concentration which produces 50% of the maximal drug effect (ug/mL for Propofol C50, vol% for Sevoflurane C50). | 6 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Patient State Index (PSI) Comparison, C50 (Sevoflurane, Sevoflurane+Remifentanil) | Patient State Index (PSI-1) is a processed EEG parameter that quantifies the level of EEG inhibition. A new algorithm (PSI-2) has been created to improve performance in low power EEG. PSI is unitless. It ranges between 100 and 0 (100 representing 'awake state', 0 denoting 'no detectable electrical brain activity'). PSI-1 and PSI-2 were compared in their correlation with measured propofol and sevoflurane concentrations with or without remifentanil (0, 2 ,or 4 ng/mL) via several estimated PD model parameters. In the data table, BL (Baseline) denotes PSI-2 measurements when no drug is present; Emax denotes PSI in the presence of the maximum drug effect; C50 is the drug concentration which produces 50% of the maximal drug effect (ug/mL for Propofol C50, vol% for Sevoflurane C50). |
Inclusion Criteria:
Exclusion Criteria:
Volunteer refusal
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Groningen | Groningen | 9713EZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37355412 | Derived | Su H, Koomen JV, Eleveld DJ, Struys MMRF, Colin PJ. Pharmacodynamic mechanism-based interaction model for the haemodynamic effects of remifentanil and propofol in healthy volunteers. Br J Anaesth. 2023 Aug;131(2):222-233. doi: 10.1016/j.bja.2023.04.043. Epub 2023 Jun 22. | |
| 35249706 | Derived | Su H, Eleveld DJ, Struys MMRF, Colin PJ. Mechanism-based pharmacodynamic model for propofol haemodynamic effects in healthy volunteers☆. Br J Anaesth. 2022 May;128(5):806-816. doi: 10.1016/j.bja.2022.01.022. Epub 2022 Mar 3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Volunteers | Thirty-six healthy volunteers received four sessions of anesthesia with different common drug combinations while having SedLine EEG sensors placed on their forehead during these sessions to study the effects of these drugs on the brain. The sessions were: propofol (P), sevoflurane (S), propofol with remifentanil (PR), and sevoflurane with remifentanil (SR). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Volunteers | Thirty-six healthy volunteers received four sessions of anesthesia with different common drug combinations while having SedLine EEG sensors placed on their forehead during these sessions to study the effects of these drugs on the brain. The sessions were: propofol (P), sevoflurane (S), propofol with remifentanil (PR), and sevoflurane with remifentanil (SR). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient State Index (PSI) Comparison, Baseline and Emax | Patient State Index (PSI-1) is a processed EEG parameter that quantifies the level of EEG inhibition. A new algorithm (PSI-2) has been created to improve performance in low power EEG. PSI is unitless. It ranges between 100 and 0 (100 representing 'awake state', 0 denoting 'no detectable electrical brain activity'). PSI-1 and PSI-2 were compared in their correlation with measured propofol and sevoflurane concentrations with or without remifentanil (0, 2 ,or 4 ng/mL) via several estimated PD model parameters. In the data table, BL (Baseline) denotes PSI-2 measurements when no drug is present; Emax denotes PSI in the presence of the maximum drug effect; C50 is the drug concentration which produces 50% of the maximal drug effect (ug/mL for Propofol C50, vol% for Sevoflurane C50). | All 36 participants experienced all four interventions: Propofol only (P), Sevoflurane only (S), Propofol with Remifentanil (PR), and Sevoflurane with Remifentanil (SR). | Posted | Mean | Standard Error | index | 6 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Volunteers, Propofol (P) | Thirty-six healthy volunteers received four sessions of anesthesia with different common drug combinations while having SedLine EEG sensors placed on their forehead during these sessions to study the effects of these drugs on the brain. The sessions were: propofol (P), sevoflurane (S), propofol with remifentanil (PR), and sevoflurane with remifentanil (SR). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | General disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vikram Ramakanth | Masimo | clinicalresearchdept@masimo.com |
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| 6 weeks |
| Patient State Index (PSI) Comparison, C50 (Propofol, Propofol+Remifentanil) | Patient State Index (PSI-1) is a processed EEG parameter that quantifies the level of EEG inhibition. A new algorithm (PSI-2) has been created to improve performance in low power EEG. PSI is unitless. It ranges between 100 and 0 (100 representing 'awake state', 0 denoting 'no detectable electrical brain activity'). PSI-1 and PSI-2 were compared in their correlation with measured propofol and sevoflurane concentrations with or without remifentanil (0, 2 ,or 4 ng/mL) via several estimated PD model parameters. In the data table, BL (Baseline) denotes PSI-2 measurements when no drug is present; Emax denotes PSI in the presence of the maximum drug effect; C50 is the drug concentration which produces 50% of the maximal drug effect (ug/mL for Propofol C50, vol% for Sevoflurane C50). | 6 weeks |
| Propofol, Sevoflurane, and Remifentanil Interaction. | For all study groups (i.e. P, S, PR, and SR), the estimated PD model parameters that represent remifentanil interactions are Theta1 and Theta2, which are unit-less values. Theta1 and Theta2 are zero for all volunteers not receiving remifentanil. In case an interaction between remifentanil and propofol or sevoflurane exists, the estimate for Theta1 will be significantly different from zero. If the interaction in the 4 ng/mL group exceeds the estimated interaction for the 2 ng/mL group, Theta2 will be significantly higher than zero. | 6 weeks |
| 33315176 | Derived | Ramaswamy SM, Kuizenga MH, Weerink MAS, Vereecke HEM, Struys MMRF, Belur Nagaraj S. Frontal electroencephalogram based drug, sex, and age independent sedation level prediction using non-linear machine learning algorithms. J Clin Monit Comput. 2022 Feb;36(1):121-130. doi: 10.1007/s10877-020-00627-3. Epub 2020 Dec 14. |
| 31326088 | Derived | Ramaswamy SM, Kuizenga MH, Weerink MAS, Vereecke HEM, Struys MMRF, Nagaraj SB. Novel drug-independent sedation level estimation based on machine learning of quantitative frontal electroencephalogram features in healthy volunteers. Br J Anaesth. 2019 Oct;123(4):479-487. doi: 10.1016/j.bja.2019.06.004. Epub 2019 Jul 18. |
| 29452809 | Derived | Kuizenga MH, Colin PJ, Reyntjens KMEM, Touw DJ, Nalbat H, Knotnerus FH, Vereecke HEM, Struys MMRF. Test of neural inertia in humans during general anaesthesia. Br J Anaesth. 2018 Mar;120(3):525-536. doi: 10.1016/j.bja.2017.11.072. Epub 2017 Dec 1. |
| Investigator decision |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG000 |
| Healthy Volunteers |
Thirty-six healthy volunteers received four sessions of anesthesia with different common drug combinations while having SedLine EEG sensors placed on their forehead during these sessions to study the effects of these drugs on the brain. The sessions were: propofol (P), sevoflurane (S), propofol with remifentanil (PR), and sevoflurane with remifentanil (SR). |
|
|
| Other Pre-specified | Patient State Index (PSI) Comparison, C50 (Sevoflurane, Sevoflurane+Remifentanil) | Patient State Index (PSI-1) is a processed EEG parameter that quantifies the level of EEG inhibition. A new algorithm (PSI-2) has been created to improve performance in low power EEG. PSI is unitless. It ranges between 100 and 0 (100 representing 'awake state', 0 denoting 'no detectable electrical brain activity'). PSI-1 and PSI-2 were compared in their correlation with measured propofol and sevoflurane concentrations with or without remifentanil (0, 2 ,or 4 ng/mL) via several estimated PD model parameters. In the data table, BL (Baseline) denotes PSI-2 measurements when no drug is present; Emax denotes PSI in the presence of the maximum drug effect; C50 is the drug concentration which produces 50% of the maximal drug effect (ug/mL for Propofol C50, vol% for Sevoflurane C50). | All 36 participants experienced all four interventions: Propofol only (P), Sevoflurane only (S), Propofol with Remifentanil (PR), and Sevoflurane with Remifentanil (SR). | Posted | Mean | Standard Error | %vol | 6 weeks |
|
|
|
| Other Pre-specified | Patient State Index (PSI) Comparison, C50 (Propofol, Propofol+Remifentanil) | Patient State Index (PSI-1) is a processed EEG parameter that quantifies the level of EEG inhibition. A new algorithm (PSI-2) has been created to improve performance in low power EEG. PSI is unitless. It ranges between 100 and 0 (100 representing 'awake state', 0 denoting 'no detectable electrical brain activity'). PSI-1 and PSI-2 were compared in their correlation with measured propofol and sevoflurane concentrations with or without remifentanil (0, 2 ,or 4 ng/mL) via several estimated PD model parameters. In the data table, BL (Baseline) denotes PSI-2 measurements when no drug is present; Emax denotes PSI in the presence of the maximum drug effect; C50 is the drug concentration which produces 50% of the maximal drug effect (ug/mL for Propofol C50, vol% for Sevoflurane C50). | All 36 participants experienced all four interventions: Propofol only (P), Sevoflurane only (S), Propofol with Remifentanil (PR), and Sevoflurane with Remifentanil (SR). | Posted | Mean | Standard Error | ug/mL | 6 weeks |
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|
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| Other Pre-specified | Propofol, Sevoflurane, and Remifentanil Interaction. | For all study groups (i.e. P, S, PR, and SR), the estimated PD model parameters that represent remifentanil interactions are Theta1 and Theta2, which are unit-less values. Theta1 and Theta2 are zero for all volunteers not receiving remifentanil. In case an interaction between remifentanil and propofol or sevoflurane exists, the estimate for Theta1 will be significantly different from zero. If the interaction in the 4 ng/mL group exceeds the estimated interaction for the 2 ng/mL group, Theta2 will be significantly higher than zero. | 18 participants experienced the remifentanil 2 ng/mL intervention, and 18 participants experienced the remifentanil 4 ng/mL intervention. | Posted | Mean | Standard Error | Index | 6 weeks |
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| 0 |
| 36 |
| 0 |
| 36 |
| 1 |
| 36 |
| EG001 | Healthy Volunteers, Sevoflurane (S) | Thirty-six healthy volunteers received four sessions of anesthesia with different common drug combinations while having SedLine EEG sensors placed on their forehead during these sessions to study the effects of these drugs on the brain. The sessions were: propofol (P), sevoflurane (S), propofol with remifentanil (PR), and sevoflurane with remifentanil (SR). | 0 | 36 | 0 | 36 | 2 | 36 |
| EG002 | Healthy Volunteers, Propofol With Remifentanil (PR) | Thirty-six healthy volunteers received four sessions of anesthesia with different common drug combinations while having SedLine EEG sensors placed on their forehead during these sessions to study the effects of these drugs on the brain. The sessions were: propofol (P), sevoflurane (S), propofol with remifentanil (PR), and sevoflurane with remifentanil (SR). | 0 | 36 | 0 | 36 | 1 | 36 |
| EG003 | Healthy Volunteers, Sevoflurane With Remifentanil (SR) | Thirty-six healthy volunteers received four sessions of anesthesia with different common drug combinations while having SedLine EEG sensors placed on their forehead during these sessions to study the effects of these drugs on the brain. The sessions were: propofol (P), sevoflurane (S), propofol with remifentanil (PR), and sevoflurane with remifentanil (SR). | 0 | 36 | 0 | 36 | 7 | 36 |
| Hypotension | Vascular disorders |
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| Urine tract infection | Renal and urinary disorders |
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| Pain at arterial line site | Injury, poisoning and procedural complications |
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| Temporary numb sensation in hand | General disorders |
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| Short phase of nodale ECG rhythm | Cardiac disorders |
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| Title | Measurements |
|---|---|
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| SR, PSI-1 (C50) |
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| Title | Measurements |
|---|---|
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| PR, PSI-1 (C50) |
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| Theta1, PSI-2 (PR 2ng/mL) |
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| Theta1, PSI-2 (SR 2ng/mL) |
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| Theta1, PSI-1 (P) |
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| Theta1, PSI-1 (S) |
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| Theta1, PSI-1 (PR 2ng/mL) |
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| Theta1, PSI-1 (SR 2ng/mL) |
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| Theta2, PSI-2 (P) |
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| Theta2, PSI-2 (S) |
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| Theta2, PSI-2 (PR 4ng/mL) |
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| Theta2, PSI-2 (SR 4ng/mL) |
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| Theta2, PSI-1 (P) |
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| Theta2, PSI-1 (S) |
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| Theta2, PSI-1 (PR 4ng/mL) |
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| Theta2, PSI-1 (SR 4ng/mL) |
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