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The main purpose of this research is to develop a population pharmacokinetic and pharmacodynamic model of Propofol when used for induction and maintenance of anaesthesia, using BIS as a pharmacodynamic endpoint.
A covariate analysis will be performed in order to account for variability in pharmacokinetic and pharmacodynamic parameters. The influence of age and obesity on propofol pharmacokinetic parameters will be particularly addressed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (≥18 years, BMI<35kg/m2) | Patients with 18 or more years presenting for inpatient nose and ear surgery. |
| |
| Group 2 (≥18 years, ≥35kg/m2) | Patients with 18 or more years presenting for inpatient bariatric surgery. |
| |
| Group 3 (≥65 years) | Patients with 65 or more years presenting for orthopaedic surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol | Drug | The whole anaesthetic procedure is standard except for additional body composition assessment with Body Composition Monitor - BCM (Fresenius Medical Care, Germany) and arterial blood samples collection. In all included patients, propofol will be started at 2000mg/h until LOC, defined by "loss of eye-lash reflex" and "loss of response to name calling". During surgery propofol infusion will be guided by targeted BIS values between 40 and 60. Arterial blood samples will be obtained immediately after LOC and after every 20-30 minutes during propofol infusion. After stopping propofol infusion, arterial blood samples will be acquired every 10 minutes until recovery of consciousness. The maximum blood sample per patient will be 20 mL. |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Propofol Concentration (mcg/mL) | Arterial blood samples were obtained after LOC and every 20-30 minutes during propofol infusion. After stopping propofol infusion, arterial blood samples were obtained immediately after recovery of consciousness. At the end of the surgery arterial blood samples were centrifuged at 2862xg for 5 minutes and they were preserved at -80ºC until analysis. The quantification of propofol in serum was performed using gas chromatography/ion trap-mass spectrometry (GC/IT-MS) | up to 2 hours |
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Inclusion Criteria:
Exclusion Criteria:
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Inpatient care at Centro Hospitalar do Porto
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Hospitalar do Porto | Porto | 4099-001 | Portugal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31604419 | Derived | Araujo AM, Machado HS, Falcao AC, Soares-da-Silva P. Bioelectrical impedance analysis of body composition for the anesthetic induction dose of propofol in older patients. BMC Anesthesiol. 2019 Oct 11;19(1):180. doi: 10.1186/s12871-019-0856-x. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 (≥18 Years, BMI<35kg/m2) | Patients with 18 or more years presenting for inpatient nose and ear surgery. |
| FG001 | Group 2 (≥18 Years, BMI≥35kg/m2) | Patients with 18 or more years presenting for inpatient bariatric surgery. |
| FG002 | Group 3 (≥65 Years) | Patients with 65 or more years presenting for urgent orthopaedic surgery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 (≥18 Years, BMI<35kg/m2) | Patients with 18 or more years presenting for inpatient nose and ear surgery. |
| BG001 | Group 2 (≥18 Years, BMI≥35kg/m2) | Patients with 18 or more years presenting for inpatient bariatric surgery. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Plasma Propofol Concentration (mcg/mL) | Arterial blood samples were obtained after LOC and every 20-30 minutes during propofol infusion. After stopping propofol infusion, arterial blood samples were obtained immediately after recovery of consciousness. At the end of the surgery arterial blood samples were centrifuged at 2862xg for 5 minutes and they were preserved at -80ºC until analysis. The quantification of propofol in serum was performed using gas chromatography/ion trap-mass spectrometry (GC/IT-MS) | Posted | Mean | Standard Deviation | mcg/mL | up to 2 hours |
|
Perioperative period
The proposed study is a cross sectional analytical study.The whole anaesthetic procedure was standard except for additional body composition assessment with Body Composition Monitor - BCM (Fresenius Medical Care, Germany) and arterial blood samples collection.
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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 | Group 1 (≥18 Years, BMI<35kg/m2) | Patients with 18 or more years presenting for inpatient nose and ear surgery. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mean arterial pressure (MAP) variation >40% after induction of general anesthesia | Cardiac disorders | Systematic Assessment | Patients in whom a variation higher than 40% was registered after induction of general anesthesia were treated with ephedrine and fluid boluses to return MAP to baseline levels. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ana Maria Araujo | Centro Hospitalar do Porto | 22 2077549 | 1280 | amfariaaraujo@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 8, 2016 | Sep 21, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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Arterial blood samples will be collected in serum tubes and centrifuged at 2000 rpm for 15 minutes in order to obtain serum. Serum will be preserved at -80ºC until analysis.
|
| BG002 | Group 3 (≥65 Years) | Patients with 65 or more years presenting for urgent orthopaedic surgery. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Patients with 18 or more years presenting for inpatient bariatric surgery.
| OG002 | Group 3 (≥65 Years) | Patients with 65 or more years presenting for urgent orthopaedic surgery. |
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Group 2 (≥18 Years, BMI≥35kg/m2) | Patients with 18 or more years presenting for inpatient bariatric surgery. | 0 | 20 | 0 | 20 | 1 | 20 |
| EG002 | Group 3 (≥65 Years) | Patients with 65 or more years presenting for urgent orthopaedic surgery. | 0 | 20 | 0 | 20 | 6 | 20 |
|
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |