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| ID | Type | Description | Link |
|---|---|---|---|
| s100b | Other Identifier | s100b |
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The aim of this study is to distinguish possible differences in frequency of delirium after Volatile Induction and Maintenance of Anesthesia and Total Intravenous Anesthesia in case of undeliberate cerebral desaturation during non-cardiac surgery.
The aim of the present study is to investigate whether in non-cardiac surgery the frequency of POD after intraoperative undeliberate cerebral saturation could be modulated by the choice of the anesthetic strategy (Volatile Induction and Maintenance of Anesthesia [VIMA] and Total Intravenous Anesthesia [TIVA]). Based on our previous data we hypothesized that incidence of POD would be lower with VIMA compared to TIVA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sevoflurane | Active Comparator | Sevoflurane Based Volatile Induction and Maintenance of Anaesthesia |
|
| Propofol | Active Comparator | Propofol Based Total Intravenous Anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sevoflurane | Drug | Induction of anesthesia: fentanyl 2 µg kg-1 and a bolus inhalation of 8% sevoflurane in an 8 L.min-1 fresh gas flow. Anesthesia maintenance: 1 minimal alveolar concentration (MAC) sevoflurane at a low fresh gas flow of 0.6-0.8 L min-1 in a 60% air-oxygen mixture supplemented with boluses of fentanyl. |
| Measure | Description | Time Frame |
|---|---|---|
| Regional Cerebral Oxygenation (rSO2) | Continued the entire surgery | |
| Peripheral tissue oxygen saturation (SpO2) | Continued the entire surgery | |
| Non-invasive blood pressure (NIBP) | Continued the entire surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Incidences of postoperative delirium (POD) | Applying the Confusion Assessment Method for the ICU (CAM-ICU) | Baseline, 24h and 48h after surgery |
| Plasma concentration of S100b protein |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Valery V. Likhvantsev, MD, Prof. | Contact | lik0704@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Valery V. Likhvantsev, MD, Prof. | Negovsky Reanimatology Research Institute, Moscow, Russia | Study Chair |
| Oleg A. Grebenchikov, MD, PhD | Negovsky Reanimatology Research Institute, Moscow, Russia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical center of the Main Administration for Service to the Diplomatic Corps | Recruiting | Moscow | Russia |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 25, 2020 | |
| Reset | Mar 17, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 25, 2020 | Mar 17, 2020 |
| ID | Term |
|---|---|
| D002534 | Hypoxia, Brain |
| D000071257 | Emergence Delirium |
| D003693 | Delirium |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000860 | Hypoxia |
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| ID | Term |
|---|---|
| D000077149 | Sevoflurane |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D006845 | Hydrocarbons, Fluorinated |
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|
|
| Propofol | Drug | Induction of anesthesia: propofol 2 mg kg-1 and fentanyl 4 µg kg-1. Maintenance of anesthesia: infusion of propofol 8 mg kg-1 h-1 and boluses of fentanyl 3 µg kg-1. |
|
|
S100b protein is the neuronal injury marker
| Baseline, 24h and 48h after surgery |
| Yuri V. Iljin | Negovsky Reanimatology Research Institute, Moscow, Russia | Principal Investigator |
| Alexander V. Mironenko, MD, PhD | Negovsky Reanimatology Research Institute, Moscow, Russia | Principal Investigator |
| Yuri V. Skripkin | Negovsky Reanimatology Research Institute, Moscow, Russia | Principal Investigator |
| Dmitriy B. Selivanov, MD, PhD | Hospital Maria Vittoria, Turin, Italy | Principal Investigator |
| D012818 |
| Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006846 |
| Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |