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The purpose of this study is to compare the perioperative hemodynamic parameters, recovery profiles and cost containment of sevoflurane and propofol based general anesthesia for otorhinolaryngeal surgery.
Sevoflurane and propofol are two basic drugs in the maintenance of anaesthesia. In this study we compared the perioperative hemodynamic parameters, recovery profiles and cost containment of sevoflurane and propofol based general anaesthesia for otorhinolaryngeal surgery. Patients were equally divided into four anaesthetic subgroups. In groups A and C anaesthesia was based on sevoflurane or propofol, respectively, without bispectral index (BIS) and train-of-for monitor (TOF) monitoring. In groups B and D anaesthesia was based on sevoflurane or propofol, respectively, with BIS and TOF monitoring. Drug consumption, recovery profiles and anaesthesia costs were analysed.
ECG, main arterial pressure (MAP), heart rate, oxygen saturation of peripheral haemoglobin (SpO2), pressure of end-tidal carbon dioxide was monitored continuously and registered at 5 min intervals during anaesthesia. Each group received propofol for anaesthesia induction. In group A and B anaesthesia was maintained with sevoflurane, in groups C and D with propofol. In groups B and D the depth of anaesthesia (BIS® Quatro Brain Monitoring Sensor, Covidien) and the neuromuscular blocking status (Infinity®, Trident® NMT SmartPod®, Dräger Medical) were monitored too. BIS and TOF values were recorded at 5 min intervals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sevoflurane group A | Other | Anaesthesia was maintained with sevoflurane (1-2% end-tidal concentration, MAC 1.0-1.5) in 50% air and 50% oxygen mixture. |
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| Sevoflurane group B | Other | Anaesthesia was maintained with sevoflurane (1-2% end-tidal concentration, MAC 1.0-1.5) in 50% air and 50% oxygen mixture. Sevoflurane dosing was set to maintain target BIS levels of 40 to 60 and MAP for controlled hypotension within 60-85 mmHg. |
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| Propofol group C | Other | During anaesthesia TIVA was applied with a protocol (6 to 8 mg/kg/h propofol). |
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| Propofol group D | Other | Propofol dosing was set to maintain target BIS levels of 40 to 60 and MAP for controlled hypotension within 60-85 mmHg. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sevoflurane group A | Drug | In this group anaesthesia was maintained with sevoflurane. Initial and maintenance fresh gas flow was 4 and 1 l/min, respectively. Sevoflurane dosing was adjusted for the same MAP range. |
| Measure | Description | Time Frame |
|---|---|---|
| Drug Consumption | drugs of sevoflurane or total intravenous anaesthesia without or with BIS and TOF monitoring : fentanyl, sevoflurane, propofol 1%, atracurium in milligrams | at induction one dose and during anaesthesia mg/1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Costs of Anaesthesia | total cost of drugs (midazolam, propofol 1%, sevoflurane, atracurium, diclofenac, nalbuphin and antidotes) and disposable cost in euros | 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Csaba Loibl, MD | Department of Anesthesiology and Intensive Therapy, University of Pecs, Hungary | Study Chair |
| Zoltan Vamos, MD, PhD | Department of Anesthesiology and Intensive Therapy, University of Pecs, Hungary | Study Chair |
| Gabor Woth, MD, PhD | Department of Anesthesiology and Intensive Therapy, University of Pecs, Hungary | Study Chair |
| Lajos Bogar, MD, PhD, DSc | Department of Anesthesiology and Intensive Therapy, University of Pecs, Hungary | Study Director |
| Laszlo Lujber, MD, PhD | Department of Otorhinolaryngology, University of Pecs, Hungary | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tímea Bocskai | Pécs | Ifjusag Street 13. | 7624 | Hungary |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30055562 | Derived | Bocskai T, Loibl C, Vamos Z, Woth G, Molnar T, Bogar L, Lujber L. Cost-effectiveness of anesthesia maintained with sevoflurane or propofol with and without additional monitoring: a prospective, randomized controlled trial. BMC Anesthesiol. 2018 Jul 28;18(1):100. doi: 10.1186/s12871-018-0563-z. |
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Data of primary outcome measures will be made available within one month of study completion
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We studied patients with ASA physical status I or II, their age between was between 18 and 65 years. Individuals with a history of pulmonary, psychiatric, cerebrovascular or congenital neuromuscular disease were excluded from the study. Patients were blocked randomised to one of four anaesthetic treatment groups with closed envelops.
In this study we compared the perioperative hemodynamic parameters, recovery profiles and cost containment of sevoflurane and propofol based general anaesthesia with controlled hypotension for otorhinolaryngeal surgery.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A | Anaesthesia was maintained with sevoflurane. Initial and maintenance fresh gas flow was 4 and 1 l/min, respectively. Sevoflurane and fentanyl dosing was adjusted for the same MAP range for controlled hypotension within 60-85 mmHg. Atracurium was administered at regular intervals. |
| FG001 | Group B | In this group anaesthesia was maintained with sevoflurane. Initial and maintenance fresh gas flow was 4 and 1 l/min, respectively. The depth of anaesthesia (BIS® Quatro Brain Monitoring Sensor, Covidien) and the neuromuscular blocking status (Infinity®, Trident® NMT SmartPod®, Dräger Medical) was monitored too. Sevoflurane and fentanyl dosing was set to maintain target BIS levels of 40 to 60 and MAP for controlled hypotension within 60-85 mmHg. Neuromuscular blocking was maintained with a TOF monitor at the level of one or no response. |
| FG002 | Group C | Anaesthesia was maintained with propofol. Propofol was administered according to protocol. Propofol and fentanyl dosing was adjusted for the same MAP range. Atracurium was administered at regular intervals. |
| FG003 | Group D | In this group anaesthesia was maintained with propofol. The depth of anaesthesia (BIS® Quatro Brain Monitoring Sensor, Covidien) and the neuromuscular blocking status (Infinity®, Trident® NMT SmartPod®, Dräger Medical) was monitored too. Propofol and fentanyl dosing was set to maintain target BIS levels of 40 to 60 and MAP for controlled hypotension within 60-85 mmHg. Neuromuscular blocking was maintained with a TOF monitor at the level of one or no response. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A | General anaesthesia was maintained with sevoflurane. |
| BG001 | Group B | Anaesthesia was maintained with sevoflurane and the depth of anaesthesia (BIS® Quatro Brain Monitoring Sensor, Covidien) and the neuromuscular blocking status (Infinity®, Trident® NMT SmartPod®, Dräger Medical) was monitored too. |
| 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, Categorical | Count of Participants |
| 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 | Drug Consumption | drugs of sevoflurane or total intravenous anaesthesia without or with BIS and TOF monitoring : fentanyl, sevoflurane, propofol 1%, atracurium in milligrams | Posted | Mean | Standard Deviation | mg | at induction one dose and during anaesthesia mg/1 hour |
|
2 years
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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 A | Anaesthesia was maintained with sevoflurane (1-2% end-tidal concentration, MAC 1.0-1.5) in 50% air and 50% oxygen mixture. Fentanyl consumption was studied during anaesthesia. It was registered in milligram. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| vomiting | Gastrointestinal disorders | Systematic Assessment |
This study is restricted to anaesthesia of otorhinolaryngological surgery with controlled hypotension. Therefore, we cannot draw any conclusions related to other surgeries.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Timea Bocskai | Department of Anaesthesiology and Intensive Therapy, University of Pecs | 36 72 507374 | bocskai.timea@pte.hu |
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| Sevoflurane group B | Drug | In this group anaesthesia was maintained with sevoflurane. Initial and maintenance fresh gas flow was 4 and 1 l/min, respectively. Sevoflurane dosing was set to maintain target BIS levels of 40 to 60 and MAP for controlled hypotension within 60-85 mmHg. |
|
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| Propofol group C | Drug | In this group anaesthesia was maintained with propofol. Propofol was administered according to protocol. Propofol dosing was adjusted for the same MAP range. |
|
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| Propofol group D | Drug | In this group anaesthesia was maintained with propofol. Propofol dosing was set to maintain target BIS levels of 40 to 60 and MAP for controlled hypotension within 60-85 mmHg. |
|
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| BG002 | Group C | General anaesthesia was maintained with propofol. |
| BG003 | Group D | Anaesthesia was maintained with propofol and the depth of anaesthesia (BIS® Quatro Brain Monitoring Sensor, Covidien) and the neuromuscular blocking status (Infinity®, Trident® NMT SmartPod®, Dräger Medical) was monitored too. |
| BG004 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Fentanyl consumption was studied during total intravenous anaesthesia. It was registered in milligram. |
| OG003 | Group D | Fentanyl consumption was studied during total intravenous anaesthesia with BIS and TOF monitoring. It was registered in milligram. |
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| Secondary | Costs of Anaesthesia | total cost of drugs (midazolam, propofol 1%, sevoflurane, atracurium, diclofenac, nalbuphin and antidotes) and disposable cost in euros | Posted | Mean | Standard Deviation | euros | 1 hour | total cost of anaesthesia | total cost of anaesthesia |
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| 0 |
| 30 |
| 14 |
| 30 |
| EG001 | Group B | Anaesthesia was maintained with sevoflurane (1-2% end-tidal concentration, MAC 1.0-1.5) in 50% air and 50% oxygen mixture. Fentanyl consumption was studied during anaesthesia. It was registered in milligram. . | 0 | 30 | 15 | 30 |
| EG002 | Group C | During anaesthesia TIVA was applied with a protocol (6 to 8 mg/kg/h propofol). Fentanyl consumption was studied during anaesthesia. It was registered in milligram. | 0 | 30 | 4 | 30 |
| EG003 | Group D | During anaesthesia TIVA was applied with a protocol (6 to 8 mg/kg/h propofol). Fentanyl consumption was studied during anaesthesia. It was registered in milligram. | 0 | 30 | 8 | 30 |
| other minor complications of anaesthesia | Cardiac disorders | Systematic Assessment |
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| total cost of anaesthesia |
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| total disposable cost |
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| total cost of anaesthesia |
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