Anaesthesia
Conditions
Keywords
anaesthesia, costs, recovery profiles
Brief summary
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.
Detailed description
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.
Interventions
DRUGSevoflurane group A
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.
DRUGSevoflurane group B
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.
DRUGPropofol group C
In this group anaesthesia was maintained with propofol. Propofol was administered according to protocol. Propofol dosing was adjusted for the same MAP range.
DRUGPropofol group D
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.
Sponsors
University of Pecs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* ASA physical status grade I or II who were scheduled for elective otorhinolaryngological surgery.
Exclusion criteria
* Individuals with a history of bronchial asthma, chronic obstructive pulmonary disease, epilepsy, psychiatric illness, cerebrovascular or congenital neuromuscular disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Drug Consumption | at induction one dose and during anaesthesia mg/1 hour | drugs of sevoflurane or total intravenous anaesthesia without or with BIS and TOF monitoring : fentanyl, sevoflurane, propofol 1%, atracurium in milligrams |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Costs of Anaesthesia | 1 hour | total cost of drugs (midazolam, propofol 1%, sevoflurane, atracurium, diclofenac, nalbuphin and antidotes) and disposable cost in euros |
Countries
Hungary
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Group A General anaesthesia was maintained with sevoflurane. | 30 |
| 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. | 30 |
| Group C General anaesthesia was maintained with propofol. | 30 |
| 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. | 30 |
| Total | 120 |
Baseline characteristics
| Characteristic | Total | Group A | Group B | Group C | Group D |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 120 Participants | 30 Participants | 30 Participants | 30 Participants | 30 Participants |
| Region of Enrollment Hungary | 120 participants | 30 participants | 30 participants | 30 participants | 30 participants |
| Sex: Female, Male Female | 65 Participants | 14 Participants | 16 Participants | 19 Participants | 16 Participants |
| Sex: Female, Male Male | 55 Participants | 16 Participants | 14 Participants | 11 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 14 / 30 | 15 / 30 | 4 / 30 | 8 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 |
Outcome results
Primary
Drug Consumption
drugs of sevoflurane or total intravenous anaesthesia without or with BIS and TOF monitoring : fentanyl, sevoflurane, propofol 1%, atracurium in milligrams
Time frame: at induction one dose and during anaesthesia mg/1 hour
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Drug Consumption | fentanyl at induction | 0.0983 mg | Standard Deviation 0.0091 |
| Group A | Drug Consumption | propofol during anesthesia | 0 mg | Standard Deviation 0 |
| Group A | Drug Consumption | sevoflurane during anesthesia | 11400 mg | Standard Deviation 2800 |
| Group A | Drug Consumption | propofol at induction | 196.3 mg | Standard Deviation 46.9 |
| Group A | Drug Consumption | atracurium during anaesthesia | 8.3 mg | Standard Deviation 3.7 |
| Group A | Drug Consumption | atracurium at induction | 38.3 mg | Standard Deviation 4.2 |
| Group A | Drug Consumption | fentanyl during anaesthesia | 0.0546 mg | Standard Deviation 0.0269 |
| Group B | Drug Consumption | propofol during anesthesia | 0 mg | Standard Deviation 0 |
| Group B | Drug Consumption | fentanyl during anaesthesia | 0.0598 mg | Standard Deviation 0.0389 |
| Group B | Drug Consumption | atracurium at induction | 37.3 mg | Standard Deviation 6.7 |
| Group B | Drug Consumption | sevoflurane during anesthesia | 14800 mg | Standard Deviation 12400 |
| Group B | Drug Consumption | atracurium during anaesthesia | 7.4 mg | Standard Deviation 4.7 |
| Group B | Drug Consumption | propofol at induction | 166.4 mg | Standard Deviation 35.2 |
| Group B | Drug Consumption | fentanyl at induction | 0.1033 mg | Standard Deviation 0.0183 |
| Group C | Drug Consumption | fentanyl during anaesthesia | 0.0898 mg | — |
| Group C | Drug Consumption | fentanyl at induction | 0.0991 mg | Standard Deviation 0.0046 |
| Group C | Drug Consumption | propofol at induction | 194.3 mg | Standard Deviation 18.9 |
| Group C | Drug Consumption | atracurium at induction | 36.0 mg | Standard Deviation 5.7 |
| Group C | Drug Consumption | sevoflurane during anesthesia | 0 mg | Standard Deviation 0 |
| Group C | Drug Consumption | propofol during anesthesia | 1185.5 mg | Standard Deviation 320.9 |
| Group C | Drug Consumption | atracurium during anaesthesia | 8.5 mg | Standard Deviation 4.7 |
| Group D | Drug Consumption | atracurium at induction | 37.7 mg | Standard Deviation 7 |
| Group D | Drug Consumption | atracurium during anaesthesia | 8.9 mg | Standard Deviation 6.1 |
| Group D | Drug Consumption | propofol during anesthesia | 1082.1 mg | Standard Deviation 297.9 |
| Group D | Drug Consumption | propofol at induction | 147.3 mg | Standard Deviation 30.2 |
| Group D | Drug Consumption | fentanyl at induction | 0.0992 mg | Standard Deviation 0.0103 |
| Group D | Drug Consumption | sevoflurane during anesthesia | 0 mg | Standard Deviation 0 |
| Group D | Drug Consumption | fentanyl during anaesthesia | 0.0947 mg | Standard Deviation 0.034 |
Comparison: Statistical analysis was carried out with SPSS version 21 for Windows (IBM Corporation) software. All data are expressed as means ± SD. Mann-Whitney test was performed to assess the differences between patient subgroups.p-value: <0.05ANOVA
Secondary
Costs of Anaesthesia
total cost of drugs (midazolam, propofol 1%, sevoflurane, atracurium, diclofenac, nalbuphin and antidotes) and disposable cost in euros
Time frame: 1 hour
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Costs of Anaesthesia | total drug cost | 8.84 euros | Standard Deviation 4.11 |
| Group A | Costs of Anaesthesia | total cost of anaesthesia | 12.15 euros | Standard Deviation 5.32 |
| Group A | Costs of Anaesthesia | total disposable cost | 6.49 euros | Standard Deviation 0.11 |
| Group B | Costs of Anaesthesia | total drug cost | 7.86 euros | Standard Deviation 3.54 |
| Group B | Costs of Anaesthesia | total cost of anaesthesia | 19.95 euros | Standard Deviation 8.53 |
| Group B | Costs of Anaesthesia | total disposable cost | 23.25 euros | Standard Deviation 0.12 |
| Group C | Costs of Anaesthesia | total disposable cost | 8.09 euros | Standard Deviation 0.07 |
| Group C | Costs of Anaesthesia | total drug cost | 8.33 euros | Standard Deviation 3.02 |
| Group C | Costs of Anaesthesia | total cost of anaesthesia | 13.23 euros | Standard Deviation 4.23 |
| Group D | Costs of Anaesthesia | total drug cost | 7.52 euros | Standard Deviation 2.49 |
| Group D | Costs of Anaesthesia | total cost of anaesthesia | 22.11 euros | Standard Deviation 8.08 |
| Group D | Costs of Anaesthesia | total disposable cost | 24.76 euros | Standard Deviation 0.19 |
Comparison: Statistical analysis was carried out with SPSS version 21 for Windows (IBM Corporation) software. All data are expressed as means ± SD. Mann-Whitney test was performed to assess the differences between patient subgroups.p-value: <0.05ANOVA