Study of Anaesthesia Costs and Recovery Profiles

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Recovery Profiles and Costs in Sevoflurane and Propofol Based Anaesthesia

Conditions
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Anaesthesia

Intervention / Treatment
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* Drug: Sevoflurane group A
* Drug: Sevoflurane group B
* Drug: Propofol group C
* Drug: Propofol group D


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sevoflurane group A<br>Anaesthesia was maintained with sevoflurane (1-2% end-tidal concentration, MAC 1.0-1.5) in 50% air and 50% oxygen mixture. | Drug: Sevoflurane group A<br>* 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.<br>* Other names: Sevorane anaesthesia;|
| Other: Sevoflurane group B<br>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. | Drug: Sevoflurane group B<br>* 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.<br>* Other names: Sevorane anaesthesia with BIS and TOF monitoring;|
| Other: Propofol group C<br>During anaesthesia TIVA was applied with a protocol (6 to 8 mg/kg/h propofol). | Drug: Propofol group C<br>* In this group anaesthesia was maintained with propofol. Propofol was administered according to protocol. Propofol dosing was adjusted for the same MAP range.<br>* Other names: Propofol anaesthesia;|
| Other: Propofol group D<br>Propofol dosing was set to maintain target BIS levels of 40 to 60 and MAP for controlled hypotension within 60-85 mmHg. | Drug: Propofol group D<br>* 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.<br>* Other names: Propofol anaesthesia with BIS and TOF monitoring;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anaesthesia, costs, recovery profiles