Study of Anaesthesia Costs and Recovery Profiles

Not Applicable

Completed

• Conditions: Anaesthesia
• Interventions: Drug: Sevoflurane group A; Drug: Propofol group C; Drug: Propofol group D; Drug: Sevoflurane group B

• Registration Number: NCT02920749
• Lead Sponsor: University of Pecs

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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2016-09-25
• Study First Submitted QC: 2016-09-29
• Study First Posted: 2016-09-30
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Results First Submitted: 2016-10-11
• Results First Submitted QC: 2016-10-12
• Results First Posted: 2016-12-06
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-04
• Last Update Posted: 2018-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sevoflurane group A	Sevoflurane group A	Anaesthesia was maintained with sevoflurane (1-2% end-tidal concentration, MAC 1.0-1.5) in 50% air and 50% oxygen mixture.
Propofol group C	Propofol group C	During anaesthesia TIVA was applied with a protocol (6 to 8 mg/kg/h propofol).
Propofol group D	Propofol group D	Propofol dosing was set to maintain target BIS levels of 40 to 60 and MAP for controlled hypotension within 60-85 mmHg.
Sevoflurane group B	Sevoflurane group B	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Costs of Anaesthesia	1 hour	total cost of drugs (midazolam, propofol 1%, sevoflurane, atracurium, diclofenac, nalbuphin and antidotes) and disposable cost in euros

Trial Locations

Locations (1)

Tímea Bocskai; 🇭🇺 Pecs, Ifjusag Street 13., Hungary