Clinical trial NCT02920749: Study of Anaesthesia Costs and Recovery Profiles
Official title: Recovery Profiles and Costs in Sevoflurane and Propofol Based Anaesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anaesthesia
Keywords: anaesthesia
costs
recovery profiles
Lead sponsor: University of Pecs
Sponsor class: OTHER
First posted: 2016-09-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Drug Consumption
timeFrame: at induction one dose and during anaesthesia mg/1 hour
Secondary outcomes:
measure: Costs of Anaesthesia
timeFrame: 1 hour
Other outcomes:
Locations:
city: Pecs
country: Hungary
facility: Tímea Bocskai
state: Ifjusag Street 13.
Study officials:
affiliation: Department of Anesthesiology and Intensive Therapy, University of Pecs, Hungary
name: Csaba Loibl, MD
role: STUDY_CHAIR
affiliation: Department of Anesthesiology and Intensive Therapy, University of Pecs, Hungary
name: Zoltan Vamos, MD, PhD
role: STUDY_CHAIR
affiliation: Department of Anesthesiology and Intensive Therapy, University of Pecs, Hungary
name: Gabor Woth, MD, PhD
role: STUDY_CHAIR
affiliation: Department of Anesthesiology and Intensive Therapy, University of Pecs, Hungary
name: Lajos Bogar, MD, PhD, DSc
role: STUDY_DIRECTOR
affiliation: Department of Otorhinolaryngology, University of Pecs, Hungary
name: Laszlo Lujber, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.