Overview

This trial is active, not recruiting.

Condition anesthesia
Treatments sevoflurane, propofol
Sponsor University of Pecs
Start date September 2014
End date October 2016
Trial size 120 participants
Trial identifier NCT02920749, 316-2336/KK15

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Other)
Anaesthesia was maintained with sevoflurane (1-2% end-tidal concentration, MAC 1.0-1.5) in 50% air and 50% oxygen mixture.
sevoflurane Sevorane
In groups A and B 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 in group A. In group B sevoflurane and propofol dosing was set to maintain target BIS levels of 40 to 60 and MAP for controlled hypotension within 60-85 mmHg.
(Other)
During anesthesia TIVA was applied with a protocol (6 to 8 mg/kg/h propofol).
propofol Propofol 1% MCT/LCT Fresenius
In groups C and D anaesthesia was maintained with propofol. In group C propofol was administered according to protocol. Propofol dosing was adjusted for the same MAP range in group C. In group D propofol dosing was set to maintain target BIS levels of 40 to 60 and MAP for controlled hypotension within 60-85 mmHg.

Primary Outcomes

Measure
drug consumption of anesthesia
time frame: two years

Secondary Outcomes

Measure
costs of anesthesia
time frame: two years

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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.

Additional Information

Official title Recovery Profiles and Costs in Sevoflurane and Propofol Based Anesthesia
Description Sevoflurane and propofol are two basic drugs in the maintenance of anesthesia. 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by University of Pecs.