Study of Anaesthesia Costs and Recovery Profiles

Anaesthesia Clinical Trial

— SACRP  

Official title:

Recovery Profiles and Costs in Sevoflurane and Propofol Based Anaesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02920749
• Other study ID #: 316-2336/KK15
• Status: Completed
• Phase: N/A
• First received: September 25, 2016
• Last updated: February 4, 2018
• Start date: September 2014
• Est. completion date: October 2016

Study information

• Verified date: February 2018
• Source: University of Pecs
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anaesthesia

Intervention

Drug:
• Sevoflurane 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.
• Sevoflurane 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.
• Propofol 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.
• Propofol 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.

Locations

Country	Name	City	State
Hungary	Tímea Bocskai	Pecs	Ifjusag Street 13.

Sponsors (1)

Lead Sponsor	Collaborator
University of Pecs

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Costs of Anaesthesia	total cost of drugs (midazolam, propofol 1%, sevoflurane, atracurium, diclofenac, nalbuphin and antidotes) and disposable cost in euros	1 hour