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Study of Anaesthesia Costs and Recovery Profiles (SACRP)

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ClinicalTrials.gov Identifier: NCT02920749
Recruitment Status : Completed
First Posted : September 30, 2016
Results First Posted : December 6, 2016
Last Update Posted : February 6, 2018
Sponsor:
Information provided by (Responsible Party):
Timea Bocskai, University of Pecs

Study Description
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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.

Condition or disease Intervention/treatment Phase
Anaesthesia Drug: Sevoflurane group A Drug: Sevoflurane group B Drug: Propofol group C Drug: Propofol group D Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Recovery Profiles and Costs in Sevoflurane and Propofol Based Anaesthesia
Study Start Date : September 2014
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 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.
Other Name: Sevorane anaesthesia
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.
 Drug: 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.
Other Name: Sevorane anaesthesia with BIS and TOF monitoring
Propofol group C
During anaesthesia TIVA was applied with a protocol (6 to 8 mg/kg/h propofol).
 Drug: 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.
Other Name: Propofol anaesthesia
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.
 Drug: 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.
Other Name: Propofol anaesthesia with BIS and TOF monitoring


Outcome Measures
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Primary Outcome Measures :
  1. Drug Consumption [ Time Frame: 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 :
  1. Costs of Anaesthesia [ Time Frame: 1 hour ]
    total cost of drugs (midazolam, propofol 1%, sevoflurane, atracurium, diclofenac, nalbuphin and antidotes) and disposable cost in euros


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02920749


Locations
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Hungary
Tímea Bocskai
Pecs, Ifjusag Street 13., Hungary, 7624
Sponsors and Collaborators
University of Pecs
Investigators
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Study Chair: Csaba Loibl, MD Department of Anesthesiology and Intensive Therapy, University of Pecs, Hungary
Study Chair: Zoltan Vamos, MD, PhD Department of Anesthesiology and Intensive Therapy, University of Pecs, Hungary
Study Chair: Gabor Woth, MD, PhD Department of Anesthesiology and Intensive Therapy, University of Pecs, Hungary
Study Director: Lajos Bogar, MD, PhD, DSc Department of Anesthesiology and Intensive Therapy, University of Pecs, Hungary
Study Director: Laszlo Lujber, MD, PhD Department of Otorhinolaryngology, University of Pecs, Hungary
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Timea Bocskai, Assistant Professor, University of Pecs
ClinicalTrials.gov Identifier: NCT02920749    
Other Study ID Numbers: 316-2336/KK15
First Posted: September 30, 2016    Key Record Dates
Results First Posted: December 6, 2016
Last Update Posted: February 6, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data of primary outcome measures will be made available within one month of study completion
Keywords provided by Timea Bocskai, University of Pecs:
anaesthesia
costs
recovery profiles
Additional relevant MeSH terms:
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Anesthetics
Propofol
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
 Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Platelet Aggregation Inhibitors
Anesthetics, Inhalation