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SACRP: Study of Anaesthesia Costs and Recovery Profiles

Sponsor
University of Pecs (Other)
Overall Status
Completed
CT.gov ID
NCT02920749
Collaborator
(none)
120
Enrollment
1
Location
4
Arms
25
Duration (Months)
4.8
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: Sevoflurane group A
  • Drug: Sevoflurane group B
  • Drug: Propofol group C
  • Drug: Propofol group D
 N/A

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

Study Type:
Interventional
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 :
Sep 1, 2014
Actual Primary Completion Date :
Oct 1, 2016
Actual Study Completion Date :
Oct 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Other: 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 Names:
  • Sevorane anaesthesia

    		•
    Other: 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 Names:
  • Sevorane anaesthesia with BIS and TOF monitoring

    		•
    Other: 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 Names:
  • Propofol anaesthesia

    		•
    Other: 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 Names:
  • Propofol anaesthesia with BIS and TOF monitoring

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Costs of Anaesthesia [1 hour]

      total cost of drugs (midazolam, propofol 1%, sevoflurane, atracurium, diclofenac, nalbuphin and antidotes) and disposable cost in euros

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 Tímea Bocskai Pecs Ifjusag Street 13. Hungary 7624

    Sponsors and Collaborators

    • University of Pecs

    Investigators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Timea Bocskai, Assistant Professor, University of Pecs
    ClinicalTrials.gov Identifier:
    NCT02920749
    Other Study ID Numbers:
    • 316-2336/KK15
    First Posted:
    Sep 30, 2016
    Last Update Posted:
    Feb 6, 2018
    Last Verified:
    Feb 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Timea Bocskai, Assistant Professor, University of Pecs
    anaesthesia
    costs
    recovery profiles
    Additional relevant MeSH terms:
    Anesthetics
    Propofol
    Sevoflurane

    Study Results

    Participant Flow

    Recruitment Details In this study we compared the perioperative hemodynamic parameters, recovery profiles and cost containment of sevoflurane and propofol based general anaesthesia with controlled hypotension for otorhinolaryngeal surgery.
    Pre-assignment Detail We studied patients with ASA physical status I or II, their age between was between 18 and 65 years. Individuals with a history of pulmonary, psychiatric, cerebrovascular or congenital neuromuscular disease were excluded from the study. Patients were blocked randomised to one of four anaesthetic treatment groups with closed envelops.
    Arm/Group Title Group A Group B Group C Group D
    Arm/Group Description Anaesthesia was maintained with sevoflurane. Initial and maintenance fresh gas flow was 4 and 1 l/min, respectively. Sevoflurane and fentanyl dosing was adjusted for the same MAP range for controlled hypotension within 60-85 mmHg. Atracurium was administered at regular intervals. In this group anaesthesia was maintained with sevoflurane. Initial and maintenance fresh gas flow was 4 and 1 l/min, respectively. The depth of anaesthesia (BIS® Quatro Brain Monitoring Sensor, Covidien) and the neuromuscular blocking status (Infinity®, Trident® NMT SmartPod®, Dräger Medical) was monitored too. Sevoflurane and fentanyl dosing was set to maintain target BIS levels of 40 to 60 and MAP for controlled hypotension within 60-85 mmHg. Neuromuscular blocking was maintained with a TOF monitor at the level of one or no response. Anaesthesia was maintained with propofol. Propofol was administered according to protocol. Propofol and fentanyl dosing was adjusted for the same MAP range. Atracurium was administered at regular intervals. In this group anaesthesia was maintained with propofol. The depth of anaesthesia (BIS® Quatro Brain Monitoring Sensor, Covidien) and the neuromuscular blocking status (Infinity®, Trident® NMT SmartPod®, Dräger Medical) was monitored too. Propofol and fentanyl dosing was set to maintain target BIS levels of 40 to 60 and MAP for controlled hypotension within 60-85 mmHg. Neuromuscular blocking was maintained with a TOF monitor at the level of one or no response.
    Period Title: Overall Study
    STARTED 30 30 30 30
    COMPLETED 30 30 30 30
    NOT COMPLETED 0 0 0 0

    Baseline Characteristics

    Arm/Group Title Group A Group B Group C Group D Total
    Arm/Group Description General anaesthesia was maintained with sevoflurane. Anaesthesia was maintained with sevoflurane and the depth of anaesthesia (BIS® Quatro Brain Monitoring Sensor, Covidien) and the neuromuscular blocking status (Infinity®, Trident® NMT SmartPod®, Dräger Medical) was monitored too. General anaesthesia was maintained with propofol. Anaesthesia was maintained with propofol and the depth of anaesthesia (BIS® Quatro Brain Monitoring Sensor, Covidien) and the neuromuscular blocking status (Infinity®, Trident® NMT SmartPod®, Dräger Medical) was monitored too. Total of all reporting groups
    Overall Participants 30 30 30 30 120
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    30
    100%
    30
    100%
    30
    100%
    30
    100%
    120
    100%
    >=65 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Sex: Female, Male (Count of Participants)
    Female
    14
    46.7%
    16
    53.3%
    19
    63.3%
    16
    53.3%
    65
    54.2%
    Male
    16
    53.3%
    14
    46.7%
    11
    36.7%
    14
    46.7%
    55
    45.8%
    Region of Enrollment (participants) [Number]
    Hungary
    30
    100%
    30
    100%
    30
    100%
    30
    100%
    120
    100%

    Outcome Measures

    1. Primary Outcome
    Title Drug Consumption
    Description drugs of sevoflurane or total intravenous anaesthesia without or with BIS and TOF monitoring : fentanyl, sevoflurane, propofol 1%, atracurium in milligrams
    Time Frame at induction one dose and during anaesthesia mg/1 hour

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Group A Group B Group C Group D
    Arm/Group Description Fentanyl consumption was studied during sevoflurane anaesthesia. It was registered in milligram. Fentanyl consumption was studied during sevoflurane anaesthesia with BIS and TOF monitoring. It was registered in milligram. . Fentanyl consumption was studied during total intravenous anaesthesia. It was registered in milligram. Fentanyl consumption was studied during total intravenous anaesthesia with BIS and TOF monitoring. It was registered in milligram.
    Measure Participants 30 30 30 30
    fentanyl at induction
    0.0983
    (0.0091)
    0.1033
    (0.0183)
    0.0991
    (0.0046)
    0.0992
    (0.0103)
    propofol at induction
    196.3
    (46.9)
    166.4
    (35.2)
    194.3
    (18.9)
    147.3
    (30.2)
    atracurium at induction
    38.3
    (4.2)
    37.3
    (6.7)
    36.0
    (5.7)
    37.7
    (7.0)
    fentanyl during anaesthesia
    0.0546
    (0.0269)
    0.0598
    (0.0389)
    0.0898
    (0,0428)
    0.0947
    (0.0340)
    sevoflurane during anesthesia
    11400
    (2800)
    14800
    (12400)
    0
    (0)
    0
    (0)
    propofol during anesthesia
    0
    (0)
    0
    (0)
    1185.5
    (320.9)
    1082.1
    (297.9)
    atracurium during anaesthesia
    8.3
    (3.7)
    7.4
    (4.7)
    8.5
    (4.7)
    8.9
    (6.1)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group A, Group B, Group C, Group D
    Comments Statistical analysis was carried out with SPSS version 21 for Windows (IBM Corporation) software. All data are expressed as means ± SD. Mann-Whitney test was performed to assess the differences between patient subgroups.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.05
    Comments The P value less than 0.05 was considered to be significant. With type I α = 5% and with type II (power) of 90%, we therefore needed 27 patients/group.
    Method ANOVA
    Comments
    2. Secondary Outcome
    Title Costs of Anaesthesia
    Description total cost of drugs (midazolam, propofol 1%, sevoflurane, atracurium, diclofenac, nalbuphin and antidotes) and disposable cost in euros
    Time Frame 1 hour

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Group A Group B Group C Group D
    Arm/Group Description Drugs at induction were: fentanyl, propofol 1%, atracurium. Anaesthesia was maintained with sevoflurane, fentanyl and atracurium. Cost was calculated in euros/1 hour. Disposable cost was calculated in euros. Drugs at induction were: fentanyl, propofol 1%, atracurium. Anaesthesia was maintained with sevoflurane, fentanyl and atracurium. Cost was calculated in euros/1 hour. Disposable cost was calculated in euros. In this group BIS sensor and TOF monitoring was used. Drugs at induction were: fentanyl, propofol 1%, atracurium. Anaesthesia was maintained with propofol 1%, fentanyl and atracurium. Cost was calculated in euros/1 hour. Disposable cost was calculated in euros. Drugs at induction were: fentanyl, propofol 1%, atracurium. Anaesthesia was maintained with propofol, fentanyl and atracurium. Cost was calculated in euros/1 hour. Disposable cost was calculated in euros. In this group BIS sensor and TOF monitoring was used.
    Measure Participants 30 30 30 30
    Measure total cost of anaesthesia 30 30 30 30
    total drug cost
    8.84
    (4.11)
    7.86
    (3.54)
    8.33
    (3.02)
    7.52
    (2.49)
    total disposable cost
    6.49
    (0.11)
    23.25
    (0.12)
    8.09
    (0.07)
    24.76
    (0.19)
    total cost of anaesthesia
    12.15
    (5.32)
    19.95
    (8.53)
    13.23
    (4.23)
    22.11
    (8.08)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group A, Group B, Group C, Group D
    Comments Statistical analysis was carried out with SPSS version 21 for Windows (IBM Corporation) software. All data are expressed as means ± SD. Mann-Whitney test was performed to assess the differences between patient subgroups.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.05
    Comments The P value less than 0.05 was considered to be significant. With type I α = 5% and with type II (power) of 90%, we therefore needed 27 patients/group.
    Method ANOVA
    Comments

    Adverse Events

    Time Frame 2 years
    Adverse Event Reporting Description
    Arm/Group Title Group A Group B Group C Group D
    Arm/Group Description Anaesthesia was maintained with sevoflurane (1-2% end-tidal concentration, MAC 1.0-1.5) in 50% air and 50% oxygen mixture. Fentanyl consumption was studied during anaesthesia. It was registered in milligram. Anaesthesia was maintained with sevoflurane (1-2% end-tidal concentration, MAC 1.0-1.5) in 50% air and 50% oxygen mixture. Fentanyl consumption was studied during anaesthesia. It was registered in milligram. . During anaesthesia TIVA was applied with a protocol (6 to 8 mg/kg/h propofol). Fentanyl consumption was studied during anaesthesia. It was registered in milligram. During anaesthesia TIVA was applied with a protocol (6 to 8 mg/kg/h propofol). Fentanyl consumption was studied during anaesthesia. It was registered in milligram.
    All Cause Mortality
    Group A Group B Group C Group D
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Group A Group B Group C Group D
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/30 (0%) 0/30 (0%) 0/30 (0%) 0/30 (0%)
    Other (Not Including Serious) Adverse Events
    Group A Group B Group C Group D
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 14/30 (46.7%) 15/30 (50%) 4/30 (13.3%) 8/30 (26.7%)
    Cardiac disorders
    other minor complications of anaesthesia 13/30 (43.3%) 13/30 (43.3%) 3/30 (10%) 7/30 (23.3%)
    Gastrointestinal disorders
    vomiting 1/30 (3.3%) 2/30 (6.7%) 1/30 (3.3%) 1/30 (3.3%)

    Limitations/Caveats

    This study is restricted to anaesthesia of otorhinolaryngological surgery with controlled hypotension. Therefore, we cannot draw any conclusions related to other surgeries.

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. Timea Bocskai
    Organization Department of Anaesthesiology and Intensive Therapy, University of Pecs
    Phone 36 72 507374
    Email bocskai.timea@pte.hu
    Responsible Party:
    Timea Bocskai, Assistant Professor, University of Pecs
    ClinicalTrials.gov Identifier:
    NCT02920749
    Other Study ID Numbers:
    • 316-2336/KK15
    First Posted:
    Sep 30, 2016
    Last Update Posted:
    Feb 6, 2018
    Last Verified:
    Feb 1, 2018