Clinical Trial Results:
Effect of sevoflurane and propofol on hepato-splanchnic pressure and flow during hepatobiliary surgery.
Summary
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EudraCT number |
2017-000071-90 |
Trial protocol |
BE |
Global end of trial date |
27 Jan 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
01 May 2020
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First version publication date |
01 May 2020
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
AGO/2017/002
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03772106 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Ghent University Hospital
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Sponsor organisation address |
C. Heymanslaan 10, Ghent, Belgium,
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Public contact |
Bimetra Clinics, Ghent University Hospital, Bimetra.Clinics@uzgent.be
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Scientific contact |
Bimetra Clinics, Ghent University Hospital, Bimetra.Clinics@uzgent.be
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
10 Dec 2018
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
27 Jan 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
27 Jan 2018
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Primary objective of the study is to compare the effect of sevoflurane and propofol on hepato-splanchnic pressure and blood flow during hepatobiliary surgery. We hypothesized that sevoflurane induces a dose-dependent reduction of hepato-splanchnic blood flow, while propofol increases hepato-splanchnic blood flow.
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Protection of trial subjects |
Ethics review and approval, informed consent, supportive care and routine monitoring.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
08 Jun 2017
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Belgium: 18
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Worldwide total number of subjects |
18
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EEA total number of subjects |
18
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
8
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From 65 to 84 years |
10
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85 years and over |
0
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Recruitment
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Recruitment details |
35 patients were screened in the period from 08-Jun-2017 till 27-Jan-2017. 29 patients were included, 27 patients were randomised. 18 patients were included and completed the trial. End of trial notification was dated 27-Jan-2018 (last patient last visit) and submitted to EC and CA 16-Nov-2108. | |||||||||
Pre-assignment
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Screening details |
Inclusion Criteria - adult >+ 18 years (Female or Male) - ASA I-II-III -able to comprehend, sign and date the written consent document to participate in the clinical trial - sheduled for hepato-biliary surgery | |||||||||
Period 1
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Period 1 title |
overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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group S | |||||||||
Arm description |
Sevoflurane | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Sevoflurane
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Inhalation solution
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Routes of administration |
Inhalation use
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Dosage and administration details |
Sevoflurane will be titrated according to BIS value between 45-55, which is an adequate depth of anesthesia for surgery
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Arm title
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group P | |||||||||
Arm description |
propofol 1% | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
propofol
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Emulsion for injection/infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Propofol will be titrated according to a Bispectral Index (BIS) value between 45-55, which is an adequate depth of anesthesia for surgery
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Baseline characteristics reporting groups
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Reporting group title |
group S
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Reporting group description |
Sevoflurane | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
group P
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Reporting group description |
propofol 1% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
group S
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Reporting group description |
Sevoflurane | ||
Reporting group title |
group P
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Reporting group description |
propofol 1% |
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End point title |
Ratio PV/HA [1] | |||||||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Ratio PV/HA measured at baseline (T1), post resection (T2) and pre reconstruction (T3)
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: no statistical analysis available |
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No statistical analyses for this end point |
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End point title |
P. Porta [2] | |||||||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
P. Porta measured at baseline (T1), post resection (T2) and pre reconstruction (T3)
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Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: no statistical analysis available |
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No statistical analyses for this end point |
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End point title |
P. Cava [3] | |||||||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
P. Cava measured at baseline (T1), post resection (T2) and pre reconstruction (T3)
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Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: no statistical analysis available |
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No statistical analyses for this end point |
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End point title |
Pulsatility Index (PI PV) [4] | |||||||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
PI PV measured at baseline (T1), post resection (T2) and pre reconstruction (T3)
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Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: no statistical analysis available |
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No statistical analyses for this end point |
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End point title |
Pulsatility Index (PI HA) [5] | |||||||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
PI HA measured at baseline (T1), post resection (T2) and pre reconstruction (T3)
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Notes [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: no statistical analysis available |
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No statistical analyses for this end point |
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End point title |
total HBF [6] | |||||||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Total HBF measured at baseline (T1), post-resection (T2) and pre-reconstruction (T3)
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Notes [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: no statistical analysis available |
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No statistical analyses for this end point |
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End point title |
PVF [7] | |||||||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
PVF measured at baseline (T1), post resection (T2) and pre reconstruction (T3)
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Notes [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: no statistical analysis available |
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No statistical analyses for this end point |
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End point title |
HAF [8] | |||||||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
HAF measured at baseline (T1), post resection (T2) and pre reconstruction (T3)
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Notes [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: no statistical analysis available |
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No statistical analyses for this end point |
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End point title |
Rel. HAF [9] | |||||||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Rel. HAF measured at baseline (T1), post resection (T2) and pre reconstruction (T3)
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Notes [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: no statistical analysis available |
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No statistical analyses for this end point |
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End point title |
Rel. PVF [10] | |||||||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Rel. PVF measured at baseline (T1), post resection (T2) and pre reconstruction (T3)
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Notes [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: no statistical analysis available |
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No statistical analyses for this end point |
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End point title |
Mean Arterial Pressure (MAP) | |||||||||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
MAP measured at baseline (T0 and T1), post resection (T2), pre reconstruction (T3) and end of surgery (T4)
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No statistical analyses for this end point |
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End point title |
Heart Rate (HR) | |||||||||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
HR measured at baseline (T0 and T1), post resection (T2), pre reconstruction (T3) and end of surgery (T4)
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No statistical analyses for this end point |
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End point title |
Central Venous Pressure (CVP) | |||||||||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
CVP measured at baseline (T0 and T1), post resection (T2), pre reconstruction (T3) and end of surgery (T4)
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No statistical analyses for this end point |
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End point title |
Cardiac Index (CI) | |||||||||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
CI measured at baseline (T0 and T1), post resection (T2), pre reconstruction (T3) and end of surgery (T4)
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No statistical analyses for this end point |
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End point title |
Pulse Pressure Variation (PPV) | |||||||||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
PPV measured at baseline (T0 and T1), post resection (T2), pre reconstruction (T3) and end of surgery (T4)
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No statistical analyses for this end point |
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End point title |
lactate | |||||||||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
lactate measured at baseline (T0 and T1), post resection (T2), pre reconstruction (T3) and end of surgery (T4)
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No statistical analyses for this end point |
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End point title |
PaCO2 | |||||||||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
PaCO2 measured at baseline (T0 and T1), post resection (T2), pre reconstruction (T3) and end of surgery (T4)
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No statistical analyses for this end point |
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End point title |
pH | |||||||||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
pH measured at baseline (T0 and T1), post resection (T2), pre reconstruction (T3) and end of surgery (T4)
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No statistical analyses for this end point |
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End point title |
amount of bloodloss | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
from start of surgery until end of surgery
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No statistical analyses for this end point |
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End point title |
amount of colloids given during surgery | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
from start of surgery until end of surgery
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No statistical analyses for this end point |
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End point title |
need of ephedrine | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
from start of anesthesia until end of anesthesia
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No statistical analyses for this end point |
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End point title |
need of phenylephrine | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
from start anesthesia until end of anesthesia
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No statistical analyses for this end point |
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End point title |
need of noradrenaline | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
from start of anesthesia until end of anesthesia
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
overall study
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Assessment type |
Non-systematic | |||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
CTCAE | |||||||||||||||||||||||||||||||||
Dictionary version |
5.0
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Reporting groups
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Reporting group title |
group S
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Reporting group description |
- | |||||||||||||||||||||||||||||||||
Reporting group title |
group P
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Reporting group description |
- | |||||||||||||||||||||||||||||||||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No non-serious adverse events were recorded for the participating patients |
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Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |