Clinical Trial Results:
Stressi-indeksi (SSI) sevofluraani-alfentaniilianestesiassa
Summary
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EudraCT number |
2006-003765-14 |
Trial protocol |
FI |
Global end of trial date |
04 May 2007
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Results information
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Results version number |
v1(current) |
This version publication date |
02 Mar 2019
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First version publication date |
02 Mar 2019
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Other versions |
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Summary report(s) |
Summary Stressi-indeksi (SSI) sevofluraani-alfentaniilianestesiassa |
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 |
SSIVALTA0706
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
GE Healthcare Finland Oy
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Sponsor organisation address |
Kuortaneenkatu 2, Helsinki, Finland,
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Public contact |
Kimmo Uutela, ALFESEVOSSI01.txt, +358 405732817, kimmo.uutela@ge.com
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Scientific contact |
Kimmo Uutela, ALFESEVOSSI01.txt, +358 405732817, kimmo.uutela@ge.com
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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 |
23 Aug 2007
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
21 Nov 2006
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Global end of trial reached? |
Yes
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Global end of trial date |
04 May 2007
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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 |
Tutkia stressi-indeksin herkkyyttä analgeettiselle lääkitykselle (alfentaniili)
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Protection of trial subjects |
Normal surgery procedure
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
18 Sep 2006
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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 |
Finland: 40
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Worldwide total number of subjects |
40
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EEA total number of subjects |
40
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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) |
33
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From 65 to 84 years |
7
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85 years and over |
0
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Recruitment
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Recruitment details |
- | |||||||||
Pre-assignment
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Screening details |
Inclusion: Age 18-80, ASAI-III, general anesthesia Exclusion: Allergy to used drugs | |||||||||
Period 1
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Period 1 title |
Baseline (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Single blind | |||||||||
Roles blinded |
Subject | |||||||||
Blinding implementation details |
Surgical drug variation blinded from patient but not from caregiver
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Alfentanil change | |||||||||
Arm description |
- | |||||||||
Arm type |
Drug variation | |||||||||
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 |
Injection
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Routes of administration |
Intravenous use
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Dosage and administration details |
Effect-site concentration control
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Arm title
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Sevoflurane change | |||||||||
Arm description |
Sevoflurane change | |||||||||
Arm type |
Drug change | |||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Baseline characteristics reporting groups
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Reporting group title |
Alfentanil change
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Sevoflurane change
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Reporting group description |
Sevoflurane change | ||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Alfentanil change
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Reporting group description |
- | ||
Reporting group title |
Sevoflurane change
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Reporting group description |
Sevoflurane change |
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End point title |
SSi Change [1] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
During surgery
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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: Measuring change within group, not comparing between |
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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 |
End of study
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Assessment type |
Non-systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
None | ||
Dictionary version |
0
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Frequency threshold for reporting non-serious adverse events: 5% | |||
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 serious adverse events |
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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 |