Clinical Trial Results:
Dexmedetomidine in awake implantation of neuromodulative systems.
Summary
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EudraCT number |
2014-001587-35 |
Trial protocol |
NL |
Global end of trial date |
16 Feb 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
26 Jan 2020
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First version publication date |
26 Jan 2020
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Other versions |
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Summary report(s) |
Dexmedetomidine in awake implantation of neuromodulative system |
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 |
Feline01
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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 |
Erasmus MC
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Sponsor organisation address |
Doctor Molewaterplein 40, Rotterdam, Netherlands,
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Public contact |
Prof. Dr. F.J.P.M. Huygen, Erasmus Medical Centre, Department of Anesthesiology, f.huygen@erasmusmc.nl
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Scientific contact |
Prof. Dr. F.J.P.M. Huygen, Erasmus Medical Center, Department of Anesthesiology, f.huygen@erasmusmc.nl
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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 |
20 Jun 2015
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
16 Feb 2015
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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 |
Patient overall satisfaction.
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Protection of trial subjects |
Yes
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Sep 2014
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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 |
Netherlands: 10
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Worldwide total number of subjects |
10
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EEA total number of subjects |
10
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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) |
10
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Recruitment period from 01/09/2014 till 10/02/2015 | ||||||
Pre-assignment
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Screening details |
Inclusion criteria: patients aged 18-65 years with an indication for a neurostimulation system | ||||||
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 |
Not applicable
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Blinding used |
Not blinded | ||||||
Blinding implementation details |
Not applicable
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Arms
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Arm title
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Arm 1 | ||||||
Arm description |
Dexmedetomidine infusion | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Dexmedetomidine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Emulsion for infusion in administration system
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Routes of administration |
Intravenous use
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Dosage and administration details |
1 mcg/kg over 10 minutes, followed by 0.6 mcg/kg/hour
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End points reporting groups
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Reporting group title |
Arm 1
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Reporting group description |
Dexmedetomidine infusion |
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End point title |
Patient satisfaction [1] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Within the admission of the patient to the hospital post-operative
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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: Statistical analysis Descriptive statistics were used to determine the frequencies of the demographic variables and the outcome parameters, and to describe measures of central tendency and of variability, depending on the shape of the distribution. All analyses were performed using IBM SPSS Statistics version 21 (Armonk, NY, USA). |
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No statistical analyses for this end point |
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End point title |
Pain relief | ||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Perioperative
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No statistical analyses for this end point |
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End point title |
patients comfort | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Postoperative
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No statistical analyses for this end point |
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End point title |
operators comfort | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Postoperative
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No statistical analyses for this end point |
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End point title |
number of adjustements made in dexmedetomidine infusion | ||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Perioperative
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No statistical analyses for this end point |
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End point title |
Ramsey score | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Prioperative
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No statistical analyses for this end point |
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End point title |
intraoperative standard hemodynamic and respiratory monitoring | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
perioperative
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Perioperative period
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Assessment type |
Systematic | ||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
not applicable | ||||||||||||||
Dictionary version |
0
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Reporting groups
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Reporting group title |
All patients
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Reporting group description |
- | ||||||||||||||
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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 | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/26914618 |