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    Clinical Trial Results:
    Can we get conscious sedation in optimal safety conditions in an emergency department, by combining dexmedetomidine with ketamine?

    Summary
    EudraCT number
    		 2014-005170-11
    Trial protocol
    		 BE  
    Global end of trial date
    01 Mar 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Mar 2021
    First version publication date
    27 Mar 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    UCLDexAlf1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02358057
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Cliniques universitaires Saint-Luc
    Sponsor organisation address
    Avenue Hippocrate, 10, Brussels, Belgium, 1200
    Public contact
    Franck Verschuren, Cliniques universitaires Saint-Luc, +32 27648080, franck.verschuren@uclouvain.be
    Scientific contact
    Franck Verschuren, Cliniques universitaires Saint-Luc, +32 27648080, franck.verschuren@uclouvain.be
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    02 Jan 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Mar 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Mar 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective is to determine if combinaison of dexmédétomidine and Ketamine allows a level of conscious sedation within maximum security conditions in an emergency department.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) regulations/guidelines, United States Food and Drug Administration (FDA) regulations/guidelines, and country-specific national and local laws.
    Background therapy
    		 Patients included in the study received an infusion of dexmedetomidine via a TIVA Injectomat Agilia syringe pump, specially programmed for the injection of dexmedetomidine. At time zero, the patient receives a bolus of 1 mcg / kg dexmedetomidine for 10 minutes. Patients over 65 received a bolus of 0.5 mcg / kg dexmedetomidine for 10 minutes. Then the patient will receive a continuous injection of 0.6 mcg / kg / h of dexmedetomidine Patients
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Jan 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 30
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    16
    From 65 to 84 years
    12
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between October 2015 and September 2016, 30 patients were recruited from a single site in Belgium (Cliniques Universitaires Saint-Luc Bruxelles).

    Pre-assignment
    Screening details
    		 Patients arriving in the emergency room and requiring procedural sedation while meeting study inclusion criteria were approached to participate in the study. A clear and complete explanation was provided to them and an informed consent was signed by the patient.

    Period 1
    Period 1 title
    Full study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Dexmedetomidine and Ketamine
    Arm description
    		 Patients included in the study received an infusion of dexmedetomidine via a TIVA Injectomat Agilia syringe pump, specially programmed for the injection of dexmedetomidine. At time zero, the patient receives a bolus of 1 mcg / kg dexmedetomidine for 10 minutes. Patients over 65 received a bolus of 0.5 mcg / kg dexmedetomidine for 10 minutes. Then the patient will receive a continuous injection of 0.6 mcg / kg / h of dexmedetomidine
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dexmedetomidine
    Investigational medicinal product code
    Other name
    Dexdor, Precedex
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    At time zero, the patient receives a bolus of 1 mcg / kg dexmedetomidine for 10 minutes. Patients over 65 received a bolus of 0.5 mcg / kg dexmedetomidine for 10 minutes. Then the patient will receive a continuous injection of 0.6 mcg / kg / h of dexmedetomidine

    Investigational medicinal product name
    ketamine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients will also receive a dose of kétamine1 mg /kg, 1 minute before the technical act. Patients over 65 received a dose of 0.5 mg / kg

    Number of subjects in period 1
    		Dexmedetomidine and Ketamine
    Started
    30
    Completed
    30

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Full study
    Reporting group description
    		 -

    Reporting group values
    		 Full study Total
    Number of subjects
    		 30 30
    Age categorical
    Patients received combination of Dexmedetomidine and Ketamine
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 16 16
        From 65-84 years
    		 12 12
        85 years and over
    		 2 2
    Age continuous
    Patients received combination of Dexmedetomidine and Ketamine
    Units: years
        arithmetic mean (standard deviation)
    		 58.27 ± 21.25 -
    Gender categorical
    Patients received combination of Dexmedetomidine and Ketamine
    Units: Subjects
        Female
    		 19 19
        Male
    		 11 11

    End points

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    End points reporting groups
    Reporting group title
    Dexmedetomidine and Ketamine
    Reporting group description
    		 Patients included in the study received an infusion of dexmedetomidine via a TIVA Injectomat Agilia syringe pump, specially programmed for the injection of dexmedetomidine. At time zero, the patient receives a bolus of 1 mcg / kg dexmedetomidine for 10 minutes. Patients over 65 received a bolus of 0.5 mcg / kg dexmedetomidine for 10 minutes. Then the patient will receive a continuous injection of 0.6 mcg / kg / h of dexmedetomidine

    Primary: Ramsay score scale

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    End point title
    		 Ramsay score scale [1]
    End point description
    1. Can we obtain an adequate level of sedation with dexmedetomidine and ketamine in an emergency department? The Ramsay score scale will evaluate the sedation level. The objective is to reach a score of 2 or 3 on the Ramsay score scale. 2. Can we do a procedural sedation with dexmedetomidine in optimal safety conditions in an emergency department? The optimal safety conditions are determined by: 1. A stable blood pressure 2. A stable heart rhythm 3. No respiratory depression 4. Absence of hypoxia 5. Absence of vomiting
    End point type
    Primary
    End point timeframe
    The time for carrying out procedural sedation and post-sedation monitoring. A satisfaction survey was carried out by telephone one week after performing the procedural sedation.
    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: Only descriptive statistics were performed
    End point values
    		 Dexmedetomidine and Ketamine
    Number of subjects analysed
    30
    Units: number
        Ramsay score 2 or 3
    0
        Ramsay score 4 or 5
    30
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    In the event of major side effects, the patient was monitored in the intensive care unit. In case of suspicion of inhalation with stable hemodynamic and respiratory parameters, the patient was hospitalized in the internal medicine unit for monitoring and
    Adverse event reporting additional description
    In the event of a serious adverse event, the patient was treated according to international guidelines. Finally, a continuous assessment of the benefit / risk ratio was carried out throughout our study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE GRADE
    Dictionary version
    4.03
    Reporting groups
    Reporting group title
    Dexmedetomidine and Ketamine
    Reporting group description
    		 Patients received combination of Dexmedetomidine and Ketamine.

    Serious adverse events
    		 Dexmedetomidine and Ketamine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 30 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Dexmedetomidine and Ketamine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 30 (40.00%)
    Vascular disorders
    Arterial hypertension
    Additional description: During sedation
         subjects affected / exposed
    7 / 30 (23.33%)
         occurrences all number
    1
    Arterial hypotension
    Additional description: Complication in the recovery room
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Orthostatism
    Additional description: Complication in the recovery room
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Nervous system disorders
    dizziness
    Additional description: Complication in the recovery room
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Gastrointestinal disorders
    Vomiting
    Additional description: Complication in the recovery room
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Apnea with saturation
    Additional description: During sedation
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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