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    Clinical Trial Results:
    Effect site controlled, reaction time safeguarded, patient maintained sedation with Propofol A) in oral surgery patients B) in general dentistry patients C) in colonoscopy patients

    Summary
    EudraCT number
    		 2005-005758-39
    Trial protocol
    		 GB  
    Global end of trial date
    11 Feb 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Apr 2019
    First version publication date
    13 Apr 2019
    Other versions
    Summary report(s)
    		 2005-005758-39 summary

    Trial information

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    Trial identification
    Sponsor protocol code
    9812/A
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Sponsor reference: WN06AN024
    Sponsors
    Sponsor organisation name
    NHS Greater Glasgow and Clyde
    Sponsor organisation address
    Clinical Research & Development, West Glasgow Ambulatory Care Hospital, Dalnair Street, Glasgow, United Kingdom, G3 8SW
    Public contact
    Dr Debra Stuart, NHS Greater Glasgow and Clyde, debra.stuart@glasgow.ac.uk
    Scientific contact
    Dr Debra Stuart, NHS Greater Glasgow and Clyde, debra.stuart@glasgow.ac.uk
    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
    04 Apr 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Feb 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Feb 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess whether patient-maintained sedation (the patient controls his/her degree of sedation using a hand-held device) using the drug propofol is safer and more effective when using deteriorating reaction time as an added safeguard against the potential for oversedation in groups of patients undergoing dental surgery and colonoscopy.
    Protection of trial subjects
    The routine use of propofol traditionally is restricted to anaesthetists, as in high doses general anaesthesia is produced with possible loss of airway patency. Currently the safety feature is predominantly that as patients become more sedated they cannot press the patient demand button and hence cannot increase the amount of propofol they are receiving. Also the device ensures that the blood and brain concentrations have equilibrated to within 10% of each other before another successful demand for propofol can be made (usually takes approximately two minutes) and it only allows a maximum calculated brain concentration of 3 micrograms/milliliter of propofol. The device also will start to decrease the calculated brain concentration of propofol if the demand button has not been pressed for six minutes.
    Background therapy
    		 N/A
    Evidence for comparator
    		 N/A
    Actual start date of recruitment
    06 Dec 2006
    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
    United Kingdom: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    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)
    20
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Healthy patients (ASA physical status 1-2) receiving sedation while undergoing oral surgery recruited via NHS clinics in the United Kingdom

    Pre-assignment
    Screening details
    		 Inclusion Criteria ASA I-II (healthy or only mild systemic illness) undergoing planned dental surgery or colonoscopy; Age 18-65yrs Exclusion Criteria ASA III or above; Outwith age group above; Contraindication to Propofol; History of epilepsy; History of substance abuse; Major Psychiatric illness; Pregnancy or breastfeeding; Unable to consent

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    n/a

    Arms
    Arm title
    		 Oral Surgery
    Arm description
    		 oral surgery patients
    Arm type
    		 Experimental

    Investigational medicinal product name
    Propofol
    Investigational medicinal product code
    Other name
    Diprivan
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1% = 10mg/ml. Target Controlled Infusion (50ml prefilled syringe)

    Number of subjects in period 1
    		Oral Surgery
    Started
    20
    Completed
    20

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Oral Surgery
    Reporting group description
    		 oral surgery patients

    Reporting group values
    		 Oral Surgery Total
    Number of subjects
    		 20 20
    Age categorical
    Adults
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 35.0 ( 14.7 ) -
    Gender categorical
    Units: Subjects
        Female
    		 17 17
        Male
    		 3 3
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 72.6 ( 14.7 ) -

    End points

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    End points reporting groups
    Reporting group title
    Oral Surgery
    Reporting group description
    		 oral surgery patients

    Primary: Minimal sedation level

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    End point title
    		 Minimal sedation level [1]
    End point description
    Observer's Assessment of Alertness Sedation score Range: 1 (unresponsive) to 5 (fully awake)
    End point type
    Primary
    End point timeframe
    Treatment period
    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: Pilot single group, prospective, phase IV study; no formal statistical analysis performed. Descriptive statistics only reported.
    End point values
    		 Oral Surgery
    Number of subjects analysed
    20
    Units: number
        score 1
    0
        score 2
    0
        score 3
    0
        score 4
    9
        score 5
    11
    No statistical analyses for this end point

    Post-hoc: Time for sedation

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    End point title
    		 Time for sedation
    End point description
    End point type
    Post-hoc
    End point timeframe
    Treatment period
    End point values
    		 Oral Surgery
    Number of subjects analysed
    20
    Units: minutes
        arithmetic mean (standard deviation)
    25 ( 11 )
    No statistical analyses for this end point

    Post-hoc: Maximum propofol effect-site concentration

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    End point title
    		 Maximum propofol effect-site concentration
    End point description
    End point type
    Post-hoc
    End point timeframe
    Treatment period
    End point values
    		 Oral Surgery
    Number of subjects analysed
    20
    Units: microgram(s)/millilitre
        arithmetic mean (standard deviation)
    1.6 ( 0.5 )
    No statistical analyses for this end point

    Post-hoc: Lowest oxygen saturation

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    End point title
    		 Lowest oxygen saturation
    End point description
    End point type
    Post-hoc
    End point timeframe
    Treatment period
    End point values
    		 Oral Surgery
    Number of subjects analysed
    20
    Units: SaO2%
        arithmetic mean (standard deviation)
    98.0 ( 2.1 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Initiation of sedation to discharge following the surgical procedure.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17
    Reporting groups
    Reporting group title
    Participant group
    Reporting group description
    		 -

    Serious adverse events
    		 Participant group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (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
    		 Participant group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    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 adverse events were reported, confirmed by the PI to the CI on 22/08/2007

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Aug 2008
    Change of Chief Investigator

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/24044388
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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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