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    Clinical Trial Results:
    Propofol TCI (Target Controlled Infusion) vs. Midazolam plus Fentanyl for moderate sedation during gastrointestinal procedures: a double-blind randomized controlled trial.

    Summary
    EudraCT number
    		 2012-001755-40
    Trial protocol
    		 IT  
    Global end of trial date
    04 Mar 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 May 2021
    First version publication date
    13 May 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Prop/TCI/2012
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02062177
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    IRCCS Ospedale San Raffaele
    Sponsor organisation address
    Via Olgettina, 60, Milano, Italy, 20132
    Public contact
    Division of Gastroenterology and Gastrointestinal Endoscopy, IRCCS Ospedale San Raffaele, 0039 0226432744, fanti.lorella@hsr.it
    Scientific contact
    Division of Gastroenterology and Gastrointestinal Endoscopy, IRCCS Ospedale San Raffaele, 0039 0226432744, fanti.lorella@hsr.it
    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 Mar 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Mar 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare propofol TCI and midazolam i.v. boluses with respect to their effectiveness and safety for maintaining moderate sedation during esophagogastroduodenoscopies (EGD) and colonoscopies. Both sedation regimens were administered bythe endoscopist.
    Protection of trial subjects
    Approval by the local Ethics Committee was obtained before the beginning of the study and written informed consent was obtained from all patients at time of enrolment. All procedures were performed by a single experienced endoscopist using a standard technique with a high definition videoendoscope. The endoscopist had performed more than 100 propofol sedations during endoscopy before. All medical and nursing staff members are ACLS-certified and have received non-anaesthesiologist training for sedation for gastrointestinal endoscopy, including the basic principles of sedation and practical training in NAPS. During colonoscopy, moderate sedation was maintained throughout the scope-in phase, the most painful phase of the procedure, whereas sedative administration was discontinued upon caecal intubation. During EGD, sedative administration was discontinued uponcompletion of the exam.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 May 2012
    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
    Italy: 140
    Worldwide total number of subjects
    140
    EEA total number of subjects
    140
    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)
    105
    From 65 to 84 years
    35
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This randomized double-blind controlled trial involved 140 consecutive outpatients scheduled to undergo EGD or colonoscopy. On arrival in the endoscopy suite patients were randomly assigned to one of two groups according to a previously computer-generated list

    Pre-assignment
    Screening details
    		 On patient’s arrival in the endoscopy suite a peripheral intravenous cannula was inserted. Throughout endoscopy electrocardiogram and pulse oximetry (SpO2) were continuously monitored, and non-invasive arterial blood pressure was monitored every 5 min

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    Sedation was administered, under the endoscopist’s supervision, by a gastroenterology attending fellow (GR) not directly involved in the procedure, who was the only one not blinded towards the randomized sedation regimen. Because of the well-known different physical appearance of study drugs, a fabric curtain was drawn across the patient’s arm, concealing the i.v. line and the TCI pump both to the patient and to the endoscopist.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group S (Standard Sedation)
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Midazolam
    Investigational medicinal product code
    IPNOVEL
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    Intravenous bolus 0.04 mg/kg if aged <70, 0.03 mg/kg if aged >=70, followed by 1 mg i.v. bolus up to a maximum of 5 mg.

    Investigational medicinal product name
    Fentanyl
    Investigational medicinal product code
    FENTANYL
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients in both groups (Group S and Group P) undergoing colonoscopy received also i.v. fentanyl (1 ug/kg) for pain control.

    Arm title
    		 Group P (Propofol TCI Sedation)
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Propofol
    Investigational medicinal product code
    DIPRIVAN
    Other name
    Pharmaceutical forms
    Emulsion for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Target concentration was initially set at 1.2–1.6 g/ml (side effect concentration), according topatient’s body weight and general condition, then titrated with 0.1 ug/ml increments up to a maximum of 2 ug/ml.

    Number of subjects in period 1
    		Group S (Standard Sedation) Group P (Propofol TCI Sedation)
    Started
    70
    70
    Completed
    70
    70

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 140 140
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 0 ( 0 ) -
    Gender categorical
    Units: Subjects
        Female
    		 62 62
        Male
    		 78 78
    Subject analysis sets

    Subject analysis set title
    Group S - EGD
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Seventy consecutive patients, undergoing EGD were prospectively enrolled and randomized (Group S)

    Subject analysis set title
    Group P - EGD
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Seventy consecutive patients, undergoing EGD were prospectively enrolled and randomized (Group P)

    Subject analysis set title
    Group S - Colonoscopy
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Seventy consecutive patients undergoing colonoscopy were prospectively randomized (Group S)

    Subject analysis set title
    Group P - Colonoscopy
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Seventy consecutive patients undergoing colonoscopy were prospectively randomized (Group P)

    Subject analysis sets values
    		 Group S - EGD Group P - EGD Group S - Colonoscopy Group P - Colonoscopy
    Number of subjects
    35
    35
    35
    35
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    52.3 ( 18.1 )
    47.8 ( 17.5 )
    58.6 ( 11.6 )
    57.2 ( 13.8 )
    Gender categorical
    Units: Subjects
        Female
    13
    14
    19
    16
        Male
    22
    21
    16
    19

    End points

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    End points reporting groups
    Reporting group title
    Group S (Standard Sedation)
    Reporting group description
    		 -

    Reporting group title
    Group P (Propofol TCI Sedation)
    Reporting group description
    		 -

    Subject analysis set title
    Group S - EGD
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Seventy consecutive patients, undergoing EGD were prospectively enrolled and randomized (Group S)

    Subject analysis set title
    Group P - EGD
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Seventy consecutive patients, undergoing EGD were prospectively enrolled and randomized (Group P)

    Subject analysis set title
    Group S - Colonoscopy
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Seventy consecutive patients undergoing colonoscopy were prospectively randomized (Group S)

    Subject analysis set title
    Group P - Colonoscopy
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Seventy consecutive patients undergoing colonoscopy were prospectively randomized (Group P)

    Primary: Patient Satisfaction (VAS)

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    End point title
    		 Patient Satisfaction (VAS)
    End point description
    When completely awake, patients were asked to rate the pain/disconfort they experienced and their satisfaction about sedation on a 100 mm visual analogue scale (VAS)
    End point type
    Primary
    End point timeframe
    40 minutes
    End point values
    		 Group S - EGD Group P - EGD Group S - Colonoscopy Group P - Colonoscopy
    Number of subjects analysed
    35
    35
    35
    35
    Units: millimeter(s)
        arithmetic mean (standard deviation)
    76.5 ( 25.2 )
    93.8 ( 18.2 )
    85.5 ( 14.4 )
    95 ( 9.3 )
    Statistical analysis title
    		 Groups comparation
    Comparison groups
    Group S - EGD v Group P - EGD v Group S - Colonoscopy v Group P - Colonoscopy
    Number of subjects included in analysis
    140
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Endoscopist Satisfaction (VAS)

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    End point title
    		 Endoscopist Satisfaction (VAS)
    End point description
    A 100 mm visual analogue scale (VAS) was used by the gastroenterology fellow to assess technical diffi-culty of examination and satisfaction with sedation as reported bythe endoscopist
    End point type
    Secondary
    End point timeframe
    At the end of the procedure
    End point values
    		 Group S - EGD Group P - EGD Group S - Colonoscopy Group P - Colonoscopy
    Number of subjects analysed
    35
    35
    35
    35
    Units: millimeter(s)
        arithmetic mean (standard deviation)
    82.8 ( 21.2 )
    92.7 ( 14.3 )
    87.2 ( 12 )
    98.3 ( 11.4 )
    Statistical analysis title
    		 Groups comparation
    Comparison groups
    Group S - EGD v Group P - EGD v Group S - Colonoscopy v Group P - Colonoscopy
    Number of subjects included in analysis
    140
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Patient Satisfaction (VAS) 24h

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    End point title
    		 Patient Satisfaction (VAS) 24h
    End point description
    Patients were contacted by telephone 24–72 h after dischargeand asked again about their satisfaction about sedation, rated on averbal rating scale (0 = no satisfaction; 100 = complete satisfaction)
    End point type
    Secondary
    End point timeframe
    24-72 h after the procedures
    End point values
    		 Group S - EGD Group P - EGD Group S - Colonoscopy Group P - Colonoscopy
    Number of subjects analysed
    35
    35
    35
    35
    Units: millimeter(s)
        arithmetic mean (standard deviation)
    77.3 ( 27.2 )
    92.6 ( 20.2 )
    87.7 ( 16.2 )
    97.3 ( 9.3 )
    Statistical analysis title
    		 Groups comparation
    Comparison groups
    Group S - EGD v Group P - EGD v Group S - Colonoscopy v Group P - Colonoscopy
    Number of subjects included in analysis
    140
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Time to discharge

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    End point title
    		 Time to discharge
    End point description
    End point type
    Secondary
    End point timeframe
    At discharge
    End point values
    		 Group S - EGD Group P - EGD Group S - Colonoscopy Group P - Colonoscopy
    Number of subjects analysed
    35
    35
    35
    35
    Units: minute
        arithmetic mean (standard deviation)
    3.9 ( 9.2 )
    1.1 ( 0.7 )
    5 ( 10.2 )
    1.1 ( 0.3 )
    Statistical analysis title
    		 Groups comparation
    Comparison groups
    Group S - EGD v Group P - EGD v Group S - Colonoscopy v Group P - Colonoscopy
    Number of subjects included in analysis
    140
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Repeat Endoscopy

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    End point title
    		 Repeat Endoscopy
    End point description
    Patients were contacted by telephone 24–72 h after dischargeand asked if they would request the same anaestheticregimen for future endoscopies.
    End point type
    Secondary
    End point timeframe
    24-72 h after discharge
    End point values
    		 Group S - EGD Group P - EGD Group S - Colonoscopy Group P - Colonoscopy
    Number of subjects analysed
    35
    35
    35
    35
    Units: percent
        number (not applicable)
    71.4
    94.3
    85.7
    97.1
    Statistical analysis title
    		 Groups comparation
    Comparison groups
    Group S - EGD v Group P - EGD v Group S - Colonoscopy v Group P - Colonoscopy
    Number of subjects included in analysis
    140
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From enrolment to 24-72h after discharge
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    3.0
    Reporting groups
    Reporting group title
    Group S (Standard Sedation)
    Reporting group description
    		 -

    Reporting group title
    Group P (Propofol TCI Sedation)
    Reporting group description
    		 -

    Serious adverse events
    		 Group S (Standard Sedation) Group P (Propofol TCI Sedation)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 70 (0.00%)
    0 / 70 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Group S (Standard Sedation) Group P (Propofol TCI Sedation)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 70 (10.00%)
    1 / 70 (1.43%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    3 / 70 (4.29%)
    1 / 70 (1.43%)
         occurrences all number
    99999999
    99999999
    Bradycardia
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 70 (0.00%)
         occurrences all number
    99999999
    99999999
    Respiratory, thoracic and mediastinal disorders
    Hypoxia
         subjects affected / exposed
    3 / 70 (4.29%)
    0 / 70 (0.00%)
         occurrences all number
    99999999
    99999999

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/25840875
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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
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