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    Clinical Trial Results:
    The Effect of Pregabalin on the Cp50 of Propofol

    Summary
    EudraCT number
    		 2021-003664-28
    Trial protocol
    		 AT  
    Global end of trial date
    20 Nov 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Apr 2026
    First version publication date
    03 Apr 2026
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Cp50PropofolPregabalin
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Waehringer Guertel 18-20, Vienna, Austria, 1090
    Public contact
    Department of Anaesthesia, Medical University of Vienna, walter.ploechl@meduniwien.ac.at
    Scientific contact
    Department of Anaesthesia, Medical University of Vienna, walter.ploechl@meduniwien.ac.at
    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
    20 Nov 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Nov 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Nov 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study aims to investigate the effect of a clinically used dose of Pregabalin on the Cp50 of propofol to provide more information to clinicians using this adjunctive drug in the perioperative setting.
    Protection of trial subjects
    Medical insurance for trial subjects
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Aug 2022
    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
    Austria: 88
    Worldwide total number of subjects
    88
    EEA total number of subjects
    88
    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)
    88
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 We recruited only adult patients with an American Society of Anesthesiologists (ASA) physical status of I or II who were scheduled for elective surgery. For standardization, we included only female patients who underwent breast surgery. Furthermore, patients were required to be between 25 and 65 years old with a body mass index betwen 18.5-30

    Pre-assignment
    Screening details
    		 OR schedule was checked for eligibility

    Period 1
    Period 1 title
    active phase (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Placebo capsule 1-2 hours before surgery
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1 capsule, 1-2 hours before surgery

    Arm title
    		 Pregabalin
    Arm description
    		 Pregabalin 300mg capsule 1-2 hours before surgery
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Pregabalin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    300mg Pregabalin capsule 1-2 hours before surgery

    Number of subjects in period 1
    		Placebo Pregabalin
    Started
    45
    43
    Completed
    40
    40
    Not completed
    5
    3
         Organisation
    5
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo capsule 1-2 hours before surgery

    Reporting group title
    Pregabalin
    Reporting group description
    		 Pregabalin 300mg capsule 1-2 hours before surgery

    Reporting group values
    		 Placebo Pregabalin Total
    Number of subjects
    		 45 43 88
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 45 43 88
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 45 43 88
        Male
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo capsule 1-2 hours before surgery

    Reporting group title
    Pregabalin
    Reporting group description
    		 Pregabalin 300mg capsule 1-2 hours before surgery

    Subject analysis set title
    CP50
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    After anesthesia induction, propofol continued to be the sole anesthetic agent and was continuously administered via a motor pump. The surgical site was then cleaned and prepared. Propofol infusion was maintained for at least 20 minutes to reach equilibrium between the effect-site and plasma. Subsequently, the surgeon made a standardized skin incision of 3 to 5 cm, depending on the exact location of the incision and type of operation. Two blinded investigators observed patients’ motor responses to the skin incision for 1 minute. One investigator assessed the head and upper extremities, while the other observed the lower extremities. If either investigator reported gross purposeful movement of the head or at least one extremity within 1 minute, the motor response was classified as “positive.” Coughing, bucking, and straining were not considered. If there was no movement, it was considered a negative response.

    Primary: CP50

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    End point title
    		 CP50
    End point description
    End point type
    Primary
    End point timeframe
    20 min.
    End point values
    		 Placebo Pregabalin
    Number of subjects analysed
    45
    43
    Units: mcg/ml
        number (confidence interval 95%)
    16.9 (15.1 to 18.8)
    9.4 (4.5 to 14.3)
    Statistical analysis title
    		 CP50
    Comparison groups
    Placebo v Pregabalin
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0
    Method
    		 Logistic regression amd bootstrap
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    4 hours
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    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: There was no adverse events

    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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