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    Clinical Trial Results:
    An investigation of postoperative pain, why still in hospital and days alive and out of hospital following transoral robotic surgery for squamous cell carcinoma of unknown primary and obstructive sleep apnea

    Summary
    EudraCT number
    		 2019-004610-34
    Trial protocol
    		 DK  
    Global end of trial date
    09 Nov 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Oct 2023
    First version publication date
    28 Oct 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    DexaCup
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04189107
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Rigshospitalet
    Sponsor organisation address
    Inge Lehmanns vej, Copenhagen, Denmark,
    Public contact
    Mikkel Larsen, Rigshospitalet, Department of Otorhinolaryngology, Head and Neck Surgery & Audiology, 45 35452071, mikkel.hjordt.holm.larsen@regionh.dk
    Scientific contact
    Mikkel Larsen, Rigshospitalet, Department of Otorhinolaryngology, Head and Neck Surgery & Audiology, 45 35452071, mikkel.hjordt.holm.larsen@regionh.dk
    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 Jun 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Nov 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Nov 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the effect of high dose steroids on the postoperative pain level measured by self-assessed VAS during rest and swallowing following transoral robotic surgery
    Protection of trial subjects
    Dexamethasone is a commonly used and safe drug used to reduce PONV. The analgesic effect of dexamethasone has previously only been sparsely studied in patients undergoing transoral robotic surgery. In this RCT we compared the effect of high vs low dose dexamethasone on patient reported pain. All adverse effects were monitored and reported. patients with contraindications for dexamethasone therapy were not included. The trial was monitored by the local GCP unit.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Jun 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 18
    Worldwide total number of subjects
    18
    EEA total number of subjects
    18
    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)
    13
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The first patient was included and randomized 17th of August 2020 and the last patient was included and randomized 13th of October 2022. A total of 18 patients were included and randomized with 9 patients in each arm

    Pre-assignment
    Screening details
    		 a total of 22 patients were screened. 4 patients were excluded as they declined participation or fulfilled a exclusion criteria

    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, Monitor, Assessor
    Blinding implementation details
    Dexamethasone was delivered in blinded packages from a pharmacy. thus the treatment was blinded to all involved personnel and subjects.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 High dose
    Arm description
    		 Patients undergoing transoral robotic resection lingual tonsillectomy as part of the diagnostic workup for carcinoma of unknown primary or in the treatment of obstructive sleep apnea were randomized to either 24 mg dexamethasone intraoperatively vs 8 mg intraoperatively followed by either 12mg on pod2 and pod 4 vs placebo on pod2 and pod4.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    the solution was delivered in 4mg/ml dexamethasone. Patient in the high dose group thus received 6mL intraoperatively and 3mL on POD2 and 4. patients in the low dose group received 2mL intraoperatively and placebo (sodium chloride) 4mL followed by 3 mL of sodium chloride on POD2 and 4

    Arm title
    		 low dose
    Arm description
    		 Patients undergoing transoral robotic resection lingual tonsillectomy as part of the diagnostic workup for carcinoma of unknown primary or in the treatment of obstructive sleep apnea were randomized to either 24 mg dexamethasone intraoperatively vs 8 mg intraoperatively followed by either 12mg on pod2 and pod 4 vs placebo on pod2 and pod4.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		High dose low dose
    Started
    9
    9
    Completed
    9
    9

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    High dose
    Reporting group description
    		 Patients undergoing transoral robotic resection lingual tonsillectomy as part of the diagnostic workup for carcinoma of unknown primary or in the treatment of obstructive sleep apnea were randomized to either 24 mg dexamethasone intraoperatively vs 8 mg intraoperatively followed by either 12mg on pod2 and pod 4 vs placebo on pod2 and pod4.

    Reporting group title
    low dose
    Reporting group description
    		 Patients undergoing transoral robotic resection lingual tonsillectomy as part of the diagnostic workup for carcinoma of unknown primary or in the treatment of obstructive sleep apnea were randomized to either 24 mg dexamethasone intraoperatively vs 8 mg intraoperatively followed by either 12mg on pod2 and pod 4 vs placebo on pod2 and pod4.

    Reporting group values
    		 High dose low dose Total
    Number of subjects
    		 9 9 18
    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)
    		 6 7 13
        From 65-84 years
    		 3 2 5
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 58.22 ± 11.84 56.56 ± 12.34 -
    Gender categorical
    Units: Subjects
        Female
    		 0 1 1
        Male
    		 9 8 17
    TORS indication
    Units: Subjects
        CUP
    		 6 8 14
        OSAS
    		 3 1 4
    Smoking status
    Units: Subjects
        0-10 pack-years
    		 4 5 9
        >10 pack years
    		 4 3 7
        unknown
    		 1 1 2
    Alcohol consumption
    Units: Subjects
        >14 units(men)/>7 units(women)
    		 0 1 1
        </=14 units(men)/</=7 units(women)
    		 6 7 13
        unknown
    		 3 1 4
    Charlton comorbidity index
    Units: CCI
        median (inter-quartile range (Q1-Q3))
    		 0 (0 to 0) 0 (0 to 0) -
    Preoperative VAS rest morning
    Units: VAS
        median (inter-quartile range (Q1-Q3))
    		 0 (0 to 0) 0 (0 to 2) -
    Preoperative VAS swallowing morning
    Units: VAS
        median (inter-quartile range (Q1-Q3))
    		 0 (0 to 1) 0 (0 to 1) -
    Preoperative VAS rest evening
    Units: VAS
        median (inter-quartile range (Q1-Q3))
    		 0 (0 to 0) 0 (0 to 1) -
    Preoperative VAS swallowing evening
    Units: VAS
        median (inter-quartile range (Q1-Q3))
    		 0 (0 to 1) 0 (0 to 1) -
    TORS Duration
    Units: minute
        median (inter-quartile range (Q1-Q3))
    		 60.0 (45 to 66) 67 (54 to 114) -

    End points

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    End points reporting groups
    Reporting group title
    High dose
    Reporting group description
    		 Patients undergoing transoral robotic resection lingual tonsillectomy as part of the diagnostic workup for carcinoma of unknown primary or in the treatment of obstructive sleep apnea were randomized to either 24 mg dexamethasone intraoperatively vs 8 mg intraoperatively followed by either 12mg on pod2 and pod 4 vs placebo on pod2 and pod4.

    Reporting group title
    low dose
    Reporting group description
    		 Patients undergoing transoral robotic resection lingual tonsillectomy as part of the diagnostic workup for carcinoma of unknown primary or in the treatment of obstructive sleep apnea were randomized to either 24 mg dexamethasone intraoperatively vs 8 mg intraoperatively followed by either 12mg on pod2 and pod 4 vs placebo on pod2 and pod4.

    Primary: VAS

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    End point title
    		 VAS [1]
    End point description
    End point type
    Primary
    End point timeframe
    Until postoperative day 14
    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: The median VAS for each group at measure point was compared with Mann Whitney U-test. no statistical analyses has been added in the result section, as only one p value can be reported.
    End point values
    		 High dose low dose
    Number of subjects analysed
    9
    9
    Units: VAS
    median (inter-quartile range (Q1-Q3))
        Day of surgery, evening rest
    4 (0 to 5)
    2.5 (1.5 to 3)
        day of surgery, evening swallow
    5 (1 to 7)
    3.25 (1 to 4)
        POD1, rest morning
    3 (0 to 5)
    2 (2 to 4)
        POD1, swallow morning
    5 (1 to 7)
    4 (3.5 to 5)
        POD1, rest evening
    3 (0 to 6)
    2 (2 to 4)
        POD1, swallow evening
    4 (2 to 8)
    4 (4 to 5)
        POD2, rest morning
    3 (1 to 5)
    2 (2 to 4)
        POD2, swallow morning
    5 (3 to 6)
    5 (4 to 6)
        POD2, rest evening
    3 (1 to 4)
    2.5 (2 to 6)
        POD2, swallow evening
    4 (3 to 4)
    5 (3 to 7)
        POD3, rest morning
    3 (1 to 5)
    4 (2 to 5)
        POD3, swallow morning
    4 (4 to 5)
    6 (3 to 7)
        POD3, rest evening
    3 (2 to 4)
    3.5 (2 to 5)
        POD3, swallow evening
    4 (4 to 5)
    6 (3 to 7)
        POD4, rest morning
    4 (2 to 7)
    3.5 (2 to 5)
        POD4, swallow morning
    5 (4 to 7)
    6 (4 to 7)
        POD4, rest evening
    4 (2 to 6)
    3 (2 to 6)
        POD4, swallow evening
    4 (3 to 7)
    6 (5 to 7)
        POD5, rest morning
    4 (2 to 7)
    3 (2 to 5)
        POD5, swallow morning
    5 (4 to 8.5)
    5 (4 to 7)
        POD5, rest evening
    4 (2 to 7)
    3 (2 to 6)
        POD5, swallow evening
    4 (3 to 7)
    6 (5 to 7)
        POD6, rest morning
    4 (3 to 7)
    4 (3 to 6)
        POD6, swallow morning
    6 (4 to 7)
    6 (4.5 to 7.75)
        POD6, rest evening
    4 (3 to 6)
    4 (3 to 7)
        POD6, swallow evening
    6 (4 to 7)
    6.5 (5 to 7)
        POD7, rest morning
    4 (3 to 7)
    4 (2 to 7)
        POD7, swallow morning
    5 (4 to 7)
    6 (4.5 to 8)
        POD7, rest evening
    4 (3 to 7)
    5 (3 to 7)
        POD7, swallow evening
    6 (4 to 8)
    6 (5 to 8)
        POD8, rest morning
    4 (4 to 6)
    6 (3 to 7)
        POD8, swallow morning
    6 (4 to 7)
    6.5 (6 to 7)
        POD8, rest evening
    4 (3 to 6)
    6 (3 to 7)
        POD8, swallow evening
    6 (4 to 7)
    7 (6 to 7)
        POD9, rest morning
    5 (3 to 8)
    5 (3.8 to 7)
        POD9, swallow morning
    6 (4 to 8)
    6.7 (5 to 8)
        POD9, rest evening
    5 (4 to 6)
    6 (3 to 7)
        POD9, swallow evening
    6 (5 to 6)
    7 (5 to 7)
        POD10, rest morning
    5 (2 to 6)
    4 (3 to 5)
        POD10, swallow morning
    6 (4 to 7)
    5 (4 to 6)
        POD10, rest evening
    4 (3 to 6)
    3 (2.5 to 7)
        POD10, swallow evening
    6 (4 to 6)
    4 (4 to 7)
        POD11, rest morning
    4 (3 to 5)
    4 (2 to 6.5)
        POD11, swallow morning
    5 (4 to 6)
    4 (3 to 7)
        POD11, rest evening
    3 (2 to 4)
    4 (3 to 7)
        POD11, swallow evening
    5 (3 to 5)
    5 (4 to 7)
        POD12, rest morning
    2 (2 to 4)
    3 (2.5 to 4.5)
        POD12, swallow morning
    4 (3 to 4)
    4 (3 to 5.5)
        POD12, rest evening
    3 (2 to 4)
    2 (2 to 4)
        POD12, swallow evening
    4 (3 to 4)
    3 (3 to 5)
        POD13, rest morning
    3 (2 to 3)
    3 (1 to 5)
        POD13, swallow morning
    3 (3 to 3)
    4 (3 to 5)
        POD13, rest evening
    2 (1.5 to 3)
    2 (1.5 to 4)
        POD13, swallow evening
    2 (2 to 3)
    3 (3 to 5)
        POD14, rest morning
    2 (1 to 2)
    1 (1 to 4)
        POD14, swallow morning
    2 (2 to 2)
    3 (2 to 5)
        POD14, rest evening
    1.5 (1 to 2)
    2 (1 to 4)
        POD14, swallow evening
    2 (2 to 2)
    3 (2 to 4.5)
    No statistical analyses for this end point

    Secondary: Length of stay

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    End point title
    		 Length of stay
    End point description
    End point type
    Secondary
    End point timeframe
    from day of surgery until discharge
    End point values
    		 High dose low dose
    Number of subjects analysed
    9
    9
    Units: day
        median (inter-quartile range (Q1-Q3))
    4 (4 to 4)
    4 (4 to 4)
    No statistical analyses for this end point

    Secondary: Rescue opioid use, during primary admission

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    End point title
    		 Rescue opioid use, during primary admission
    End point description
    End point type
    Secondary
    End point timeframe
    from day of surgery until discharge
    End point values
    		 High dose low dose
    Number of subjects analysed
    9
    9
    Units: mg
        median (inter-quartile range (Q1-Q3))
    15 (0 to 66)
    0 (0 to 70)
    No statistical analyses for this end point

    Secondary: rescue opioid use, day of surgery until postoperative day 14

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    End point title
    		 rescue opioid use, day of surgery until postoperative day 14
    End point description
    End point type
    Secondary
    End point timeframe
    from day of surgery until postoperative day 14
    End point values
    		 High dose low dose
    Number of subjects analysed
    9
    9
    Units: mg
        median (inter-quartile range (Q1-Q3))
    70 (30 to 270)
    22.5 (0 to 120)
    No statistical analyses for this end point

    Secondary: mortality

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    End point title
    		 mortality
    End point description
    End point type
    Secondary
    End point timeframe
    thirty day mortality
    End point values
    		 High dose low dose
    Number of subjects analysed
    9
    9
    Units: subjects
        yes
    0
    0
        no
    9
    9
    No statistical analyses for this end point

    Secondary: Postoperative hemorrhage

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    End point title
    		 Postoperative hemorrhage
    End point description
    End point type
    Secondary
    End point timeframe
    from day of surgery until followup
    End point values
    		 High dose low dose
    Number of subjects analysed
    9
    9
    Units: subjects
        yes
    0
    0
        no
    9
    9
    No statistical analyses for this end point

    Secondary: postoperative nausea and vomitting

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    End point title
    		 postoperative nausea and vomitting
    End point description
    End point type
    Secondary
    End point timeframe
    Postoperative day 1-14
    End point values
    		 High dose low dose
    Number of subjects analysed
    9
    9
    Units: subjects
        Day 1-4
    1
    2
        day 5-7
    2
    2
        day 8-14
    2
    2
    No statistical analyses for this end point

    Secondary: Postoperative infection

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    End point title
    		 Postoperative infection
    End point description
    End point type
    Secondary
    End point timeframe
    From day of surgery until follow-up
    End point values
    		 High dose low dose
    Number of subjects analysed
    9
    9
    Units: subjects
        no infection
    8
    6
        infection treated with oral antibiotics
    1
    2
        infection treated with intravenous antibiotics
    0
    1
    No statistical analyses for this end point

    Secondary: Blood glucose level

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    End point title
    		 Blood glucose level
    End point description
    End point type
    Secondary
    End point timeframe
    Postoperative day 2 and 4
    End point values
    		 High dose low dose
    Number of subjects analysed
    9
    9
    Units: mmol/L
    median (inter-quartile range (Q1-Q3))
        Postoperative day 2
    6.15 (5.25 to 6.75)
    5.10 (4.8 to 5.7)
        postoperative day 4
    5.2 (4.9 to 5.7)
    4.85 (4.7 to 5.55)
    No statistical analyses for this end point

    Secondary: Tracheotomy placement

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    End point title
    		 Tracheotomy placement
    End point description
    End point type
    Secondary
    End point timeframe
    Day of surgery until postoperative day 30
    End point values
    		 High dose low dose
    Number of subjects analysed
    9
    9
    Units: subjects
        yes
    0
    0
        no
    9
    9
    No statistical analyses for this end point

    Secondary: Unplanned readmission

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    End point title
    		 Unplanned readmission
    End point description
    End point type
    Secondary
    End point timeframe
    Thirty day unplanned readmission rate
    End point values
    		 High dose low dose
    Number of subjects analysed
    9
    9
    Units: Subjects
        yes
    0
    0
        no
    9
    9
    No statistical analyses for this end point

    Secondary: Naso gastic tube placement

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    End point title
    		 Naso gastic tube placement
    End point description
    End point type
    Secondary
    End point timeframe
    From day of surgery until removal
    End point values
    		 High dose low dose
    Number of subjects analysed
    9
    9
    Units: day
        median (inter-quartile range (Q1-Q3))
    1 (1 to 4)
    1 (1 to 2)
    No statistical analyses for this end point

    Secondary: Feeding tube re-insertion

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    End point title
    		 Feeding tube re-insertion
    End point description
    End point type
    Secondary
    End point timeframe
    thirty day feeding tube re-insertion rate
    End point values
    		 High dose low dose
    Number of subjects analysed
    9
    9
    Units: subjects
        yes
    0
    0
        no
    9
    9
    No statistical analyses for this end point

    Secondary: Days until oral dietary intake

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    End point title
    		 Days until oral dietary intake
    End point description
    End point type
    Secondary
    End point timeframe
    from day of surgery until oral dietary intake
    End point values
    		 High dose low dose
    Number of subjects analysed
    9
    9
    Units: day
        median (inter-quartile range (Q1-Q3))
    1 (1 to 1)
    1 (1 to 1)
    No statistical analyses for this end point

    Secondary: Patient reported Food consistency

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    End point title
    		 Patient reported Food consistency
    End point description
    Patient reported Food consistency
    End point type
    Secondary
    End point timeframe
    POD1 until POD 14
    End point values
    		 High dose low dose
    Number of subjects analysed
    9
    9
    Units: subjects
    9
    9
    Attachments
    		 Untitled (Filename: figure3.pdf)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    until 60 hours after last administration of study drug. SAE/SAR until postoperative day 14
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 none
    Dictionary version
    0
    Reporting groups
    Reporting group title
    ALL adverse events/reactions and SAE/SAR
    Reporting group description
    		 -

    Serious adverse events
    		 ALL adverse events/reactions and SAE/SAR
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 18 (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
    		 ALL adverse events/reactions and SAE/SAR
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 18 (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: There were no Adverse events or reactions or SAE/SAR in the cohort. The trial has a limited sample size, which can explain no adverse events

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Oct 2022
    Sample size changed from 34 in total to 18 patients in total

    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.
    All patients in the CUP group were HPV+.
    For support, Contact us.
    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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