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NCT02926573 · FLOW

Participant flow

Perioperative Gabapentin Use In Head And Neck Mucosal Surgery Patients · Source last updated 2018-08-08

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Gabapentin liquid by mouth or per Tube 300mg twice a day
    id
    FG000
    title
    Gabapentin
  2. description
    Placebo liquid by mouth or Per Tube twice a day
    id
    FG001
    title
    Placebo
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Nausea
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      type
      Remain intubated
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        1
      type
      Change in surgery plan
    4. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        1
      type
      Change to outpatient status
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      Return to operating room
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Delirium
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        55
      2. group Id
        FG001
        num Subjects
        55
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        44
      2. group Id
        FG001
        num Subjects
        46
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        9
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
13 participants were enrolled but withdrew prior to study participation with no medication given. 8 participants withdrew due to patient preference and 5 withdrew due to cancellation of surgery.
recruitment Details
The study opened to participant enrollment on 06/24/2016 and closed to participant enrollment on 06/30/2017.
Complete source fields
groups
  1. description
    Gabapentin liquid by mouth or per Tube 300mg twice a day
    id
    FG000
    title
    Gabapentin
  2. description
    Placebo liquid by mouth or Per Tube twice a day
    id
    FG001
    title
    Placebo
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Nausea
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      type
      Remain intubated
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        1
      type
      Change in surgery plan
    4. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        1
      type
      Change to outpatient status
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      Return to operating room
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Delirium
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        55
      2. group Id
        FG001
        num Subjects
        55
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        44
      2. group Id
        FG001
        num Subjects
        46
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        9
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
13 participants were enrolled but withdrew prior to study participation with no medication given. 8 participants withdrew due to patient preference and 5 withdrew due to cancellation of surgery.
recruitment Details
The study opened to participant enrollment on 06/24/2016 and closed to participant enrollment on 06/30/2017.

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Preserved source evidence · Not medical advice