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NCT02740127 · BASELINE

Baseline characteristics

Evaluate Use of Caudal Nerve Blocks in Adult Penile Prosthesis · Source last updated 2022-01-24

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

denoms
  1. counts
    1. group Id
      BG000
      value
      24
    2. group Id
      BG001
      value
      28
    3. group Id
      BG002
      value
      52
    units
    Participants
groups
  1. description
    If the patient is randomized to Group I, the patient will receive general anesthesia using Propofol titrated for induction. The airway will be secured thereafter. The caudal block will be performed as a bolus injection into the caudal canal in the OR by the attending anesthesiologist using 1% Ropivacaine (max 5mg/kg) + 1:400,000 Epinephrine + Decadron 10mg + Clonidine 100mcg. Patients will be continuously monitored by ASA guidelines. Anesthesia will be maintained with Sevoflurane 1.3-2.5% or Desflurane 2.5-8.5%, oxygen, air, nitrous oxide and Fentanyl as needed. At the completion of surgery, reversal of muscle relaxant with Glycopyrrolate 0.2mg IV for each 1mg IV of Neostigmine (max 5mg) will be given as indicated.
    id
    BG000
    title
    General Anesthesia and Caudal Nerve Block
  2. description
    Patients in Group II will receive general anesthesia using Propofol titrated for induction. The airway will be secured thereafter. Anesthesia will be maintained with Sevoflurane 1.3-2.5% or Desflurane 2.5-8.5%, oxygen, air, nitrous oxide and fentanyl as needed. At the completion of surgery, reversal of muscle relaxant with Glycopyrrolate 0.2mg IV for each 1mg IV of neostigmine (max 5mg) will be given as indicated.
    id
    BG001
    title
    General Anesthesia Only
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          20
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          32
        title
        >=65 years
      denoms
      1. counts
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          52
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          52
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          52
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG002
          value
          0
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Race and Ethnicity were not collected from any participant.
    title
    Race and Ethnicity Not Collected
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          52
      denoms
      1. counts
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          52
        units
        Participants
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      24
    2. group Id
      BG001
      value
      28
    3. group Id
      BG002
      value
      52
    units
    Participants
groups
  1. description
    If the patient is randomized to Group I, the patient will receive general anesthesia using Propofol titrated for induction. The airway will be secured thereafter. The caudal block will be performed as a bolus injection into the caudal canal in the OR by the attending anesthesiologist using 1% Ropivacaine (max 5mg/kg) + 1:400,000 Epinephrine + Decadron 10mg + Clonidine 100mcg. Patients will be continuously monitored by ASA guidelines. Anesthesia will be maintained with Sevoflurane 1.3-2.5% or Desflurane 2.5-8.5%, oxygen, air, nitrous oxide and Fentanyl as needed. At the completion of surgery, reversal of muscle relaxant with Glycopyrrolate 0.2mg IV for each 1mg IV of Neostigmine (max 5mg) will be given as indicated.
    id
    BG000
    title
    General Anesthesia and Caudal Nerve Block
  2. description
    Patients in Group II will receive general anesthesia using Propofol titrated for induction. The airway will be secured thereafter. Anesthesia will be maintained with Sevoflurane 1.3-2.5% or Desflurane 2.5-8.5%, oxygen, air, nitrous oxide and fentanyl as needed. At the completion of surgery, reversal of muscle relaxant with Glycopyrrolate 0.2mg IV for each 1mg IV of neostigmine (max 5mg) will be given as indicated.
    id
    BG001
    title
    General Anesthesia Only
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          20
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          32
        title
        >=65 years
      denoms
      1. counts
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          52
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          52
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          52
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG002
          value
          0
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Race and Ethnicity were not collected from any participant.
    title
    Race and Ethnicity Not Collected
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          52
      denoms
      1. counts
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          52
        units
        Participants
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice