search
Back to results

Ventilatory Effect on Speed of Anesthesia Under Various Inhaled Anesthetics

Primary Purpose

Pharmacokinetics of Inhaled Anesthetics

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sevoflurane
Desflurane
Isoflurane
Sponsored by
DongGuk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pharmacokinetics of Inhaled Anesthetics focused on measuring Anesthetic induction, Desflurane, Isoflurane, Sevoflurane, Ventilation

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA PS I, II
  • Age: 20-60 years male and female
  • Elective schedule with minor surgery
  • BMI < 30

Exclusion Criteria:

  • Patients with pulmonary, cardiac, endocrinal, neuromuscular and neurological diseases or past history
  • Upper airway anomaly or deformity
  • ASA PS III or higher
  • Pregnant women
  • BMI >= 30

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Group A(Sevoflurane)

    Group B(Desflurane)

    Group C(Isoflurane)

    Arm Description

    Twelve patients will be enrolled in this group. They will be divided into subgroups with ventilatory settings. Each subgroup has 4 patients. A8: tidal volume(8 ml/kg) and respiratory rate(10 /min) A10: tidal volume(10 ml/kg) and respiratory rate(10 /min) A12: tidal volume(12 ml/kg) and respiratory rate(10 /min)

    Twelve patients will be enrolled in this group. They will be divided into subgroups with ventilatory settings. Each subgroup has 4 patients. A8: tidal volume(8 ml/kg) and respiratory rate(10 /min) A10: tidal volume(10 ml/kg) and respiratory rate(10 /min) A12: tidal volume(12 ml/kg) and respiratory rate(10 /min)

    Twelve patients will be enrolled in this group. They will be divided into subgroups with ventilatory settings. Each subgroup has 4 patients. A8: tidal volume(8 ml/kg) and respiratory rate(10 /min) A10: tidal volume(10 ml/kg) and respiratory rate(10 /min) A12: tidal volume(12 ml/kg) and respiratory rate(10 /min)

    Outcomes

    Primary Outcome Measures

    End-tidal concentrations of isoflurane, sevoflurane and desflurane, and BIS values with hypo-, normo-, hyperventilation
    The inspiratory, and end-tidal concentrations of volatile anesthetics, partial pressure of end-tidal carbon dioxide will be recorded from an S/5 Avance anesthetic workstation (Datex-Ohmeda) and an embedded monitor. BIS values are measured with a BIS monitor.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 28, 2010
    Last Updated
    August 9, 2012
    Sponsor
    DongGuk University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01171833
    Brief Title
    Ventilatory Effect on Speed of Anesthesia Under Various Inhaled Anesthetics
    Official Title
    Effect of Ventilation on Speed of Induction of Anesthesia in Desflurane, Sevoflurane, and Isoflurane
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2010 (undefined)
    Primary Completion Date
    October 2010 (Actual)
    Study Completion Date
    October 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    DongGuk University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Three groups of patients are going to have minor surgery under general anesthesia with inhaled anesthetics and different ventilatory setting (Tidal volume: 8, 10, 12 ml/kg, respiratory rate: 10/min each). Group A (Sevoflurane) will use sevoflurane, group B (Desflurane) will use desflurane, and group C (Isoflurane) will use isoflurane. It will be observed differences among the groups for ventilatory effects on speed of induction. Duration of this randomised controlled trial will be about 3 months. Estimated sample size will be 36 patients(12 in each group).
    Detailed Description
    No premedicant will be given. The anesthetic workstation and a circulatory circuit will be prefilled with 1.0 MAC of inhaled anesthetic that will be selected randomly. Group A (n=12): Sevoflurane 2.0 vol% Group B (n=12): Desflurane 6.0 vol% Group C (n=12): Isoflurane 1.2 vol% Each group has 3 subgroups according to the ventilatory setting that will also be randomly determined. Hypoventilation: tidal volume 8 ml/kg, respiratory rate 10 /min Normoventilation: tidal volume 10 ml/kg, respiratory rate 10 /min Hyperventilation: tidal volume 12 ml/kg, respiratory rate 10 /min Patients will be preoxygenated with 100% oxygen (5 L/min) for 5 minutes under pulse oximeter, EKG, and noninvasive blood pressure monitoring. Bispectral index (BIS) monitor will be applied. The induction of general anesthesia will start with propofol (2 mg/kg), rocuronium (0.8 mg/kg) and remifentanil infusion (0.1 mcg/kg/min). The size of a tracheal tube will be 7.5 mm (ID) for male, 7.0 mm (ID) for female. After intubation, anesthesia workstation will be connected to the tracheal tube. Ventilation will start, and that point will be time 0. During 720 seconds, inspiratory (PIgas) and end-tidal concentration of inhaled anesthetics (ETgas), end-tidal partial pressure of carbon dioxide, and BIS will be measured at time 0, 30, 60, 90, 120 ,150, 180, 240, 300, 360, 480, 600, and 720 seconds. Mean blood pressure and heart rate will also be recorded every 2 minutes. Fresh gas flow will be kept at 6 L/min with 100% oxygen. The fraction of ETgas/PIgas will be analyzed with nonlinear mixed effects modeling. Estimated sample size will be 36 patients (12 in each group, 4 in each ventilatory settings).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pharmacokinetics of Inhaled Anesthetics
    Keywords
    Anesthetic induction, Desflurane, Isoflurane, Sevoflurane, Ventilation

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    36 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A(Sevoflurane)
    Arm Type
    Experimental
    Arm Description
    Twelve patients will be enrolled in this group. They will be divided into subgroups with ventilatory settings. Each subgroup has 4 patients. A8: tidal volume(8 ml/kg) and respiratory rate(10 /min) A10: tidal volume(10 ml/kg) and respiratory rate(10 /min) A12: tidal volume(12 ml/kg) and respiratory rate(10 /min)
    Arm Title
    Group B(Desflurane)
    Arm Type
    Experimental
    Arm Description
    Twelve patients will be enrolled in this group. They will be divided into subgroups with ventilatory settings. Each subgroup has 4 patients. A8: tidal volume(8 ml/kg) and respiratory rate(10 /min) A10: tidal volume(10 ml/kg) and respiratory rate(10 /min) A12: tidal volume(12 ml/kg) and respiratory rate(10 /min)
    Arm Title
    Group C(Isoflurane)
    Arm Type
    Experimental
    Arm Description
    Twelve patients will be enrolled in this group. They will be divided into subgroups with ventilatory settings. Each subgroup has 4 patients. A8: tidal volume(8 ml/kg) and respiratory rate(10 /min) A10: tidal volume(10 ml/kg) and respiratory rate(10 /min) A12: tidal volume(12 ml/kg) and respiratory rate(10 /min)
    Intervention Type
    Drug
    Intervention Name(s)
    Sevoflurane
    Other Intervention Name(s)
    Sevorane
    Intervention Description
    2.0 vol% prefilled in a corrugated circuit.
    Intervention Type
    Drug
    Intervention Name(s)
    Desflurane
    Other Intervention Name(s)
    Suprane
    Intervention Description
    6.0 vol% prefilled in a corrugated circuit.
    Intervention Type
    Drug
    Intervention Name(s)
    Isoflurane
    Other Intervention Name(s)
    Aerane
    Intervention Description
    1.2 vol% prefilled in a corrugated circuit.
    Primary Outcome Measure Information:
    Title
    End-tidal concentrations of isoflurane, sevoflurane and desflurane, and BIS values with hypo-, normo-, hyperventilation
    Description
    The inspiratory, and end-tidal concentrations of volatile anesthetics, partial pressure of end-tidal carbon dioxide will be recorded from an S/5 Avance anesthetic workstation (Datex-Ohmeda) and an embedded monitor. BIS values are measured with a BIS monitor.
    Time Frame
    at 0, 30, 60, 90, 120, 180, 240, 300, 360, 480, 600, 720 sec after volatile gas starts

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ASA PS I, II Age: 20-60 years male and female Elective schedule with minor surgery BMI < 30 Exclusion Criteria: Patients with pulmonary, cardiac, endocrinal, neuromuscular and neurological diseases or past history Upper airway anomaly or deformity ASA PS III or higher Pregnant women BMI >= 30
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Junyong In, MD
    Organizational Affiliation
    Dept. of anesthesiology and pain medicine, Dongguk University Ilsan Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Ventilatory Effect on Speed of Anesthesia Under Various Inhaled Anesthetics

    We'll reach out to this number within 24 hrs