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Influence of Sevoflurane and Desflurane on Postoperative Sore Throat

Primary Purpose

Hip Arthroplasty

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sevoflurane
Desflurane
Sponsored by
Keimyung University Dongsan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hip Arthroplasty focused on measuring intubation, pharyngitis, remifentanil

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA I-III
  • Patients scheduled for general anesthesia with endotracheal intubation

Exclusion Criteria:

  • Difficult airway
  • Friable teeth
  • Rapid sequence induction
  • Recent sore throat
  • Recent upper respiratory infection
  • Asthma
  • Chronic obstructive pulmonary disease
  • Chronic cough
  • Arrhythmia
  • Coronary disease
  • Heart failure
  • Pregnancy
  • Allergy to sevoflurane
  • Allergy to desflurane
  • Fever after halogenated anesthetics
  • Jaundice after halogenated anesthetics
  • Malignant hyperthremia
  • Allergy to remifentanil
  • Friable teeth
  • History of head and neck surgery
  • Multiple intubation attempts
  • Regional anesthetic agents
  • Gastric tube
  • Dexamethasone
  • Severe hypovolemia

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Sevoflurane

    Desflurane

    Arm Description

    Outcomes

    Primary Outcome Measures

    Number of participants with postoperative sore throat

    Secondary Outcome Measures

    Number of participants with postoperative sore throat
    Number of participants with postoperative hoarseness
    Number of participants with postoperative cough
    Number of participants with postoperative nausea
    Number of participants with postoperative vomiting
    Number of participants with additional pain medication
    Visual analogue scale of postoperative pain
    Number of participants with shivering
    Requirements of analgesics

    Full Information

    First Posted
    August 21, 2017
    Last Updated
    August 21, 2017
    Sponsor
    Keimyung University Dongsan Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03259672
    Brief Title
    Influence of Sevoflurane and Desflurane on Postoperative Sore Throat
    Official Title
    Influence of Sevoflurane and Desflurane on Postoperative Sore Throat
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2017 (Anticipated)
    Primary Completion Date
    October 1, 2018 (Anticipated)
    Study Completion Date
    November 1, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Keimyung University Dongsan Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This investigation is planned to compare the incidence and severity of postoperative sore throat according to the use of sevoflurane or desflurane.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hip Arthroplasty
    Keywords
    intubation, pharyngitis, remifentanil

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Sevoflurane
    Arm Type
    Active Comparator
    Arm Title
    Desflurane
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Sevoflurane
    Intervention Description
    Sevoflurane was used as a maintenance anesthetic agent.
    Intervention Type
    Drug
    Intervention Name(s)
    Desflurane
    Intervention Description
    Desflurane was used as a maintenance anesthetic agent.
    Primary Outcome Measure Information:
    Title
    Number of participants with postoperative sore throat
    Time Frame
    At 24 hr
    Secondary Outcome Measure Information:
    Title
    Number of participants with postoperative sore throat
    Time Frame
    At 0, 2, 4 and 24 hr
    Title
    Number of participants with postoperative hoarseness
    Time Frame
    At 0, 2, 4 and 24 hr
    Title
    Number of participants with postoperative cough
    Time Frame
    At 0, 2, 4 and 24 hr
    Title
    Number of participants with postoperative nausea
    Time Frame
    At 0, 2, 4 and 24 hr
    Title
    Number of participants with postoperative vomiting
    Time Frame
    At 0, 2, 4 and 24 hr
    Title
    Number of participants with additional pain medication
    Time Frame
    At 0, 2, 4 and 24 hr
    Title
    Visual analogue scale of postoperative pain
    Time Frame
    At 0, 2, 4 and 24 hr
    Title
    Number of participants with shivering
    Time Frame
    At 0, 2, 4 and 24 hr
    Title
    Requirements of analgesics
    Time Frame
    At 0, 2, 4 and 24 hr

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ASA I-III Patients scheduled for general anesthesia with endotracheal intubation Exclusion Criteria: Difficult airway Friable teeth Rapid sequence induction Recent sore throat Recent upper respiratory infection Asthma Chronic obstructive pulmonary disease Chronic cough Arrhythmia Coronary disease Heart failure Pregnancy Allergy to sevoflurane Allergy to desflurane Fever after halogenated anesthetics Jaundice after halogenated anesthetics Malignant hyperthremia Allergy to remifentanil Friable teeth History of head and neck surgery Multiple intubation attempts Regional anesthetic agents Gastric tube Dexamethasone Severe hypovolemia

    12. IPD Sharing Statement

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    Influence of Sevoflurane and Desflurane on Postoperative Sore Throat

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