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Influence of Sevoflurane and Desflurane on Postoperative Sore Throat

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ClinicalTrials.gov Identifier: NCT03259672
Recruitment Status : Unknown
Verified August 2017 by Hyun-Chang Kim, Keimyung University Dongsan Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : August 24, 2017
Last Update Posted : August 24, 2017
Sponsor:
Information provided by (Responsible Party):
Hyun-Chang Kim, Keimyung University Dongsan Medical Center

Tracking Information
First Submitted Date  ICMJE August 21, 2017
First Posted Date  ICMJE August 24, 2017
Last Update Posted Date August 24, 2017
Estimated Study Start Date  ICMJE October 1, 2017
Estimated Primary Completion Date October 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2017)
Number of participants with postoperative sore throat [ Time Frame: At 24 hr ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2017)
  • Number of participants with postoperative sore throat [ Time Frame: At 0, 2, 4 and 24 hr ]
  • Number of participants with postoperative hoarseness [ Time Frame: At 0, 2, 4 and 24 hr ]
  • Number of participants with postoperative cough [ Time Frame: At 0, 2, 4 and 24 hr ]
  • Number of participants with postoperative nausea [ Time Frame: At 0, 2, 4 and 24 hr ]
  • Number of participants with postoperative vomiting [ Time Frame: At 0, 2, 4 and 24 hr ]
  • Number of participants with additional pain medication [ Time Frame: At 0, 2, 4 and 24 hr ]
  • Visual analogue scale of postoperative pain [ Time Frame: At 0, 2, 4 and 24 hr ]
  • Number of participants with shivering [ Time Frame: At 0, 2, 4 and 24 hr ]
  • Requirements of analgesics [ Time Frame: At 0, 2, 4 and 24 hr ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Influence of Sevoflurane and Desflurane on Postoperative Sore Throat
Official Title  ICMJE Influence of Sevoflurane and Desflurane on Postoperative Sore Throat
Brief Summary This investigation is planned to compare the incidence and severity of postoperative sore throat according to the use of sevoflurane or desflurane.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Hip Arthroplasty
Intervention  ICMJE
  • Drug: Sevoflurane
    Sevoflurane was used as a maintenance anesthetic agent.
  • Drug: Desflurane
    Desflurane was used as a maintenance anesthetic agent.
Study Arms  ICMJE
  • Active Comparator: Sevoflurane
    Intervention: Drug: Sevoflurane
  • Experimental: Desflurane
    Intervention: Drug: Desflurane
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 21, 2017)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 1, 2018
Estimated Primary Completion Date October 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03259672
Other Study ID Numbers  ICMJE SevoDesPOST
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hyun-Chang Kim, Keimyung University Dongsan Medical Center
Study Sponsor  ICMJE Keimyung University Dongsan Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Keimyung University Dongsan Medical Center
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP