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Desflurane in Children With Laryngeal Mask Airway

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ClinicalTrials.gov Identifier: NCT02470442
Recruitment Status : Completed
First Posted : June 12, 2015
Last Update Posted : August 4, 2017
Sponsor:
Information provided by (Responsible Party):
Jin-Tae Kim, Seoul National University Hospital

Brief Summary:
The purpose of this study is to characterize the airway responses to desflurane during maintenance of and emergence from anesthesia in children whose airways were supported with laryngeal mask airways (LMAs).

Condition or disease Intervention/treatment Phase
Desflurane Anesthesia Drug: Sevoflurane/Desflurane Drug: Sevoflurane Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Sevoflurane Vs. Sevoflurane-desflurane Anesthesia in Children With Laryngeal Mask Airways; Difference in Respiratory Event, Recovery Time and Emergence Agitation
Study Start Date : June 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sevoflurane/Desflurane
After induction of general anesthesia with sevoflurane, anesthesia was maintained with desflurane.
Drug: Sevoflurane/Desflurane
Anesthesia induced with sevoflurane and anesthetic maintenance with desflurane
Other Name: suprane

Experimental: Sevoflurane
the anesthetic induction and maintenance with sevoflurane.
Drug: Sevoflurane
Anesthesia induced with sevoflurane and anesthetic maintenance with sevoflurane




Primary Outcome Measures :
  1. respiratory adverse events [ Time Frame: participants will be followed for postoperative period, an expected average of 30 minutes. ]

Secondary Outcome Measures :
  1. emergence agitation [ Time Frame: 15 minutes after arrival on PACU ]


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Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • scheduled for elective surgery under general anesthesia with laryngeal mask airway

Exclusion Criteria:

  • history of reactive airways disease with an acute exacerbation within the past 2 weeks
  • if wheezing or an active upper respiratory infection was present on the day of surgery
  • if there was a history of malignant hyperthermia
  • a history of moderate-to-severe hepatic dysfunction following anesthesia with desflurane not otherwise explained.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02470442


Locations
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Korea, Republic of
Seoul national university hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: JinTae Kim, MD. PhD. Seoul National University Hospital

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Responsible Party: Jin-Tae Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02470442     History of Changes
Other Study ID Numbers: H-1504-116-668
First Posted: June 12, 2015    Key Record Dates
Last Update Posted: August 4, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
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Anesthetics
Sevoflurane
Desflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General