Desflurane in Children With Laryngeal Mask Airway

August 2, 2017 updated by: Jin-Tae Kim, Seoul National University Hospital

Sevoflurane Vs. Sevoflurane-desflurane Anesthesia in Children With Laryngeal Mask Airways; Difference in Respiratory Event, Recovery Time and Emergence Agitation

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • suprane
Experimental: Sevoflurane
the anesthetic induction and maintenance with sevoflurane.
Drug: Sevoflurane
Anesthesia induced with sevoflurane and anesthetic maintenance with sevoflurane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
respiratory adverse events
Time Frame: participants will be followed for postoperative period, an expected average of 30 minutes.
participants will be followed for postoperative period, an expected average of 30 minutes.

Secondary Outcome Measures

Outcome Measure
Time Frame
emergence agitation
Time Frame: 15 minutes after arrival on PACU
15 minutes after arrival on PACU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: JinTae Kim, MD. PhD., Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

June 8, 2015

First Submitted That Met QC Criteria

June 9, 2015

First Posted (Estimate)

June 12, 2015

Study Record Updates

Last Update Posted (Actual)

August 4, 2017

Last Update Submitted That Met QC Criteria

August 2, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-1504-116-668

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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