Desflurane in Children With Laryngeal Mask Airway | NCT02470442

Studies
Desflurane in Children With Laryngeal Mask Airway

NCT02470442

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Aug 4, 2017Actual

Enrollment

200Actual

Phase

Not Applicable

Conditions

Desflurane Anesthesia

Interventions

Sevoflurane/Desflurane
Sevoflurane

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2015

Primary Completion Date

Feb 2016Actual

Completion Date

Mar 2016Actual

First Submitted Date

Jun 8, 2015

First Submission Date that Met QC Criteria

Jun 9, 2015

First Posted Date

Jun 12, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 2, 2017

Last Update Posted Date

Aug 4, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sevoflurane/Desflurane	Experimental	After induction of general anesthesia with sevoflurane, anesthesia was maintained with desflurane.	Drug: Sevoflurane/Desflurane
Sevoflurane	Experimental	the anesthetic induction and maintenance with sevoflurane.	Drug: Sevoflurane

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sevoflurane/Desflurane	Drug	Anesthesia induced with sevoflurane and anesthetic maintenance with desflurane	Sevoflurane/Desflurane

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
emergence agitation		15 minutes after arrival on PACU

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

6 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
JinTae Kim, MD. PhD.	Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul national university hospital		Seoul		110-744	South Korea

Intervention Browse Module

MeSH Terms

ID	Term
D000077149	Sevoflurane
D000077335	Desflurane

Ancestor Terms

ID	Term
D008738	Methyl Ethers
D004987	Ethers
D009930	Organic Chemicals
D006845	Hydrocarbons, Fluorinated

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Browse Branches

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