NCT02470442

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 12, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

August 4, 2017

Status Verified

August 1, 2017

Enrollment Period

8 months

First QC Date

June 8, 2015

Last Update Submit

August 2, 2017

Conditions

Desflurane Anesthesia

Outcome Measures

Primary Outcomes (1)

  • respiratory adverse events

    participants will be followed for postoperative period, an expected average of 30 minutes.

Secondary Outcomes (1)

  • emergence agitation

    15 minutes after arrival on PACU

Study Arms (2)

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

Sevoflurane/DesfluraneDRUG

Anesthesia induced with sevoflurane and anesthetic maintenance with desflurane

Also known as: suprane
Sevoflurane/Desflurane
SevofluraneDRUG

Anesthesia induced with sevoflurane and anesthetic maintenance with sevoflurane

Sevoflurane

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul national university hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Interventions

SevofluraneDesflurane

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsEthyl Ethers

Study Officials

  • JinTae Kim, MD. PhD.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 8, 2015

First Posted

June 12, 2015

Study Start

June 1, 2015

Primary Completion

February 1, 2016

Study Completion

March 1, 2016

Last Updated

August 4, 2017

Record last verified: 2017-08

Locations

KR(1)