Desflurane AnesthesiaNCT02470442
Desflurane in Children With Laryngeal Mask Airway
A study testing Sevoflurane/Desflurane and Sevoflurane in people with Desflurane Anesthesia, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Desflurane Anesthesia
- What is being tested?
- Sevoflurane/Desflurane and Sevoflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2015to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- scheduled for elective surgery under general anesthesia with laryngeal mask airway
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Desflurane Anesthesia
- Being tested
- Sevoflurane/Desflurane, Sevoflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sevoflurane/DesfluraneDrug
Also called suprane
Anesthesia induced with sevoflurane and anesthetic maintenance with desflurane
SevofluraneDrug
Anesthesia induced with sevoflurane and anesthetic maintenance with sevoflurane
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane/Desflurane | Experimental | After induction of general anesthesia with sevoflurane, anesthesia was maintained with desflurane. Receives: Drug: Sevoflurane/Desflurane |
| Sevoflurane | Experimental | the anesthetic induction and maintenance with sevoflurane. Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
respiratory adverse events
Measured: participants will be followed for postoperative period, an expected average of 30 minutes.
Secondary outcomes (1)
emergence agitation
Measured: 15 minutes after arrival on PACU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionFeb 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Desflurane AnesthesiaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
- Investigators
- JinTae Kim, MD. PhD., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02470442
- Sponsor's protocol ID
- H-1504-116-668
- Status last verified
- Aug 2017
- First submitted
- 8 Jun 2015
- Last updated
- 4 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sevoflurane Vs. Sevoflurane-desflurane Anesthesia in Children With Laryngeal Mask Airways; Difference in Respiratory Event, Recovery Time and Emergence Agitation
- ClinicalTrials.gov ID
- NCT02470442
- Acronym / sponsor ID
- H-1504-116-668
- Conditions
- Desflurane Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 12 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane/Desflurane | Experimental | Drug: Sevoflurane/DesfluraneAfter induction of general anesthesia with sevoflurane, anesthesia was maintained with desflurane. |
| Sevoflurane | Experimental | Drug: Sevofluranethe anesthetic induction and maintenance with sevoflurane. |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- scheduled for elective surgery under general anesthesia with laryngeal mask airway
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sevoflurane/DesfluraneAlso: supraneAnesthesia induced with sevoflurane and anesthetic maintenance with desflurane | Drug | Sevoflurane/Desflurane |
| SevofluraneAnesthesia induced with sevoflurane and anesthetic maintenance with sevoflurane | Drug | Sevoflurane |
Primary outcome
respiratory adverse events
Time frame: participants will be followed for postoperative period, an expected average of 30 minutes.
1 secondary outcome
emergence agitation
Time frame: 15 minutes after arrival on PACU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2017.
Related trials for Desflurane Anesthesia
Not yet recruitingPhase 4
Swap Anesthetic Versus Continuous Desflurane in Adults Undergoing Bariatric Surgery
Obesity, Bariatric Surgery
Recruiting
Evaluation of the Stress Response in Anesthesia Use Inhalation Anesthetic (Desflurane) Versus TIVA for Bariatric Surgery
Opioid Use, Bariatric Surgery Candidate
RecruitingPhase 4
Anesthesia and Non-small Cell Lung Cancer Recurrence
Non-small Cell Lung Cancer, Surgery
Not yet recruitingObservational study
Comparison of the Effects of Desflurane-Remifentanyl and Propofol-Remifentanyl Anesthesia on Intraoperative Cerebral Oxygenation in Patients Undergoing Laparoscopic Cholecystectomy
ıntraoperative Cerebral Oxygenation, Cerebral Oxygenation Monitoring
Not yet recruiting
Comparison of Sevoflurane and Desflurane on ANI in Patients Undergoing General Anesthesia: a Prospective Randomized Controlled Study
General Anesthesia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JinTae Kim, MD. PhD. principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sevoflurane/Desflurane and Sevoflurane in people with Desflurane Anesthesia, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
respiratory adverse events (time frame: participants will be followed for postoperative period, an expected average of 30 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2017.