EntropionNCT02916407
The Effect of Preoperative Ketamine on the Emergence Characteristics in Children Undergoing Entropion Surgery
A study testing Sevoflurane and Desflurane in people with Entropion, run by Inje University at 1 site in South Korea.
Trial summary
The investigators evaluate extubation time and recovery profiles in children undergoing entropion surgery. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Entropion
- What is being tested?
- Sevoflurane and Desflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2016to Nov 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- American society of anesthesiologist class 1 patients
- 3-6 years children undergoing entropion surgery
Who cannot join
- Do not agree with participate this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Preoperative Ketamine on the Emergence Characteristics After Desflurane or Sevoflurane Anesthesia in Children Undergoing Entropion Surgery
The investigators evaluate extubation time and recovery profiles in children undergoing entropion surgery.
Read the detailed description
This study will compare the extubation time and recovery profiles (degree of postoperative agitation and cough) between sevoflurane group and desflurane group. General anesthesia will maintained with sevoflurane 2-3vol% or desflurane 6-7vol%. After surgery, the investigators will measure the duration of extubation and recovery profiles between two groups.
- Conditions
- Entropion
- Being tested
- Sevoflurane, Desflurane
- Keywords
- Anesthesia, Agitation, Extubation
- Medical subject headings
- Entropion, Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Also called sevofrane
Intravenous ketamine will administrate to the patients for decreasing of separation anxiety of children.
General anesthesia will maintained with sevoflurane 2-3 vol%.
DesfluraneDrug
Also called suprane
Intravenous ketamine will administrate to the patients for decreasing of separation anxiety of children.
General anesthesia will maintained with desflurane 6-7vol%.
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane Group | Active comparator | The patients will maintained general anesthesia with sevoflurane. Receives: Drug: Sevoflurane |
| Desflurane Group | Experimental | The patients will maintained general anesthesia with desflurane. Receives: Drug: Desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extubation Time
compare the extubation time between sevoflurane and desflurane group
Measured: 30 minutes
Secondary outcomes (1)
Degree of Postoperative Agitation
Postoperative agitation will measure using Pediatric Anesthesia Emergence Delirium (PAED) scale. PAED scale is "(1) The child makes eye contact with the caregiver (2) The child's action are purposeful (3) The child is aware of his/her surrounding (4) The child is restless (5) The child is inconsolable." It scores 0-4, and total maximum score is 20.
PAED score > 12 was used to determine occurence of postoperative agitation.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for EntropionStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ki Hwa Lee, Inje University
- Investigators
- Ki Hwa Lee, M.D,, Principal investigator, Inje University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02916407
- Sponsor's protocol ID
- 2016-01
- Status last verified
- Apr 2019
- First submitted
- 1 Sep 2016
- Last updated
- 3 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Ketamine on the Emergence Characteristics After Desflurane or Sevoflurane Anesthesia in Children Undergoing Entropion Surgery
- ClinicalTrials.gov ID
- NCT02916407
- Acronym / sponsor ID
- 2016-01
- Conditions
- Entropion
- Keywords
- Anesthesia, Agitation, Extubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 27 Sep 2016 (estimated)
- Results
- Posted 3 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators evaluate extubation time and recovery profiles in children undergoing entropion surgery.
Detailed description
This study will compare the extubation time and recovery profiles (degree of postoperative agitation and cough) between sevoflurane group and desflurane group. General anesthesia will maintained with sevoflurane 2-3vol% or desflurane 6-7vol%. After surgery, the investigators will measure the duration of extubation and recovery profiles between two groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane Group | Active comparator | Drug: SevofluraneThe patients will maintained general anesthesia with sevoflurane. |
| Desflurane Group | Experimental | Drug: DesfluraneThe patients will maintained general anesthesia with desflurane. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- American society of anesthesiologist class 1 patients
- 3-6 years children undergoing entropion surgery
Key exclusion criteria (1 listed)
- Do not agree with participate this study
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 |
|---|---|---|
| SevofluraneAlso: sevofraneIntravenous ketamine will administrate to the patients for decreasing of separation anxiety of children. General anesthesia will maintained with sevoflurane 2-3 vol%. | Drug | Sevoflurane Group |
| DesfluraneAlso: supraneIntravenous ketamine will administrate to the patients for decreasing of separation anxiety of children. General anesthesia will maintained with desflurane 6-7vol%. | Drug | Desflurane Group |
Primary outcome
Extubation Time
Time frame: 30 minutes
compare the extubation time between sevoflurane and desflurane group
1 secondary outcome
Degree of Postoperative Agitation
Time frame: 30 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Ki Hwa Lee, M.D, principal investigator
Inje University
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 and Desflurane in people with Entropion, run by Inje University 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 2 inclusion and 1 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 3 May 2019. 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?
Yes. Results are posted in the registry (first posted 3 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Extubation Time (time frame: 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 3 May 2019.