Emergence AgitationNCT03807011
Emergence Agitation in Pediatric Strabismus Surgery
A study testing fentanyl group and remifentanil group in people with Emergence Agitation, run by Yeungnam University College of Medicine at 2 sites in South Korea.
Trial summary
This study was performed to assess the effects of continuous remifentanil infusion and single bolus administration of fentanyl on the incidence of emergence agitation in pediatrics undergoing strabismus surgery. Read more about this study
- Who is it for?
- Ages 2 to 8 years
- Conditions the study is for
- Emergence Agitation
- What is being tested?
- fentanyl group and remifentanil group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 7 Jul 2017to 5 Oct 2018
- 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 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- patients undergoing elective subumbilical surgery,
- physical status was American Society of Anesthesiologists (ASA) class 1 or 2
Who cannot join
- history of airway problem,
- upper respiratory tract infection within 2 weeks,
- developmental delay,
- neurological or psychological disease,
- history of allergy to the drugs in our protocol were excluded in this study.
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Eun kyung Choi
Daegu, Korea (the Republic Of), 41944
Yeungnam University Hospital
Daegu, Nam-gu, Daegu, 42415
About this study
Official title: The Effects of Remifentanil and Fentanyl on Emergence Agitation in Pediatric Strabismus Surgery
This study was performed to assess the effects of continuous remifentanil infusion and single bolus administration of fentanyl on the incidence of emergence agitation in pediatrics undergoing strabismus surgery.
- Conditions
- Emergence Agitation
- Being tested
- fentanyl group, remifentanil group
- Keywords
- Emergence Agitation, fentanyl, remifentanil, children
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fentanyl groupDrug
fentanyl 2 μg/kg
remifentanil groupDrug
remifentanil 0.2 μg/kg/min
| Study group | Role | What they receive |
|---|---|---|
| fentanyl | Active comparator | A bolus dose of fentanyl 2 μg/kg was administered intravenously at anesthetic induction Receives: Drug: fentanyl group |
| remifentanil | Active comparator | Remifentanil was continuously infused at a rate of 0.2 μg/kg/min from anesthetic induction to the end of surgery Receives: Drug: remifentanil group |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of postoperative agitation
0=none; 1=occur
Measured: 5 minutes in the recovery room
incidence of postoperative agitation
0=none; 1=occur
Measured: 30 minutes in the recovery room
severity of postoperative agitation
Four-point agitation scale (0=calm; 1=not calm but could easily become calmed; 3=not easily calmed, moderately agitated and restless; 4=combative, excited, or disoriented)
Measured: 5 minutes in the recovery room
severity of postoperative agitation
Four-point agitation scale (0=calm; 1=not calm but could easily become calmed; 3=not easily calmed, moderately agitated and restless; 4=combative, excited, or disoriented)
Measured: 30 minutes in the recovery room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start7 Jul 2017
- Primary completion5 Oct 2018
- Study completion5 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergence AgitationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeungnam University College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eun Kyung Choi, Yeungnam University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03807011
- Sponsor's protocol ID
- YUMC 2017-04-071
- Status last verified
- Jan 2019
- First submitted
- 14 Jan 2019
- Last updated
- 23 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Remifentanil and Fentanyl on Emergence Agitation in Pediatric Strabismus Surgery
- ClinicalTrials.gov ID
- NCT03807011
- Acronym / sponsor ID
- YUMC 2017-04-071
- Conditions
- Emergence Agitation
- Keywords
- Emergence Agitation, fentanyl, remifentanil, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Yeungnam University College of MedicineUniversity, hospital or other
- Study start
- 7 Jul 2017 (actual)
- Primary completion
- 5 Oct 2018 (actual)
- Study completion
- 5 Oct 2018 (actual)
- First posted
- 16 Jan 2019 (actual)
- 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.
This study was performed to assess the effects of continuous remifentanil infusion and single bolus administration of fentanyl on the incidence of emergence agitation in pediatrics undergoing strabismus surgery.
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 |
|---|---|---|
| fentanyl | Active comparator | Drug: fentanyl groupA bolus dose of fentanyl 2 μg/kg was administered intravenously at anesthetic induction |
| remifentanil | Active comparator | Drug: remifentanil groupRemifentanil was continuously infused at a rate of 0.2 μg/kg/min from anesthetic induction to the end of surgery |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- patients undergoing elective subumbilical surgery,
- physical status was American Society of Anesthesiologists (ASA) class 1 or 2
Key exclusion criteria (5 listed)
- history of airway problem,
- upper respiratory tract infection within 2 weeks,
- developmental delay,
- neurological or psychological disease,
- history of allergy to the drugs in our protocol were excluded in 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 |
|---|---|---|
| fentanyl groupfentanyl 2 μg/kg | Drug | fentanyl |
| remifentanil groupremifentanil 0.2 μg/kg/min | Drug | remifentanil |
Primary outcome
incidence of postoperative agitation
Time frame: 5 minutes in the recovery room
0=none; 1=occur
incidence of postoperative agitation
Time frame: 30 minutes in the recovery room
0=none; 1=occur
severity of postoperative agitation
Time frame: 5 minutes in the recovery room
Four-point agitation scale (0=calm; 1=not calm but could easily become calmed; 3=not easily calmed, moderately agitated and restless; 4=combative, excited, or disoriented)
severity of postoperative agitation
Time frame: 30 minutes in the recovery room
Four-point agitation scale (0=calm; 1=not calm but could easily become calmed; 3=not easily calmed, moderately agitated and restless; 4=combative, excited, or disoriented)
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 23 Jan 2019.
Related trials for Emergence Agitation
Recruiting
Low Pneumoperitoneum Pressure for Delirium Prevention in Elderly Laparoscopy
Postoperative Delirium (POD), Intracranial Hypertension
Recruiting
The Effect of Remimazolam Tosylate on the Incidence of Postoperative Delirium in Older Patients Undergoing Cardiac Surgery: A Prospective Randomized Controlled Trial
Delirium - Postoperative
RecruitingPhase 4
Acetaminophen-Mannitol Injection and Postoperative Delirium
Postoperative Delirium
Not yet recruitingPhase 4
Effects of Remimazolam on Postoperative Cognitive Dysfunction and Neuroinflammatory Biomarkers in Patients Undergoing Aortic Arch Surgery
Aortic Aneurysm of the Proximal Arch, Aortic Aneurysms Arch
Not yet recruitingObservational study
Sugammadex Timing and Recovery Profile in Pediatric Adenotonsillectomy
Neuromuscular Blockade, Delayed Emergence From 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fentanyl group and remifentanil group in people with Emergence Agitation, run by Yeungnam University College of Medicine at 2 sites 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 5 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 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
incidence of postoperative agitation (time frame: 5 minutes in the recovery room). The study lists 4 primary outcomes in all. 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 23 Jan 2019.