Emergence AgitationNCT01506622
Comparison Between Propofol and Fentanyl for Prevention of Emergence Agitation in Children After Sevoflurane Anesthesia
A study testing Administration of propofol, Administration of fentanyl and Administration of saline in people with Emergence Agitation, run by Yonsei University at 1 site in South Korea.
Trial summary
The occurrence of emergence agitation (EA) in pediatric patients who have received sevoflurane anesthesia is a common postoperative problem. The prevalence of EA varies between 10% to 80% depending on the scoring system for evaluation and the anesthetic technique used. Read more about this study
- Who is it for?
- Ages 18 to 72 months
- Conditions the study is for
- Emergence Agitation
- What is being tested?
- Administration of propofol, Administration of fentanyl and Administration of saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2011to Dec 2011
- 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 18 to 72 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- American Society of Anesthesiologists I or II,
- 18-72 months of age,
- scheduled for ambulatory inguinal hernia repair undergoing general sevoflurane anesthesia
Who cannot join
- developmental delay
- psychological and neurologic disorder
- sedatives medication
- an abnormal airway
- reactive airway disease
- extreme agitation and uncooperation
- previous history of anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
The occurrence of emergence agitation (EA) in pediatric patients who have received sevoflurane anesthesia is a common postoperative problem. The prevalence of EA varies between 10% to 80% depending on the scoring system for evaluation and the anesthetic technique used.
Many authors reported various strategies such as use of sedative premedication, change of maintenance technique of anesthesia, or pharmacological agents administered at the end of anesthesia to reduce the incidence and severity of EA, and to allow a smooth emergence from sevoflurane anesthesia. Among these strategies, the use of pharmacological agents at the end of anesthesia is not affected by anesthetic duration, and may not prolong recovery duration of anesthesia excessively when these agents are administered as subhypnotic or small dose. The typical agents that can be administered in this way are propofol and fentanyl.
Read more
Previous studies demonstrated that the use of either propofol or fentanyl at the end of anesthesia could reduce the incidence of EA.
The purpose of this study is to compare the preventive effect on EA and the characteristics of anesthesia recovery between propofol and fentanyl administered at the end of sevoflurane anesthesia.
- Conditions
- Emergence Agitation
- Being tested
- Administration of propofol, Administration of fentanyl, Administration of saline
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of propofolDrug
Propofol 1 mg/kg will be administered to propofol group at the end of anesthesia.
Administration of fentanylDrug
Fentanyl 1 mcg/kg will be administered to fentanyl group at the end of anesthesia.
Administration of salineDrug
Saline will be administered to control group at the end of anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Propofol group | Active comparator | intravenous administration of propofol 1 mg/kg at the end of anesthesia Receives: Drug: Administration of propofol |
| Fentanyl group | Active comparator | intravenous administration of fentanyl 1 mcg/kg at the end of anesthesia Receives: Drug: Administration of fentanyl |
| Control group | Active comparator | intravenous administration of saline at the end of anesthesia Receives: Drug: Administration of saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of emergence agitation
The investigator will evaluate the incidence and extent of emergence agitation of participants, according to Aono's scale, the 5-step Emergence Agitation (EA) scale. Also, the Pediatric Anesthesia Emergence Delirium (PAED) scale will be used to assess emergence agitation. Aono's scale scores ≥3, 5-step (EA) scale ≥4 or PAED scale scores ≥10 will be considered as presence of emergence agitation
Measured: Participants will be followed for the duration of postanesthesia care unit (PACU) stay, an expected average of one hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2012 (estimated)
- Study startJan 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emergence AgitationStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01506622
- Sponsor's protocol ID
- 4-2010-0536
- Status last verified
- Jul 2015
- First submitted
- 25 Dec 2011
- Last updated
- 16 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chen J, Li W, Hu X, Wang D. Emergence agitation after cataract surgery in children: a comparison of midazolam, propofol and ketamine. Paediatr Anaesth. 2010 Sep;20(9):873-9. doi: 10.1111/j.1460-9592.2010.03375.x.
PubMed 20716081
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Propofol and Fentanyl for Prevention of Emergence Agitation in Children After Sevoflurane Anesthesia
- ClinicalTrials.gov ID
- NCT01506622
- Acronym / sponsor ID
- 4-2010-0536
- Conditions
- Emergence Agitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 10 Jan 2012 (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 occurrence of emergence agitation (EA) in pediatric patients who have received sevoflurane anesthesia is a common postoperative problem. The prevalence of EA varies between 10% to 80% depending on the scoring system for evaluation and the anesthetic technique used.
Many authors reported various strategies such as use of sedative premedication, change of maintenance technique of anesthesia, or pharmacological agents administered at the end of anesthesia to reduce the incidence and severity of EA, and to allow a smooth emergence from sevoflurane anesthesia. Among these strategies, the use of pharmacological agents at the end of anesthesia is not affected by anesthetic duration, and may not prolong recovery duration of anesthesia excessively when these agents are administered as subhypnotic or small dose. The typical agents that can be administered in this way are propofol and fentanyl.
Previous studies demonstrated that the use of either propofol or fentanyl at the end of anesthesia could reduce the incidence of EA.
The purpose of this study is to compare the preventive effect on EA and the characteristics of anesthesia recovery between propofol and fentanyl administered at the end of sevoflurane anesthesia.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Propofol group | Active comparator | Drug: Administration of propofolintravenous administration of propofol 1 mg/kg at the end of anesthesia |
| Fentanyl group | Active comparator | Drug: Administration of fentanylintravenous administration of fentanyl 1 mcg/kg at the end of anesthesia |
| Control group | Active comparator | Drug: Administration of salineintravenous administration of saline at the end of anesthesia |
Who may qualify
- Ages
- 18 to 72 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists I or II,
- 18-72 months of age,
- scheduled for ambulatory inguinal hernia repair undergoing general sevoflurane anesthesia
Key exclusion criteria (7 listed)
- developmental delay
- psychological and neurologic disorder
- sedatives medication
- an abnormal airway
- reactive airway disease
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 |
|---|---|---|
| Administration of propofolPropofol 1 mg/kg will be administered to propofol group at the end of anesthesia. | Drug | Propofol group |
| Administration of fentanylFentanyl 1 mcg/kg will be administered to fentanyl group at the end of anesthesia. | Drug | Fentanyl group |
| Administration of salineSaline will be administered to control group at the end of anesthesia. | Drug | Control group |
Primary outcome
The incidence of emergence agitation
Time frame: Participants will be followed for the duration of postanesthesia care unit (PACU) stay, an expected average of one hour.
The investigator will evaluate the incidence and extent of emergence agitation of participants, according to Aono's scale, the 5-step Emergence Agitation (EA) scale. Also, the Pediatric Anesthesia Emergence Delirium (PAED) scale will be used to assess emergence agitation. Aono's scale scores ≥3, 5-step (EA) scale ≥4 or PAED scale scores ≥10 will be considered as presence of emergence agitation
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 16 Jul 2015.
- Background: PubMed 20716081Chen J, Li W, Hu X, Wang D. Emergence agitation after cataract surgery in children: a comparison of midazolam, propofol and ketamine. Paediatr Anaesth. 2010 Sep;20(9):873-9. doi: 10.1111/j.1460-9592.2010.03375.x.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Administration of propofol, Administration of fentanyl and Administration of saline in people with Emergence Agitation, run by Yonsei 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 3 inclusion and 7 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 16 Jul 2015. 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?
The incidence of emergence agitation (time frame: Participants will be followed for the duration of postanesthesia care unit (PACU) stay, an expected average of one hour.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01506622, which also lists 1 linked publication.
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 16 Jul 2015.