ChildPhase 4NCT02738814
Propofol for Treatment on Emergence Agitation
A Phase 4 study testing propofol in people with Child and Anesthesia Morbidity, run by Korea University Anam Hospital at 1 site in South Korea.
Trial summary
This study aimed to verify the effects of propofol for treatment on emergence agitation (EA) after sevoflurane anesthesia in pediatric strabismus surgery. Read more about this study
- Who is it for?
- Ages 3 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Child, Anesthesia Morbidity
- What is being tested?
- propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2016to Dec 2016
- Phase
- Phase 4
- 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 3 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- ASA (american society of anesthesiologists) physical status patients, aged 3-10yr, presenting for elective strabismus surgery.
Who cannot join
- Refusal by parents, neurologic disease, developmental delay, history of any previous surgery, American society of Anesthesiologists physical status score of III or IV, and airway disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Korea University Medical Center, Anam hospital
Seoul, Seongbuk-gu, 136-705
About this study
Official title: Clinical Study on the Effects of Propofol for Treatment on Emergence Agitation After Sevoflurane Anesthesia in Pediatric Strabismus Surgery
This study aimed to verify the effects of propofol for treatment on emergence agitation (EA) after sevoflurane anesthesia in pediatric strabismus surgery.
Read the detailed description
Sevoflurane with rapid anesthetic induction and emergence, hemodynamic stability, and nonirritating airway properties, has acquired widespread acceptance in children. However, sevoflurane has been reported to be associated with emergence agitation in children, with a reported incidence of up to 80%. In severe case, it cause injury to the child or to the surgical site and lead to the accidental removal of surgical dressings and intravenous catheters. In case of intense agitation with high risk of self-injury, pharmacologic intervention seems reasonable. Pharmacologic treatment of emergence agitation relies on the administration of IV sedative agents (IV midazolam 0.1 mg/kg12 or propofol 0.5 or 1 mg/kg) or opioid agents (IV fentanyl 1 or 2 mcg/kg). However, these treatments are empirical and were extrapolated from pharmacologic preventive studies performed at the end of surgery or from personal experience. To the investigators knowledge, there is no risk of recurrence of EA after a first episode. Consequently, EA is not per se a factor of increased duration of PACU (post-anaesthesia care unit ) stay, but sedative or opioid agents administered postoperatively to alleviate it might prolong this stay.
Therefore, the investigators design a study to confirm statistically effect of propofol for treatment on emergence agitation after sevoflurane anesthesia in pediatric strabismus surgery through PAED scale. Furthermore duration of PACU stay is checked after propofol administration.
- Conditions
- Child, Anesthesia Morbidity
- Being tested
- propofol
- Keywords
- emergence agitation, emergence delirium, PAED scale, The Modified Aldrete Scoring System, treatment, pediatric, sevoflurane
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofolDrug
Also called fresofol MCT 1%
When severe emergence agitation(PAED > 13) is occurred, Pharmacologic treatment of emergence agitation relies on the administration of IV propofol 0.8 or 1 mg/kg.
| Study group | Role | What they receive |
|---|---|---|
| PAED > 13 | Experimental | When severe emergence agitation(PAED is 14 or more) is occured, Pharmacologic treatment of emergence agitation relies on the administration of IV propofol 0.8 or 1 mg/kg. Receives: Drug: propofol |
| PAED < 14 | No intervention | Caregivers must first try to reassure patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Emergent Adverse Events [Safety and Tolerability]
After anesthetic emergence, investigator, nurse and attending anesthesiologist check the PAED scale every 5min, up to 2 hours until discharge from PACU. If checked PAED scale is 14 or more, attending anesthesiologist administers 1% propofol 0.8~1.0mg/kg(sedative dose). Then they check PAED scale every 5min after the arousal from sedative state until the discharge from PACU.
Measured: From just after extubation until the discharge from PACU, assessed up to 2 hours.
Secondary outcomes (1)
Duration of PACU stay
The investigator check the duration of PACU stay, defined as the interval from the time of arrival of PACU to the time of discharge from PACU, if sadisfacted to discharge criteria score(from Aldrete JA. J Clin Anesth 1995; 7:89-91), a score 9 or more is required for discharge.
Measured: From the arrival of the PACU to discharge from the PACU, assessed an average of 1hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionOct 2016 (estimated)
- Study completionDec 2016 (estimated)
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 ChildStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sangjae Park, Korea University Anam Hospital
- Investigators
- SeungZhoo Yoon, M.D.PhD., Study director, Department of Anesthesiology and Pain medicine. Korea universicy medical center.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02738814
- Sponsor's protocol ID
- ED15301
- Status last verified
- Apr 2016
- First submitted
- 1 Mar 2016
- Last updated
- 14 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Xu GS, Yoon SZ, Choi YJ, Shin HW, Kim JH. Postoperative propofol bolus treatment did not affect recovery time in patients with emergence agitation after sevoflurane anesthesia in pediatric patients undergoing strabismus surgery: Prospective nonrandomized case-control study. Medicine (Baltimore). 2022 Jul 15;101(28):e29521. doi: 10.1097/MD.0000000000029521.
PubMed 35838993
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Effects of Propofol for Treatment on Emergence Agitation After Sevoflurane Anesthesia in Pediatric Strabismus Surgery
- ClinicalTrials.gov ID
- NCT02738814
- Acronym / sponsor ID
- ED15301
- Conditions
- Child, Anesthesia Morbidity
- Keywords
- emergence agitation, emergence delirium, PAED scale, The Modified Aldrete Scoring System, treatment, pediatric, sevoflurane
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 14 Apr 2016 (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.
This study aimed to verify the effects of propofol for treatment on emergence agitation (EA) after sevoflurane anesthesia in pediatric strabismus surgery.
Detailed description
Sevoflurane with rapid anesthetic induction and emergence, hemodynamic stability, and nonirritating airway properties, has acquired widespread acceptance in children. However, sevoflurane has been reported to be associated with emergence agitation in children, with a reported incidence of up to 80%. In severe case, it cause injury to the child or to the surgical site and lead to the accidental removal of surgical dressings and intravenous catheters. In case of intense agitation with high risk of self-injury, pharmacologic intervention seems reasonable. Pharmacologic treatment of emergence agitation relies on the administration of IV sedative agents (IV midazolam 0.1 mg/kg12 or propofol 0.5 or 1 mg/kg) or opioid agents (IV fentanyl 1 or 2 mcg/kg). However, these treatments are empirical and were extrapolated from pharmacologic preventive studies performed at the end of surgery or from personal experience. To the investigators knowledge, there is no risk of recurrence of EA after a first episode. Consequently, EA is not per se a factor of increased duration of PACU (post-anaesthesia care unit ) stay, but sedative or opioid agents administered postoperatively to alleviate it might prolong this stay.
Therefore, the investigators design a study to confirm statistically effect of propofol for treatment on emergence agitation after sevoflurane anesthesia in pediatric strabismus surgery through PAED scale. Furthermore duration of PACU stay is checked after propofol administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PAED > 13 | Experimental | Drug: propofolWhen severe emergence agitation(PAED is 14 or more) is occured, Pharmacologic treatment of emergence agitation relies on the administration of IV propofol 0.8 or 1 mg/kg. |
| PAED < 14 | No intervention | –Caregivers must first try to reassure patients. |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- ASA (american society of anesthesiologists) physical status patients, aged 3-10yr, presenting for elective strabismus surgery.
Key exclusion criteria (1 listed)
- Refusal by parents, neurologic disease, developmental delay, history of any previous surgery, American society of Anesthesiologists physical status score of III or IV, and 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 |
|---|---|---|
| propofolAlso: fresofol MCT 1%When severe emergence agitation(PAED > 13) is occurred, Pharmacologic treatment of emergence agitation relies on the administration of IV propofol 0.8 or 1 mg/kg. | Drug | PAED > 13 |
Primary outcome
Change of Emergent Adverse Events [Safety and Tolerability]
Time frame: From just after extubation until the discharge from PACU, assessed up to 2 hours.
After anesthetic emergence, investigator, nurse and attending anesthesiologist check the PAED scale every 5min, up to 2 hours until discharge from PACU. If checked PAED scale is 14 or more, attending anesthesiologist administers 1% propofol 0.8~1.0mg/kg(sedative dose). Then they check PAED scale every 5min after the arousal from sedative state until the discharge from PACU.
1 secondary outcome
Duration of PACU stay
Time frame: From the arrival of the PACU to discharge from the PACU, assessed an average of 1hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
- Derived from this study: PubMed 35838993Xu GS, Yoon SZ, Choi YJ, Shin HW, Kim JH. Postoperative propofol bolus treatment did not affect recovery time in patients with emergence agitation after sevoflurane anesthesia in pediatric patients undergoing strabismus surgery: Prospective nonrandomized case-control study. Medicine (Baltimore). 2022 Jul 15;101(28):e29521. doi: 10.1097/MD.0000000000029521.
- 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.
SeungZhoo Yoon, M.D.PhD. study director
Department of Anesthesiology and Pain medicine. Korea universicy medical center.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing propofol in people with Child and Anesthesia Morbidity, run by Korea University Anam 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 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: status not confirmed, as of the sponsor's last update on 14 Apr 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Change of Emergent Adverse Events [Safety and Tolerability] (time frame: From just after extubation until the discharge from PACU, assessed up to 2 hours.). 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 NCT02738814, 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 14 Apr 2016.