AgitationPhase 4NCT02428283
Scalp Nerve Block on Emergence Agitation
A Phase 4 study testing Ropivacaine, Remifentanil and Sevoflurane in people with Agitation, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
Emergence agitation is a common problem in children during recovery from sevoflurane anesthesia. Pain is considered as a cause of postoperative emergence agitation and compounding factor of agitation assessment in children. Read more about this study
- Who is it for?
- Ages 1 year to 7 years
- Conditions the study is for
- Agitation
- What is being tested?
- Ropivacaine, Remifentanil and Sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2015to Nov 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 1 year to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA I-II patients undergoing general anesthesia for nevus surgery
Who cannot join
- developmental disorder
- neurologic disorder
- coaguloparthy
- allergy to local anesthetics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Scalp Nerve Block on the Emergence Agitation in Children Undergoing Nevus Surgery During Sevoflurane Anesthesia
Emergence agitation is a common problem in children during recovery from sevoflurane anesthesia. Pain is considered as a cause of postoperative emergence agitation and compounding factor of agitation assessment in children. The purpose of this study was to investigate the effect of scalp nerve block on the emergence agitation in children undergoing nevus surgery during sevoflurane anesthesia.
Read the detailed description
Forty-four children, 1-7 years old, undergoing nevus surgery on head were enrolled. Anesthesia was induced with thiopental sodium and rocuronium, and maintained with sevoflurane. Patients were randomly assigned two groups: the control group received IV remifentanil 1 μg/kg, and the block group received scalp nerve block with 0.25% ropivacaine 2-3 ml. Time to tracheal extubation, recovery time, hemodynamic change, FLACC score, and Watcha behavior scale for emergence agitation were assessed.
- Conditions
- Agitation
- Being tested
- Ropivacaine, Remifentanil, Sevoflurane
- Medical subject headings
- Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
0.25% ropivacaine 2-3 ml was injected around the scalp nerves that are located on the head.
RemifentanilDrug
Also called Ultiva
Remifentanil 1 μg/kg was injected before skin incision.
SevofluraneDrug
Anesthesia was titrated with sevoflurane, maintaining mean arterial pressure and heart rate within 20% baseline value.
| Study group | Role | What they receive |
|---|---|---|
| Nerve block | Experimental | Scalp nerve block was performed with 0.25% ropivacaine. Receives: Drug: Ropivacaine; Drug: Sevoflurane |
| Control | Active comparator | Remifentanil was administered intravenously. Receives: Drug: Remifentanil; Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of Watcha behavior scale for emergence agitation (4 point)
Measured: from immediately after PACU arrival to 10 min, 20 min, and 30 min after arrival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Yeop Kim, Ajou University School of Medicine
- Investigators
- Jong Yeop Kim, MD, Study director, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02428283
- Sponsor's protocol ID
- AJIRB-MED-CT4-14-422
- Status last verified
- Jan 2017
- First submitted
- 21 Apr 2015
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Scalp Nerve Block on the Emergence Agitation in Children Undergoing Nevus Surgery During Sevoflurane Anesthesia
- ClinicalTrials.gov ID
- NCT02428283
- Acronym / sponsor ID
- AJIRB-MED-CT4-14-422
- Conditions
- Agitation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 28 Apr 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.
Emergence agitation is a common problem in children during recovery from sevoflurane anesthesia. Pain is considered as a cause of postoperative emergence agitation and compounding factor of agitation assessment in children. The purpose of this study was to investigate the effect of scalp nerve block on the emergence agitation in children undergoing nevus surgery during sevoflurane anesthesia.
Detailed description
Forty-four children, 1-7 years old, undergoing nevus surgery on head were enrolled. Anesthesia was induced with thiopental sodium and rocuronium, and maintained with sevoflurane. Patients were randomly assigned two groups: the control group received IV remifentanil 1 μg/kg, and the block group received scalp nerve block with 0.25% ropivacaine 2-3 ml. Time to tracheal extubation, recovery time, hemodynamic change, FLACC score, and Watcha behavior scale for emergence agitation were assessed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nerve block | Experimental | Drug: Ropivacaine, Drug: SevofluraneScalp nerve block was performed with 0.25% ropivacaine. |
| Control | Active comparator | Drug: Remifentanil, Drug: SevofluraneRemifentanil was administered intravenously. |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- ASA I-II patients undergoing general anesthesia for nevus surgery
Key exclusion criteria (4 listed)
- developmental disorder
- neurologic disorder
- coaguloparthy
- allergy to local anesthetics
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 |
|---|---|---|
| Ropivacaine0.25% ropivacaine 2-3 ml was injected around the scalp nerves that are located on the head. | Drug | Nerve block |
| RemifentanilAlso: UltivaRemifentanil 1 μg/kg was injected before skin incision. | Drug | Control |
| SevofluraneAnesthesia was titrated with sevoflurane, maintaining mean arterial pressure and heart rate within 20% baseline value. | Drug | Control, Nerve block |
Primary outcome
change of Watcha behavior scale for emergence agitation (4 point)
Time frame: from immediately after PACU arrival to 10 min, 20 min, and 30 min after arrival
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 25 Jan 2017.
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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.
Jong Yeop Kim, MD study director
Ajou University School of Medicine
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 Ropivacaine, Remifentanil and Sevoflurane in people with Agitation, run by Ajou University School of Medicine 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 25 Jan 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.
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?
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?
change of Watcha behavior scale for emergence agitation (4 point) (time frame: from immediately after PACU arrival to 10 min, 20 min, and 30 min after arrival). 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 25 Jan 2017.