Emergence AgitationNCT03252405
Effect of Induction Method in Post Operative Agitation
A study testing mask ventilation and intravenous cannulation in people with Emergence Agitation, run by Ahi Evran University Education and Research Hospital at 2 sites in Turkey (Türkiye).
Trial summary
To compare the effect of two different induction method; mask ventilation and intravenous cannulation on emergence agitation on pediatric adenotonsillectomy Read more about this study
- Who is it for?
- Ages 2 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Emergence Agitation
- What is being tested?
- mask ventilation and intravenous cannulation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 2 Aug 2017to 30 Oct 2017
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- pediatric adenotonsillectomy
Who cannot join
- patients with neurological, hepatic, renal disorders and using any drugs
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Dışkapı Yıldırım Beyazıt Education and research hospital
Ankara
Ahi evran university education and research hospital
Kırşehir
About this study
Official title: the Effect of Two Different Method; Mask Ventilation or Intravenous Canulation on Emergence Agitation and Recovery Conditions on Pediatric Adenotonsillectomy
To compare the effect of two different induction method; mask ventilation and intravenous cannulation on emergence agitation on pediatric adenotonsillectomy
Read the detailed description
Many things cause emergence agitation after operations on pediatric population. This research aims determine which method, mask ventilation or intravenous cannulatin is more effective on emergence agitation
- Conditions
- Emergence Agitation
- Being tested
- mask ventilation, intravenous cannulation
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mask ventilationDevice
Also called induction method with mask ventilation
before intravenous induction, mask application is made. then intravenous cannulation and induction
intravenous cannulationDevice
Also called induction method with intravenous cannulation
induction is applied by using intravenous cannulation
| Study group | Role | What they receive |
|---|---|---|
| mask ventilation | Active comparator | induction is made with mask ventilation Receives: Device: mask ventilation; Device: intravenous cannulation |
| intravenous induction | Experimental | induction is made with intravenous cannulation Receives: Device: intravenous cannulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
assess changing in pediatric agitation/ emergence delirium scale(PAED) scores
to asses change of intensity of postoperative emergence agitation/ delirium (PAED) by using pediatric agitation emergence delirium scale with scores. to assess changing PAED scores at one hour after transfer into the post anesthesia care unit.
Measured: postoperative first hour
Secondary outcomes (1)
FLACC (face, legs,activity, cry, consolobility)
to asses postoperative pain intensity with scores by FLACC (face, legs,activity, cry, consolobility) scale after transfer into the post anesthesia care unit
Measured: postoperative first hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study start2 Aug 2017
- Primary completion30 Oct 2017
- Study completion30 Oct 2017
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.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahi Evran University Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevser Peker, Ahi Evran University Education and Research Hospital
- Investigators
- kevser peker, Principal investigator, Ahi Evran University Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03252405
- Sponsor's protocol ID
- emergence agitation
- Status last verified
- Sep 2019
- First submitted
- 8 Aug 2017
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Peker K, Polat R. Effects of intravenous and mask induction on post-operative emergence delirium in pediatric patients undergoing tonsillectomy with or without adenoidectomy. Ir J Med Sci. 2020 Aug;189(3):1061-1068. doi: 10.1007/s11845-020-02197-4. Epub 2020 Feb 11.
PubMed 32048203
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effect of Two Different Method; Mask Ventilation or Intravenous Canulation on Emergence Agitation and Recovery Conditions on Pediatric Adenotonsillectomy
- ClinicalTrials.gov ID
- NCT03252405
- Acronym / sponsor ID
- emergence agitation
- Conditions
- Emergence Agitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Ahi Evran University Education and Research HospitalUniversity, hospital or other
- Study start
- 2 Aug 2017 (actual)
- Primary completion
- 30 Oct 2017 (actual)
- Study completion
- 30 Oct 2017 (actual)
- First posted
- 17 Aug 2017 (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.
To compare the effect of two different induction method; mask ventilation and intravenous cannulation on emergence agitation on pediatric adenotonsillectomy
Detailed description
Many things cause emergence agitation after operations on pediatric population. This research aims determine which method, mask ventilation or intravenous cannulatin is more effective on emergence agitation
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mask ventilation | Active comparator | Device: mask ventilation, Device: intravenous cannulationinduction is made with mask ventilation |
| intravenous induction | Experimental | Device: intravenous cannulationinduction is made with intravenous cannulation |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- pediatric adenotonsillectomy
Key exclusion criteria (1 listed)
- patients with neurological, hepatic, renal disorders and using any drugs
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 |
|---|---|---|
| mask ventilationAlso: induction method with mask ventilationbefore intravenous induction, mask application is made. then intravenous cannulation and induction | Device | mask ventilation |
| intravenous cannulationAlso: induction method with intravenous cannulationinduction is applied by using intravenous cannulation | Device | intravenous induction, mask ventilation |
Primary outcome
assess changing in pediatric agitation/ emergence delirium scale(PAED) scores
Time frame: postoperative first hour
to asses change of intensity of postoperative emergence agitation/ delirium (PAED) by using pediatric agitation emergence delirium scale with scores. to assess changing PAED scores at one hour after transfer into the post anesthesia care unit.
1 secondary outcome
FLACC (face, legs,activity, cry, consolobility)
Time frame: postoperative first hour
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 2 Oct 2019.
- Derived from this study: PubMed 32048203Peker K, Polat R. Effects of intravenous and mask induction on post-operative emergence delirium in pediatric patients undergoing tonsillectomy with or without adenoidectomy. Ir J Med Sci. 2020 Aug;189(3):1061-1068. doi: 10.1007/s11845-020-02197-4. Epub 2020 Feb 11.
- Individual participant dataSharing planned: Undecided
Related trials for Emergence Agitation
Not yet recruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruitingObservational study
Prospective Observational Multimodal Neuromonitoring During High-Risk Adult Surgery
Postoperative Cognitive Complications, Delirium
Recruiting
Mechanisms and Intervention Strategies of Perioperative Glycemic Variability on Postoperative Delirium
Cardiac Surgery With Cardiopulmonary Bypass, Postoperative Delirium
Not yet recruiting
Intranasal Dexmedetomidine Combined With Esketamine for Emergence Quality After Suspension Laryngoscopy
Emergence Agitation, Vocal Cord Polyps
RecruitingObservational study
Immunonutrition and Neuromonitoring for Postoperative Delirium in Gynecologic Oncology
Postoperative Delirium (POD), Gynecologic Cancers
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.
kevser peker principal investigator
Ahi Evran University Education and Research Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mask ventilation and intravenous cannulation in people with Emergence Agitation, run by Ahi Evran University Education and Research Hospital at 2 sites in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 2 Oct 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 Turkey (Türkiye). 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?
assess changing in pediatric agitation/ emergence delirium scale(PAED) scores (time frame: postoperative first 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 NCT03252405, 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 2 Oct 2019.