Emergence DeliriumNCT03330613
Emergence Delirium and Recovery Time in Children
A study testing PAEDS, TIVA and Inhalational anesthesia in people with Emergence Delirium, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
In this study, inhalation anesthesia procedure and intravenous anesthesia method will be compared in terms of emergence delirium and recovery time in children who are scheduled for dental treatment under general anesthesia. Read more about this study
- Who is it for?
- Ages 3 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Emergence Delirium
- What is being tested?
- PAEDS, TIVA and Inhalational anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2017to 20 Jul 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 3 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Indication of dental treatment under general anesthesia.
- No systemic disease (ASA1).
- Child and parent agree to participate in the work
Who cannot join
- Do not accept to participate in the work.
- The child is not systemically healthy.
- Children with allergies to general anesthetic drugs.
- Contraindicated children to take general anesthesia
- Children with upper respiratory tract infection on the day of operation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ozlem Kocaturk
Aydin, 09100
Ozlem Kocaturk, 5367730400, ozlemoget2002@yahoo.com
About this study
Official title: Emergence Delirium and Recovery Time in Children: a Randomized Trial to Compare Total Intravenous Anesthesia With Propofol to Inhalational Sevoflurane Anesthesia for Ambulatory Dental Surgery
In this study, inhalation anesthesia procedure and intravenous anesthesia method will be compared in terms of emergence delirium and recovery time in children who are scheduled for dental treatment under general anesthesia.
Read the detailed description
Pediatric Anesthesia Early Delirium Scale (PAEDS) will be used to evaluate postoperative emergence delirium.
- Conditions
- Emergence Delirium
- Being tested
- PAEDS, TIVA, Inhalational anesthesia
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAEDSDiagnostic test
pediatric emergency delirium scale
TIVAProcedure or surgery
Total intravenous anesthesia with propofol
Inhalational anesthesiaProcedure or surgery
Inhalational (volatile) anesthesia with sevoflurane
| Study group | Role | What they receive |
|---|---|---|
| Inhalational anesthesia | Other | Inhalational anesthesia is an anesthesia procedure using by respiratory tract. PAEDS used to for postanesthesia pediatric patients. Receives: Diagnostic Test: PAEDS; Procedure: TIVA; Procedure: Inhalational anesthesia |
| Total intravenous anesthesia | Active comparator | Total intravenous anesthesia (TIVA) is an anesthesia procedure using vascular infusion method.PAEDS used to for postanesthesia pediatric patients. Receives: Diagnostic Test: PAEDS; Procedure: TIVA; Procedure: Inhalational anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergence delirium
Pediatric Anesthesia Early Delirium Scale (PAED) will be used to assess postoperative agitation.
Point Description Not at all Just a little Quite a bit Very much Extremely
- The child makes eye contact with the caregiver 4 3 2 1 0
- The child's actions are purposeful 4 3 2 1 0
- The child is aware of his/her surroundings 4 3 2 1 0
- The child is restless 0 1 2 3 4
- The child is inconsolable 0 1 2 3 4
The Pediatric Anesthesia Emergence Delirium Scale
Measured: 6 hours
Secondary outcomes (1)
Recovery time
The period of stay at the post-anesthesia care unit
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start15 Nov 2017
- Primary completion15 Jul 2018 (estimated)
- Study completion20 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Emergence DeliriumStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes 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
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozlem Kocaturk, Aydin Adnan Menderes University
- Investigators
- Ozlem Kocaturk, Principal investigator, Faculty of Dentistry, Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03330613
- Sponsor's protocol ID
- 2017/17
- Status last verified
- Jul 2018
- First submitted
- 20 Oct 2017
- Last updated
- 11 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chandler JR, Myers D, Mehta D, Whyte E, Groberman MK, Montgomery CJ, Ansermino JM. Emergence delirium in children: a randomized trial to compare total intravenous anesthesia with propofol and remifentanil to inhalational sevoflurane anesthesia. Paediatr Anaesth. 2013 Apr;23(4):309-15. doi: 10.1111/pan.12090.
PubMed 23464658Konig MW, Varughese AM, Brennen KA, Barclay S, Shackleford TM, Samuels PJ, Gorman K, Ellis J, Wang Y, Nick TG. Quality of recovery from two types of general anesthesia for ambulatory dental surgery in children: a double-blind, randomized trial. Paediatr Anaesth. 2009 Aug;19(8):748-55. doi: 10.1111/j.1460-9592.2009.03054.x. Epub 2009 Jun 15.
PubMed 19538532
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergence Delirium and Recovery Time in Children: a Randomized Trial to Compare Total Intravenous Anesthesia With Propofol to Inhalational Sevoflurane Anesthesia for Ambulatory Dental Surgery
- ClinicalTrials.gov ID
- NCT03330613
- Acronym / sponsor ID
- 2017/17
- Conditions
- Emergence Delirium
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 15 Jul 2018 (estimated)
- Study completion
- 20 Jul 2018 (estimated)
- First posted
- 6 Nov 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.
In this study, inhalation anesthesia procedure and intravenous anesthesia method will be compared in terms of emergence delirium and recovery time in children who are scheduled for dental treatment under general anesthesia.
Detailed description
Pediatric Anesthesia Early Delirium Scale (PAEDS) will be used to evaluate postoperative emergence delirium.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhalational anesthesia | Other | Diagnostic Test: PAEDS, Procedure: TIVA, Procedure: Inhalational anesthesiaInhalational anesthesia is an anesthesia procedure using by respiratory tract. PAEDS used to for postanesthesia pediatric patients. |
| Total intravenous anesthesia | Active comparator | Diagnostic Test: PAEDS, Procedure: TIVA, Procedure: Inhalational anesthesiaTotal intravenous anesthesia (TIVA) is an anesthesia procedure using vascular infusion method.PAEDS used to for postanesthesia pediatric patients. |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Indication of dental treatment under general anesthesia.
- No systemic disease (ASA1).
- Child and parent agree to participate in the work
Key exclusion criteria (5 listed)
- Do not accept to participate in the work.
- The child is not systemically healthy.
- Children with allergies to general anesthetic drugs.
- Contraindicated children to take general anesthesia
- Children with upper respiratory tract infection on the day of operation
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 |
|---|---|---|
| PAEDSpediatric emergency delirium scale | Diagnostic test | Inhalational anesthesia, Total intravenous anesthesia |
| TIVATotal intravenous anesthesia with propofol | Procedure or surgery | Inhalational anesthesia, Total intravenous anesthesia |
| Inhalational anesthesiaInhalational (volatile) anesthesia with sevoflurane | Procedure or surgery | Inhalational anesthesia, Total intravenous anesthesia |
Primary outcome
Emergence delirium
Time frame: 6 hours
Pediatric Anesthesia Early Delirium Scale (PAED) will be used to assess postoperative agitation. Point Description Not at all Just a little Quite a bit Very much Extremely 1. The child makes eye contact with the caregiver 4 3 2 1 0 2. The child's actions are purposeful 4 3 2 1 0 3. The child is aware of his/her surroundings 4 3 2 1 0 4. The child is restless 0 1 2 3 4 5. The child is inconsolable 0 1 2 3 4 The Pediatric Anesthesia Emergence Delirium Scale
1 secondary outcome
Recovery time
Time frame: 6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
- Background: PubMed 23464658Chandler JR, Myers D, Mehta D, Whyte E, Groberman MK, Montgomery CJ, Ansermino JM. Emergence delirium in children: a randomized trial to compare total intravenous anesthesia with propofol and remifentanil to inhalational sevoflurane anesthesia. Paediatr Anaesth. 2013 Apr;23(4):309-15. doi: 10.1111/pan.12090.
- Background: PubMed 19538532Konig MW, Varughese AM, Brennen KA, Barclay S, Shackleford TM, Samuels PJ, Gorman K, Ellis J, Wang Y, Nick TG. Quality of recovery from two types of general anesthesia for ambulatory dental surgery in children: a double-blind, randomized trial. Paediatr Anaesth. 2009 Aug;19(8):748-55. doi: 10.1111/j.1460-9592.2009.03054.x. Epub 2009 Jun 15.
- 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.
Ozlem Kocaturk principal investigator
Faculty of Dentistry, Adnan Menderes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PAEDS, TIVA and Inhalational anesthesia in people with Emergence Delirium, run by Aydin Adnan Menderes University at 1 site 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 3 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: status not confirmed, as of the sponsor's last update on 11 Jul 2018. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ozlem Kocaturk (5367730400, ozlemoget2002@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emergence delirium (time frame: 6 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 NCT03330613, which also lists 2 linked publications.
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 11 Jul 2018.