Child BehaviorPhase 4PSTNCT02945072
Clinical Study of Behavior Problems in Children After Different Anesthesia Methods
A Phase 4 study testing TIVA and Sevoflurane in people with Child Behavior and Problem Behavior, run by University Children's Hospital, Zurich at 1 site in Switzerland.
Trial summary
The aim of this study is to investigate long-lasting or later behavioral changes in children in the context of different anesthesia techniques (Inhalation anesthesia vs. TIVA) Read more about this study
- Who is it for?
- Ages 2 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Behavior, Problem Behavior
- What is being tested?
- TIVA and Sevoflurane
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteSwitzerland
- Study dates
- 22 Jan 2018to 4 Jun 2024
- 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 2 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- elective Operation
- operation in general anesthesia in combination with regional anesthesia
- Age 2-10 years
- ASA classification 1 or 2 (without severe basic disease or disability)
Who cannot join
- Lack of Consensus
- general anesthesia during the last 3 months before or 4 weeks after the procedure
- PONV prophylaxis with droperidol
- severe known growth factor
- mental pre-existing conditions and behavioral abnormalities
- contraindications for one of the used study medications
- insufficient regional anesthesia
- secondary intervention within of the 4-week follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Behavior in Children: A Comparison of Inhalation Anesthesia (Sevoflurane) Versus Total Intravenous Anesthesia (TIVA)
The aim of this study is to investigate long-lasting or later behavioral changes in children in the context of different anesthesia techniques (Inhalation anesthesia vs. TIVA)
Read the detailed description
The process of surgery and anaesthesia can be an extremely frightening and stressful event for a child, and is frequently followed by negative postoperative behavioural changes. This Event could be associated with poor postoperative outcome and long term behavior problems like anxiety, eating or sleeping disorders. The aim of this study is to investigate long-lasting or later behavioral changes in children in the context of different anesthesia techniques (Inhalation anesthesia vs. TIVA). After anesthesia initiation, anesthesia maintenance should be done with sevoflurane or Tiva. The effect of behavioral changes in children in the context of anesthesia techniques should be evaluate by post hospitalisation behavior and Strengths and Difficulties Questionnaire at first, second and fourth week. Early postoperative problems like postoperative nausea and vomiting, pain level, pain therapy and postoperative awareness should be evaluate too.
- Conditions
- Child Behavior, Problem Behavior
- Being tested
- TIVA, Sevoflurane
- Keywords
- Child Behavior, Problem Behavior, postoperative behaviour problems
- Medical subject headings
- Child Behavior, Problem Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIVAProcedure or surgery
TIVA is use to anesthesia maintenance after anesthesia induction (Propofol 10mg/kg/h, Remifentanil 0.2mcg/kg/min, dose adaptation as required for sufficient anesthesia)
SevofluraneProcedure or surgery
Sevoflurane is use to anesthesia maintenance after anesthesia induction (target et 2 Vol% in 50-70% N2O, dose adaptation as required)
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane group | Active comparator | general anesthesia will be maintained with sevoflurane Receives: Procedure: Sevoflurane |
| TIVA group | Experimental | general anesthesia will be maintained with total intravenous anesthesia (propofol and remifentanyl) Receives: Procedure: TIVA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively
child's PHBQ score first week postoperatively
Measured: first week postoperative
Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively
child's PHBQ score second week postoperatively
Measured: second week postoperative
Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively
child's PHBQ score fourth week postoperatively
Measured: fourth week postoperative
SDQ Questionnaire score postoperatively
child's SDQ score first week postoperatively
Measured: first week postoperative
SDQ Questionnaire score postoperatively
child's SDQ score second week postoperatively
Measured: second week postoperative
SDQ Questionnaire score postoperatively
child's SDQ score fourth week postoperatively
Measured: fourth week postoperative
Secondary outcomes (5)
postoperative pain Level (by VAS)
Visual Analog Scale for Pain (VAS Pain) were used to evaluate postoperative pain level
Measured: in the first postoperative week (3 times a day)
postoperative pain Level (by CHEOPS)
CHEOPS (Children's Hospital of Eastern Ontario Pain Scale) were used to evaluate postoperative pain level
Measured: in the first postoperative week (3 times a day)
postoperative pain medication
All pain medications are recorded during the first postoperative week.Nurses and parents recorded all substance and application times by questionnaire.
Measured: in the first postoperative week
Intraoperative awareness
In order to record an intraoperative awareness, a semistructured interview is conducted with test questions.
Measured: in the first and second postoperative day
postoperative Nausea and vomiting
Nausea and Vomiting are recognized in frequency and time using a questionnaire.
Measured: in the first and second postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study start22 Jan 2018
- Primary completion4 Jun 2024
- Study completion4 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child BehaviorStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philipp Buehler, MD, Study chair, University children hosptial Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02945072
- Sponsor's protocol ID
- KEK-ZH-Nr. 2011-0009
- Acronym
- PST
- Status last verified
- Dec 2024
- First submitted
- 13 Oct 2016
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Behavior in Children: A Comparison of Inhalation Anesthesia (Sevoflurane) Versus Total Intravenous Anesthesia (TIVA)
- ClinicalTrials.gov ID
- NCT02945072
- Acronym / sponsor ID
- PST / KEK-ZH-Nr. 2011-0009
- Conditions
- Child Behavior, Problem Behavior
- Keywords
- Child Behavior, Problem Behavior, postoperative behaviour problems
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Study start
- 22 Jan 2018 (actual)
- Primary completion
- 4 Jun 2024 (actual)
- Study completion
- 4 Jun 2024 (actual)
- First posted
- 26 Oct 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.
The aim of this study is to investigate long-lasting or later behavioral changes in children in the context of different anesthesia techniques (Inhalation anesthesia vs. TIVA)
Detailed description
The process of surgery and anaesthesia can be an extremely frightening and stressful event for a child, and is frequently followed by negative postoperative behavioural changes. This Event could be associated with poor postoperative outcome and long term behavior problems like anxiety, eating or sleeping disorders. The aim of this study is to investigate long-lasting or later behavioral changes in children in the context of different anesthesia techniques (Inhalation anesthesia vs. TIVA). After anesthesia initiation, anesthesia maintenance should be done with sevoflurane or Tiva. The effect of behavioral changes in children in the context of anesthesia techniques should be evaluate by post hospitalisation behavior and Strengths and Difficulties Questionnaire at first, second and fourth week. Early postoperative problems like postoperative nausea and vomiting, pain level, pain therapy and postoperative awareness should be evaluate too.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane group | Active comparator | Procedure: Sevofluranegeneral anesthesia will be maintained with sevoflurane |
| TIVA group | Experimental | Procedure: TIVAgeneral anesthesia will be maintained with total intravenous anesthesia (propofol and remifentanyl) |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- elective Operation
- operation in general anesthesia in combination with regional anesthesia
- Age 2-10 years
- ASA classification 1 or 2 (without severe basic disease or disability)
Key exclusion criteria (8 listed)
- Lack of Consensus
- general anesthesia during the last 3 months before or 4 weeks after the procedure
- PONV prophylaxis with droperidol
- severe known growth factor
- mental pre-existing conditions and behavioral abnormalities
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 |
|---|---|---|
| TIVATIVA is use to anesthesia maintenance after anesthesia induction (Propofol 10mg/kg/h, Remifentanil 0.2mcg/kg/min, dose adaptation as required for sufficient anesthesia) | Procedure or surgery | TIVA group |
| SevofluraneSevoflurane is use to anesthesia maintenance after anesthesia induction (target et 2 Vol% in 50-70% N2O, dose adaptation as required) | Procedure or surgery | Sevoflurane group |
Primary outcome
Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively
Time frame: first week postoperative
child's PHBQ score first week postoperatively
Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively
Time frame: second week postoperative
child's PHBQ score second week postoperatively
Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively
Time frame: fourth week postoperative
child's PHBQ score fourth week postoperatively
SDQ Questionnaire score postoperatively
Time frame: first week postoperative
child's SDQ score first week postoperatively
SDQ Questionnaire score postoperatively
Time frame: second week postoperative
child's SDQ score second week postoperatively
SDQ Questionnaire score postoperatively
Time frame: fourth week postoperative
child's SDQ score fourth week postoperatively
5 secondary outcomes
postoperative pain Level (by VAS)
Time frame: in the first postoperative week (3 times a day)
postoperative pain Level (by CHEOPS)
Time frame: in the first postoperative week (3 times a day)
postoperative pain medication
Time frame: in the first postoperative week
Intraoperative awareness
Time frame: in the first and second postoperative day
postoperative Nausea and vomiting
Time frame: in the first and second postoperative day
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 19 Dec 2024.
- 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.
Philipp Buehler, MD study chair
University children hosptial Zurich
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 TIVA and Sevoflurane in people with Child Behavior and Problem Behavior, run by University Children's Hospital, Zurich at 1 site in Switzerland.
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 4 inclusion and 8 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 19 Dec 2024. 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 Switzerland. 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?
Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively (time frame: first week postoperative). The study lists 6 primary outcomes in all. 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 19 Dec 2024.