- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02945072
Clinical Study of Behavior Problems in Children After Different Anesthesia Methods (PST)
February 1, 2021 updated by: University Children's Hospital, Zurich
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)
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
500
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Philipp Buehler, MD
- Phone Number: +41 44 266 32 44
- Email: philipp.buehler@kispi.uzh.ch
Study Contact Backup
- Name: Achim Schmitz, MD
- Phone Number: +41 44 266 71 04
- Email: achim.schmitz@kispi.uzh.ch
Study Locations
-
-
-
Zurich, Switzerland, 8032
- Recruiting
- Dr. Philipp Buehler
-
Contact:
- Achim Schmitz, MD
- Phone Number: +41 44 266 7104
- Email: achim.schmitz@kispi.uzh.ch
-
Contact:
- Carola Sabandal
- Phone Number: +41 44 266 32 44
- Email: carola.sabandal@kispi.uzh.ch
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 10 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Sevoflurane group
general anesthesia will be maintained with sevoflurane
|
Sevoflurane is use to anesthesia maintenance after anesthesia induction (target et 2 Vol% in 50-70% N2O, dose adaptation as required)
|
Experimental: TIVA group
general anesthesia will be maintained with total intravenous anesthesia (propofol and remifentanyl)
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively
Time Frame: first week postoperative
|
child's PHBQ score first week postoperatively
|
first week postoperative
|
Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively
Time Frame: second week postoperative
|
child's PHBQ score second week postoperatively
|
second week postoperative
|
Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively
Time Frame: fourth week postoperative
|
child's PHBQ score fourth week postoperatively
|
fourth week postoperative
|
SDQ Questionnaire score postoperatively
Time Frame: first week postoperative
|
child's SDQ score first week postoperatively
|
first week postoperative
|
SDQ Questionnaire score postoperatively
Time Frame: second week postoperative
|
child's SDQ score second week postoperatively
|
second week postoperative
|
SDQ Questionnaire score postoperatively
Time Frame: fourth week postoperative
|
child's SDQ score fourth week postoperatively
|
fourth week postoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
postoperative pain Level (by VAS)
Time Frame: in the first postoperative week (3 times a day)
|
Visual Analog Scale for Pain (VAS Pain) were used to evaluate postoperative pain level
|
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)
|
CHEOPS (Children's Hospital of Eastern Ontario Pain Scale) were used to evaluate postoperative pain level
|
in the first postoperative week (3 times a day)
|
postoperative pain medication
Time Frame: in the first postoperative week
|
All pain medications are recorded during the first postoperative week.Nurses and parents recorded all substance and application times by questionnaire.
|
in the first postoperative week
|
Intraoperative awareness
Time Frame: in the first and second postoperative day
|
In order to record an intraoperative awareness, a semistructured interview is conducted with test questions.
|
in the first and second postoperative day
|
postoperative Nausea and vomiting
Time Frame: in the first and second postoperative day
|
Nausea and Vomiting are recognized in frequency and time using a questionnaire.
|
in the first and second postoperative day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Philipp Buehler, MD, University children hosptial Zurich
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 22, 2018
Primary Completion (Anticipated)
December 31, 2023
Study Completion (Anticipated)
December 31, 2023
Study Registration Dates
First Submitted
October 13, 2016
First Submitted That Met QC Criteria
October 24, 2016
First Posted (Estimate)
October 26, 2016
Study Record Updates
Last Update Posted (Actual)
February 2, 2021
Last Update Submitted That Met QC Criteria
February 1, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KEK-ZH-Nr. 2011-0009
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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