Child Behavior Clinical Trial
— PSTOfficial 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)
Status | Recruiting |
Enrollment | 500 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 2 Years to 10 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Dr. Philipp Buehler | Zurich |
Lead Sponsor | Collaborator |
---|---|
University Children's Hospital, Zurich |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively | child's PHBQ score first week postoperatively | first week postoperative | |
Primary | Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively | child's PHBQ score second week postoperatively | second week postoperative | |
Primary | Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively | child's PHBQ score fourth week postoperatively | fourth week postoperative | |
Primary | SDQ Questionnaire score postoperatively | child's SDQ score first week postoperatively | first week postoperative | |
Primary | SDQ Questionnaire score postoperatively | child's SDQ score second week postoperatively | second week postoperative | |
Primary | SDQ Questionnaire score postoperatively | child's SDQ score fourth week postoperatively | fourth week postoperative | |
Secondary | postoperative pain Level (by VAS) | Visual Analog Scale for Pain (VAS Pain) were used to evaluate postoperative pain level | in the first postoperative week (3 times a day) | |
Secondary | postoperative pain Level (by CHEOPS) | 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) | |
Secondary | postoperative pain medication | 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 | |
Secondary | Intraoperative awareness | In order to record an intraoperative awareness, a semistructured interview is conducted with test questions. | in the first and second postoperative day | |
Secondary | postoperative Nausea and vomiting | Nausea and Vomiting are recognized in frequency and time using a questionnaire. | in the first and second postoperative day |
Status | Clinical Trial | Phase | |
---|---|---|---|
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