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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02945072
Other study ID # KEK-ZH-Nr. 2011-0009
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date January 22, 2018
Est. completion date December 31, 2023

Study information

Verified date February 2021
Source University Children's Hospital, Zurich
Contact Philipp Buehler, MD
Phone +41 44 266 32 44
Email philipp.buehler@kispi.uzh.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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)


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
TIVA
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)
Sevoflurane
Sevoflurane is use to anesthesia maintenance after anesthesia induction (target et 2 Vol% in 50-70% N2O, dose adaptation as required)

Locations

Country Name City State
Switzerland Dr. Philipp Buehler Zurich

Sponsors (1)

Lead Sponsor Collaborator
University Children's Hospital, Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

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
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