Clinical Study of Behavior Problems in Children After Different Anesthesia Methods

Child Behavior Clinical Trial

— PST  

Official title:

Postoperative Behavior in Children: A Comparison of Inhalation Anesthesia (Sevoflurane) Versus Total Intravenous Anesthesia (TIVA)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02945072
• Other study ID #: KEK-ZH-Nr. 2011-0009
• Status: Recruiting
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Child Behavior
• Problem Behavior

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