Clinical Study of Behavior Problems in Children After Different Anesthesia Methods (PST)

University of Zurich (UZH)

Status and phase: Completed; Phase 4

Conditions: Child Behavior; Problem Behavior

Treatments: Procedure: Sevoflurane; Procedure: TIVA

Study type: Interventional

Funder types: Other

Identifiers

NCT02945072

KEK-ZH-Nr. 2011-0009

Details and patient eligibility

About

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)

Full 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.

Enrollment: 500 patients

Sex: All

Ages: 2 to 10 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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500 participants in 2 patient groups

Sevoflurane group

Active Comparator group

Description:

general anesthesia will be maintained with sevoflurane

Treatment:

Procedure: Sevoflurane

TIVA group

Experimental group

Description:

general anesthesia will be maintained with total intravenous anesthesia (propofol and remifentanyl)

Treatment:

Procedure: TIVA