NCT02945072

Clinical Study of Behavior Problems in Children After Different Anesthesia Methods

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: University Children's Hospital, Zurich · Academic / Other
• Sex: All
• Age: 2 Years – 10 Years
• Healthy volunteers: Accepted

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)

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.

Conditions

• Child Behavior
• Problem Behavior

Interventions

Type	Name	Description
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)
PROCEDURE	Sevoflurane	Sevoflurane is use to anesthesia maintenance after anesthesia induction (target et 2 Vol% in 50-70% N2O, dose adaptation as required)

Timeline

• Start date: 2018-01-22
• Primary completion: 2024-06-04
• Completion: 2024-06-04
• First posted: 2016-10-26
• Last updated: 2024-12-19

Locations

1 site across 1 country: Switzerland