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

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)

Study Overview

• Status: Completed
• Conditions: Problem Behavior; Child Behavior
• Intervention / Treatment: Procedure: Sevoflurane; Procedure: 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.

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Phase 4

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8032
    • Dr. Philipp Buehler

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 10 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sevoflurane group; general anesthesia will be maintained with sevoflurane	Procedure: Sevoflurane; Sevoflurane is use to anesthesia maintenance after anesthesia induction (target et 2 Vol% in 50-70% N2O, dose adaptation as required)
Experimental: TIVA group; general anesthesia will be maintained with total intravenous anesthesia (propofol and remifentanyl)	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively	child's PHBQ score first week postoperatively	first week postoperative
Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively	child's PHBQ score second week postoperatively	second week postoperative
Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively	child's PHBQ score fourth week postoperatively	fourth week postoperative
SDQ Questionnaire score postoperatively	child's SDQ score first week postoperatively	first week postoperative
SDQ Questionnaire score postoperatively	child's SDQ score second week postoperatively	second week postoperative
SDQ Questionnaire score postoperatively	child's SDQ score fourth week postoperatively	fourth week postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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
Intraoperative awareness	In order to record an intraoperative awareness, a semistructured interview is conducted with test questions.	in the first and second postoperative day
postoperative Nausea and vomiting	Nausea and Vomiting are recognized in frequency and time using a questionnaire.	in the first and second postoperative day

Collaborators and Investigators

• Sponsor: University Children's Hospital, Zurich
• Investigators: Study Chair: Philipp Buehler, MD, University children hosptial Zurich

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2018
• Primary Completion (Actual): June 4, 2024
• Study Completion (Actual): June 4, 2024

Study Registration Dates

• First Submitted: October 13, 2016
• First Submitted That Met QC Criteria: October 24, 2016
• First Posted (Estimated): October 26, 2016

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Problem Behavior; Child Behavior; postoperative behaviour problems
• Additional Relevant MeSH Terms: Behavioral Symptoms; Problem Behavior; Physiological Effects of Drugs; Anesthetics; Central Nervous System Depressants; Platelet Aggregation Inhibitors; Anesthetics, General; Anesthetics, Inhalation; Sevoflurane
• Other Study ID Numbers: KEK-ZH-Nr. 2011-0009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No