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Clinical Study of Behavior Problems in Children After Different Anesthesia Methods

NCT ID: NCT02945072

Last Updated: 2024-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-22

Study Completion Date

2024-06-04

Brief Summary

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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

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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

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Child Behavior Problem Behavior

Keywords

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Child Behavior Problem Behavior postoperative behaviour problems

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sevoflurane group

general anesthesia will be maintained with sevoflurane

Group Type ACTIVE_COMPARATOR

Sevoflurane

Intervention Type PROCEDURE

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

TIVA group

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

Group Type EXPERIMENTAL

TIVA

Intervention Type PROCEDURE

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)

Interventions

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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)

Intervention Type PROCEDURE

Sevoflurane

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Children's Hospital, Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philipp Buehler, MD

Role: STUDY_CHAIR

University children hosptial Zurich

Locations

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Dr. Philipp Buehler

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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KEK-ZH-Nr. 2011-0009

Identifier Type: -

Identifier Source: org_study_id