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

February 1, 2021 updated by: University Children's Hospital, Zurich

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

Recruiting

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 (Anticipated)

500

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 10 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sevoflurane group
general anesthesia will be maintained with 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)
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
Time Frame: first week postoperative
child's PHBQ score first week postoperatively
first week postoperative
Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively
Time Frame: second week postoperative
child's PHBQ score second week postoperatively
second week postoperative
Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively
Time Frame: fourth week postoperative
child's PHBQ score fourth week postoperatively
fourth week postoperative
SDQ Questionnaire score postoperatively
Time Frame: first week postoperative
child's SDQ score first week postoperatively
first week postoperative
SDQ Questionnaire score postoperatively
Time Frame: second week postoperative
child's SDQ score second week postoperatively
second week postoperative
SDQ Questionnaire score postoperatively
Time Frame: fourth week postoperative
child's SDQ score fourth week postoperatively
fourth week postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative pain Level (by VAS)
Time Frame: in the first postoperative week (3 times a day)
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)
Time Frame: in the first postoperative week (3 times a day)
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
Time Frame: in the first postoperative week
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
Time Frame: in the first and second postoperative day
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
Time Frame: in the first and second postoperative day
Nausea and Vomiting are recognized in frequency and time using a questionnaire.
in the first and second postoperative day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Philipp Buehler, MD, University children hosptial Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2018

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

October 13, 2016

First Submitted That Met QC Criteria

October 24, 2016

First Posted (Estimate)

October 26, 2016

Study Record Updates

Last Update Posted (Actual)

February 2, 2021

Last Update Submitted That Met QC Criteria

February 1, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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