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Completed

NCT Number: NCT02945072

Clinical Study of Behavior Problems in Children After Different Anesthesia Methods

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)

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Key information

Age range

2 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dr. Philipp Buehler

Zurich, 8032, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TIVA

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)

Sevoflurane

Procedure

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

Primary outcomes

  1. Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively

    Time frame: first week postoperative

    child's PHBQ score first week postoperatively

  2. Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively

    Time frame: second week postoperative

    child's PHBQ score second week postoperatively

  3. Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively

    Time frame: fourth week postoperative

    child's PHBQ score fourth week postoperatively

  4. SDQ Questionnaire score postoperatively

    Time frame: first week postoperative

    child's SDQ score first week postoperatively

  5. SDQ Questionnaire score postoperatively

    Time frame: second week postoperative

    child's SDQ score second week postoperatively

  6. SDQ Questionnaire score postoperatively

    Time frame: fourth week postoperative

    child's SDQ score fourth week postoperatively

Secondary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

University Children's Hospital, Zurich

Other

Registry information

Official study title

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

Acronym: PST

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Oct 26, 2016
Registry last updated
Dec 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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