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

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ClinicalTrials.gov Identifier: NCT02945072
Recruitment Status : Recruiting
First Posted : October 26, 2016
Last Update Posted : January 24, 2018
Sponsor:
Information provided by (Responsible Party):
University Children's Hospital, Zurich

Brief 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)

Condition or disease Intervention/treatment Phase
Child Behavior Problem Behavior Procedure: TIVA Procedure: Sevoflurane Phase 4

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  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Screening
Official Title: Postoperative Behavior in Children: A Comparison of Inhalation Anesthesia (Sevoflurane) Versus Total Intravenous Anesthesia (TIVA)
Actual Study Start Date : January 22, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
Drug Information available for: Sevoflurane

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)




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   2 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02945072


Contacts
Contact: Philipp Buehler, MD +41 44 266 32 44 philipp.buehler@kispi.uzh.ch
Contact: Achim Schmitz, MD +41 44 266 71 04 achim.schmitz@kispi.uzh.ch

Locations
Switzerland
Dr. Philipp Buehler Recruiting
Zurich, Switzerland, 8032
Contact: Achim Schmitz, MD    +41 44 266 7104    achim.schmitz@kispi.uzh.ch   
Contact: Carola Sabandal    +41 44 266 32 44    carola.sabandal@kispi.uzh.ch   
Sponsors and Collaborators
University Children's Hospital, Zurich
Investigators
Study Chair: Philipp Buehler, MD University children hosptial Zurich

Responsible Party: University Children's Hospital, Zurich
ClinicalTrials.gov Identifier: NCT02945072     History of Changes
Other Study ID Numbers: KEK-ZH-Nr. 2011-0009
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Children's Hospital, Zurich:
Child Behavior
Problem Behavior
postoperative behaviour problems

Additional relevant MeSH terms:
Problem Behavior
Behavioral Symptoms
Anesthetics
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General