Clinical Study of Behavior Problems in Children After Different Anesthesia Methods (PST)
Primary Purpose
Child Behavior, Problem Behavior
Status
Recruiting
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
TIVA
Sevoflurane
Sponsored by
About this trial
This is an interventional screening trial for Child Behavior focused on measuring Child Behavior, Problem Behavior, postoperative behaviour problems
Eligibility 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
Sites / Locations
- Dr. Philipp BuehlerRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Sevoflurane group
TIVA group
Arm Description
general anesthesia will be maintained with sevoflurane
general anesthesia will be maintained with total intravenous anesthesia (propofol and remifentanyl)
Outcomes
Primary Outcome Measures
Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively
child's PHBQ score first week postoperatively
Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively
child's PHBQ score second week postoperatively
Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively
child's PHBQ score fourth week postoperatively
SDQ Questionnaire score postoperatively
child's SDQ score first week postoperatively
SDQ Questionnaire score postoperatively
child's SDQ score second week postoperatively
SDQ Questionnaire score postoperatively
child's SDQ score fourth week postoperatively
Secondary Outcome Measures
postoperative pain Level (by VAS)
Visual Analog Scale for Pain (VAS Pain) were used to evaluate postoperative pain level
postoperative pain Level (by CHEOPS)
CHEOPS (Children's Hospital of Eastern Ontario Pain Scale) were used to evaluate postoperative pain level
postoperative pain medication
All pain medications are recorded during the first postoperative week.Nurses and parents recorded all substance and application times by questionnaire.
Intraoperative awareness
In order to record an intraoperative awareness, a semistructured interview is conducted with test questions.
postoperative Nausea and vomiting
Nausea and Vomiting are recognized in frequency and time using a questionnaire.
Full Information
NCT ID
NCT02945072
First Posted
October 13, 2016
Last Updated
February 1, 2021
Sponsor
University Children's Hospital, Zurich
1. Study Identification
Unique Protocol Identification Number
NCT02945072
Brief Title
Clinical Study of Behavior Problems in Children After Different Anesthesia Methods
Acronym
PST
Official Title
Postoperative Behavior in Children: A Comparison of Inhalation Anesthesia (Sevoflurane) Versus Total Intravenous Anesthesia (TIVA)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 22, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Children's Hospital, Zurich
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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)
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Behavior, Problem Behavior
Keywords
Child Behavior, Problem Behavior, postoperative behaviour problems
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sevoflurane group
Arm Type
Active Comparator
Arm Description
general anesthesia will be maintained with sevoflurane
Arm Title
TIVA group
Arm Type
Experimental
Arm Description
general anesthesia will be maintained with total intravenous anesthesia (propofol and remifentanyl)
Intervention Type
Procedure
Intervention Name(s)
TIVA
Intervention Description
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
Intervention Name(s)
Sevoflurane
Intervention Description
Sevoflurane is use to anesthesia maintenance after anesthesia induction (target et 2 Vol% in 50-70% N2O, dose adaptation as required)
Primary Outcome Measure Information:
Title
Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively
Description
child's PHBQ score first week postoperatively
Time Frame
first week postoperative
Title
Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively
Description
child's PHBQ score second week postoperatively
Time Frame
second week postoperative
Title
Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively
Description
child's PHBQ score fourth week postoperatively
Time Frame
fourth week postoperative
Title
SDQ Questionnaire score postoperatively
Description
child's SDQ score first week postoperatively
Time Frame
first week postoperative
Title
SDQ Questionnaire score postoperatively
Description
child's SDQ score second week postoperatively
Time Frame
second week postoperative
Title
SDQ Questionnaire score postoperatively
Description
child's SDQ score fourth week postoperatively
Time Frame
fourth week postoperative
Secondary Outcome Measure Information:
Title
postoperative pain Level (by VAS)
Description
Visual Analog Scale for Pain (VAS Pain) were used to evaluate postoperative pain level
Time Frame
in the first postoperative week (3 times a day)
Title
postoperative pain Level (by CHEOPS)
Description
CHEOPS (Children's Hospital of Eastern Ontario Pain Scale) were used to evaluate postoperative pain level
Time Frame
in the first postoperative week (3 times a day)
Title
postoperative pain medication
Description
All pain medications are recorded during the first postoperative week.Nurses and parents recorded all substance and application times by questionnaire.
Time Frame
in the first postoperative week
Title
Intraoperative awareness
Description
In order to record an intraoperative awareness, a semistructured interview is conducted with test questions.
Time Frame
in the first and second postoperative day
Title
postoperative Nausea and vomiting
Description
Nausea and Vomiting are recognized in frequency and time using a questionnaire.
Time Frame
in the first and second postoperative day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philipp Buehler, MD
Phone
+41 44 266 32 44
Email
philipp.buehler@kispi.uzh.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Achim Schmitz, MD
Phone
+41 44 266 71 04
Email
achim.schmitz@kispi.uzh.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philipp Buehler, MD
Organizational Affiliation
University children hosptial Zurich
Official's Role
Study Chair
Facility Information:
Facility Name
Dr. Philipp Buehler
City
Zurich
ZIP/Postal Code
8032
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Achim Schmitz, MD
Phone
+41 44 266 7104
Email
achim.schmitz@kispi.uzh.ch
First Name & Middle Initial & Last Name & Degree
Carola Sabandal
Phone
+41 44 266 32 44
Email
carola.sabandal@kispi.uzh.ch
12. IPD Sharing Statement
Plan to Share IPD
No
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Clinical Study of Behavior Problems in Children After Different Anesthesia Methods
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