NCT02945072

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2018

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 26, 2016

Completed
1.2 years until next milestone

Study Start

First participant enrolled

January 22, 2018

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2024

Completed
Last Updated

December 19, 2024

Status Verified

December 1, 2024

Enrollment Period

6.4 years

First QC Date

October 13, 2016

Last Update Submit

December 16, 2024

Conditions

Child BehaviorProblem Behavior

Keywords

Child BehaviorProblem Behaviorpostoperative behaviour problems

Outcome Measures

Primary Outcomes (6)

  • Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively

    child's PHBQ score first week postoperatively

    first week postoperative

  • Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively

    child's PHBQ score second week postoperatively

    second week postoperative

  • Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively

    child's PHBQ score fourth week postoperatively

    fourth week postoperative

  • SDQ Questionnaire score postoperatively

    child's SDQ score first week postoperatively

    first week postoperative

  • SDQ Questionnaire score postoperatively

    child's SDQ score second week postoperatively

    second week postoperative

  • SDQ Questionnaire score postoperatively

    child's SDQ score fourth week postoperatively

    fourth week postoperative

Secondary Outcomes (5)

  • postoperative pain Level (by VAS)

    in the first postoperative week (3 times a day)

  • postoperative pain Level (by CHEOPS)

    in the first postoperative week (3 times a day)

  • postoperative pain medication

    in the first postoperative week

  • Intraoperative awareness

    in the first and second postoperative day

  • postoperative Nausea and vomiting

    in the first and second postoperative day

Study Arms (2)

Sevoflurane group

ACTIVE COMPARATOR

general anesthesia will be maintained with sevoflurane

Procedure: Sevoflurane

TIVA group

EXPERIMENTAL

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

Procedure: TIVA

Interventions

TIVAPROCEDURE

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)

TIVA group
SevofluranePROCEDURE

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

Sevoflurane group

Eligibility Criteria

Age2 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Philipp Buehler

Zurich, 8032, Switzerland

Location

MeSH Terms

Conditions

Child BehaviorProblem Behavior

Interventions

Sevoflurane

Condition Hierarchy (Ancestors)

BehaviorBehavioral Symptoms

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbons

Study Officials

  • Philipp Buehler, MD

    University children hosptial Zurich

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2016

First Posted

October 26, 2016

Study Start

January 22, 2018

Primary Completion

June 4, 2024

Study Completion

June 4, 2024

Last Updated

December 19, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)