NCT05193747

Brief Summary

Perioperative measurement of the Depth of anaesthesia is currently recommended part of daily anaesthesia good clinical practice. The optimal depth of anaesthesia measured by Bispectral index could be between 40-60. The lower (over 60) depth of anaesthesia could be associated with accidental intraoperative episodes of awareness and deeper (below 40) anaesthesia could lead to higher adverse events or even haemodynamic instability.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2022

Completed
12 days until next milestone

Study Start

First participant enrolled

January 14, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 18, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 24, 2023

Status Verified

March 1, 2023

Enrollment Period

2 years

First QC Date

January 2, 2022

Last Update Submit

March 23, 2023

Conditions

Anesthesia Awareness

Keywords

AnesthesiaAwarenessPediatricChildren

Outcome Measures

Primary Outcomes (2)

  • Cumulative time outside recommended BIS levels

    The cumulative time spent outside the recommended BIS levels will be evaluated

    intraoperatively

  • Periods outside recommended BIS levels

    The incidence of periods outside the recommended anaesthesia depth will be recorded (episode is defined by ≥ 30 seconds interval outside the predefined limits, the end of episode is defined by the return to recommended BIS level).

    intraoperatively

Secondary Outcomes (5)

  • Ability to respond

    Intraoperatively

  • Incidence of emergence delirium

    2 hours postoperatively

  • Incidence of overall complications

    2 hours postoperatively

  • Delay to respond

    Intraoperatively

  • Incidence of postoperative nausea and vomiting (PONV(

    2 hours postoperatively

Study Arms (1)

Paediatric patients scheduled for general anesthesia

Paediatric patients (between 1 year -19 years) undergoing elective general anaesthesia with presumed duration over 1 hour will be eligible for inclusion

Other: Anesthesia depth monitoring

Interventions

Anesthesia depth monitoringOTHER

BIS monitor will be placed on the forehead according to the manufacturer recommendation and the anaesthesia team will be blinded to BIS monitor during the whole case. The initial BIS tracing will be recorded starting the surgery initiation (defined as the depth of anesthesia by the anaesthesiologist to initiate surgical intervention) and ending with end of surgical intervention.

Paediatric patients scheduled for general anesthesia

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Paediatric patients (between 1 year -19 years) undergoing elective general anaesthesia with presumed duration over 1 hour will be eligible for inclusion.

You may qualify if:

  • Age 1 year-19 years
  • Elective general anaesthesia with presumed duration over 60 minutes
  • BIS monitor available

You may not qualify if:

  • Outside the age limits
  • Acute surgery
  • Presumed anaesthesia duration below 1 hour
  • Without the possibility of BIS monitoring
  • Patient indicated for sedation and mechanical ventilation after anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brno University Hospital

Brno, South Moravian, 62500, Czechia

RECRUITING

MeSH Terms

Conditions

Intraoperative Awareness

Condition Hierarchy (Ancestors)

Intraoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Petr Stourac, prof. MD., Ph.D., MBA

    Department of paediatric anaesthesia and intensive care medicine

    STUDY CHAIR

Central Study Contacts

Jozef Klučka, assoc.prof.MD., Ph.D.

CONTACT

532234696klucka.jozef@fnbrno.cz

Tereza Musilová, MD

CONTACT

532234691musilova.tereza@fnrbno.cz

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

January 2, 2022

First Posted

January 18, 2022

Study Start

January 14, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

March 24, 2023

Record last verified: 2023-03

Locations

CZ(1)