Induration
Duration of Inhalation Versus Intravenous Anaesthesia Induction in Paediatric Patients: Prospective Observational Trial
Sponsor study identifier
observational
1,000
1 country
1
Study Start
October 1, 2020
Actual (reported)Primary Completion
February 28, 2022
Actual (reported)Study Completion
February 28, 2022
Actual (reported)Intravenous anaesthesia induction is nowadays considered as gold standard, mainly because of the possibility of the rapid therapeutic intervention while having secured i.v. line. In the paediatric patients, apart from intravenous induction, it is also possible to use in the specific situations inhalation anaesthesia induction with sevoflurane (in the mixture with O2 + air, or O2 + N2O) and secure the i.v. line afterwards in the inhalation anaesthesia. This method is in the paediatric population currently preferred, mainly because of possible fear of the painful venipuncture. Inhalation anaesthesia induction is possible only in patients without the risk of aspiration/regurgitation of stomach content and in patients without predicted difficult airway. Even if sedative premedication is used, during the inhalation induction excitation stage of the general anaesthesia variably appears, during which hemodynamic sympathoadrenal response and involuntary limbs movement might occur. When deepening inhalation anaesthesia, progression to surgical stage and automatic breathing onset appears. This subsequently facilitates to secure the venous access, without which is is not possible to secure the airway (in exception of the emergency situations - resuscitation).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 28, 2022
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 21, 2020
Actual (reported)August 27, 2020
Actual (reported)October 1, 2020
Actual (reported)February 28, 2022
Actual (reported)February 28, 2022
Actual (reported)duration of anaesthesia induction
The average duration of inhalation and intravenous anaesthesia induction will be measured, defined as the time since the beginning of monitoring of the vital functions (ECG, pulse oximetry, non-invasive blood pressure measurement) until the first ETCO2 wave.
Intraoperatively
The number of attempts needed to secure i.v. line
Intraoperatively
success rate of securing the i.v. line while using EMLA patch and/or Buzzy
Intraoperatively
Airway management
Intraoperatively
incidence of adverse events
Intraoperatively
Type of premedication
Intraoperatively
The measurement will begin after the patient's arrival at the operating theatre, after the control of the documentation and beginning of the vital signs monitoring. The measurement will be terminated at the occurence of the first ETCO2 wave, after securing the airway with laryngeal mask or orotracheal intubation. For the inhalation induction sevoflurane will be used (in the mixture with O2 + air, or O2 + N2O).
The measurement will begin after the patient's arrival at the operating theatre, after the control of the documentation and beginning of the vital signs monitoring. The measurement will be terminated at the occurence of the first ETCO2 wave, after securing the airway with laryngeal mask or orotracheal intubation. For the inhalation induction sevoflurane will be used (in the mixture with O2 + air, or O2 + N2O). For the intravenous induction, commonly used induction anaesthetics will be used (propofol, etomidate, ketamine, midazolam).
For the inhalation induction sevoflurane will be used (in the mixture with O2 + air, or O2 + N2O).
For the intravenous induction, commonly used induction anaesthetics will be used (propofol, etomidate, ketamine, midazolam).
Pediatric patients scheduled for elective surgical or diagnostic procedure in the term from 10.9.2020 until 30.6.2021.
University Hospital Brno
Brno, 62500, Czechia
Petr Štourač, prof. MD., Ph.D.
Faculty of medicince Masaryk University and University Hospital Brno
1,000 participants (actual enrollment reported by the registry).
First Submitted
August 21, 2020
First Posted
August 27, 2020
Study Start
October 1, 2020
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
February 28, 2022
Actual (reported)Study Completion
February 28, 2022
Actual (reported)Last Updated
March 2, 2022
Record last verified: 2022-02
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Source: ClinicalTrials.gov.
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