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Duration of Anaesthesia Induction in Paediatric Patients: Prospective Observational Trial (Induration)

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ClinicalTrials.gov Identifier: NCT04527757
Recruitment Status : Recruiting
First Posted : August 27, 2020
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
Petr Štourač, MD, Brno University Hospital

Tracking Information
First Submitted Date August 21, 2020
First Posted Date August 27, 2020
Last Update Posted Date October 5, 2020
Actual Study Start Date October 1, 2020
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 25, 2020)
duration of anaesthesia induction [ Time Frame: Intraoperatively ]
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 25, 2020)
  • The number of attempts needed to secure i.v. line [ Time Frame: Intraoperatively ]
    The number of attempts needed to secure i.v. line will be measured
  • success rate of securing the i.v. line while using EMLA patch and/or Buzzy [ Time Frame: Intraoperatively ]
    success rate of securing the i.v. line while using EMLA patch and/or Buzzy will be measured
  • Airway management [ Time Frame: Intraoperatively ]
    The number of attempts needed to secure the airway will be measured
  • incidence of adverse events [ Time Frame: Intraoperatively ]
    incidence of adverse events which might occur during anaesthesia induction (tachycardia, bradycardia, bronchospasm, laryngospasm)
  • Type of premedication [ Time Frame: Intraoperatively ]
    type of the sedative premedication
  • Dose of premedication [ Time Frame: Intraoperatively ]
    dose of the sedative premedication
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Duration of Anaesthesia Induction in Paediatric Patients: Prospective Observational Trial
Official Title Duration of Inhalation Versus Intravenous Anaesthesia Induction in Paediatric Patients: Prospective Observational Trial
Brief Summary

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).

Detailed Description

The aim of this prospective observational trial is to compare the duration of inhalation and intravenous anaesthesia induction in paediatric patients, who undergo elective surgical or diagnostic procedures. After the approval of the study by the Ethics Committee of the University hospital Brno and registration of the protocol at clinicaltrials.gov, the duration of inhalation and intravenous anaesthesia induction in the patients undergoing general anaesthesia in the Departement of paediatric anaesthesia and intensive care unit, University Hospital Brno in the term from 1.9.2020 until 30.6.2021 will be measured. Measurement will be done in all patients in the given time period, who will undergo elective surgical or diagnostic procedure. 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 end-tidal carbon dioxide (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).

The type and the dose of the induction anaesthetic agent will be recorded (in the case of inhalation induction the dose of inhalation anaesthetic set on the vaporizer, in the case of intravenous induction the dose in mg/kg body weight).

The type and dose of the sedative premedication will be recorded, the number of attempts needed to secure i.v. line, success rate of securing the i.v. line while using Eutectic Mixture of Local Anesthetics (EMLA) patch and/or Buzzy (vibration device for patient distraction), the number of attempts needed to secure the airway, incidence of adverse events which might occur during anaesthesia induction (tachycardia, bradycardia, bronchospasm, laryngospasm).

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Pediatric patients scheduled for elective surgical or diagnostic procedure in the term from 10.9.2020 until 30.6.2021.
Condition Anaesthesia Induction
Intervention
  • Procedure: Inhalation induction
    For the inhalation induction sevoflurane will be used (in the mixture with O2 + air, or O2 + N2O).
    Other Name: Anaesthesia inhalation induction
  • Procedure: Intravenous induction
    For the intravenous induction, commonly used induction anaesthetics will be used (propofol, etomidate, ketamine, midazolam).
    Other Name: Anaesthesia intravenous induction
Study Groups/Cohorts
  • Paediatric patients with inhalation induction
    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).
    Intervention: Procedure: Inhalation induction
  • Paediatric patients with intravenous induction
    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).
    Intervention: Procedure: Intravenous induction
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 25, 2020)
5000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • paediatric patients scheduled for elective surgical or diagnostic procedure in the term from 10.9.2020 until 30.6.2021.

Exclusion Criteria:

  • Patients in the age from 0 to 1 month
  • patients with predicted difficult airway
  • emergency/urgent surgeries
  • patients at the risk of regurgitation/aspiration of the stomach content
  • procedures in which the airway will not be secured with laryngeal mask or orotracheal intubation
  • cases were the time of induction can not be measured
  • patients with intravenous line in situ
Sex/Gender
Sexes Eligible for Study: All
Ages up to 19 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Jozef Klučka, assoc.prof.MD., Ph.D. +420532234696 klucka.jozef@fnbrno.cz
Contact: Eva Klabusayova, MD. +420532234693 klbusayova.eva@fnbrno.cz
Listed Location Countries Czechia
Removed Location Countries  
 
Administrative Information
NCT Number NCT04527757
Other Study ID Numbers KDAR FN Brno 2020/09
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Petr Štourač, MD, Brno University Hospital
Study Sponsor Brno University Hospital
Collaborators Not Provided
Investigators
Study Chair: Petr Štourač, prof. MD., Ph.D. Faculty of medicince Masaryk University and University Hospital Brno
PRS Account Brno University Hospital
Verification Date October 2020