Duration of Anaesthesia Induction in Paediatric Patients: Prospective Observational Trial

Completed

• Conditions: Anaesthesia Induction
• Interventions: Procedure: Intravenous induction; Procedure: Inhalation induction

• Registration Number: NCT04527757
• Lead Sponsor: Brno University Hospital

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 Timeline

• Study First Submitted: 2020-08-21
• Study First Submitted QC: 2020-08-25
• Study First Posted: 2020-08-27
• Study Start: 2020-10-01
• Status Verified: 2022-02
• Primary Completion: 2022-02-28
• Study Completion: 2022-02-28
• Last Update Submitted: 2022-02-28
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Paediatric patients with intravenous induction	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).
Paediatric patients with inhalation induction	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).

Primary Outcome Measures

Name	Time	Method
duration of anaesthesia induction	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.

Secondary Outcome Measures

Name	Time	Method
The number of attempts needed to secure i.v. line	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	Intraoperatively	success rate of securing the i.v. line while using EMLA patch and/or Buzzy will be measured
Type of premedication	Intraoperatively	type of the sedative premedication
Airway management	Intraoperatively	The number of attempts needed to secure the airway will be measured
Dose of premedication	Intraoperatively	dose of the sedative premedication
incidence of adverse events	Intraoperatively	incidence of adverse events which might occur during anaesthesia induction (tachycardia, bradycardia, bronchospasm, laryngospasm)

Trial Locations

Locations (1)

University Hospital Brno; 🇨🇿 Brno, Czechia