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

Duration of Inhalation Versus Intravenous Anaesthesia Induction in Paediatric Patients: Prospective Observational Trial

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).

Study Overview

• Status: Completed
• Conditions: Anaesthesia Induction
• Intervention / Treatment: Procedure: Inhalation induction; Procedure: Intravenous induction

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
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• Czechia
  • Brno, Czechia, 62500
    • University Hospital Brno

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 15 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).	Procedure: Inhalation induction; For the inhalation induction sevoflurane will be used (in the mixture with O2 + air, or O2 + N2O).; Other Names: Anaesthesia 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).	Procedure: Intravenous induction; For the intravenous induction, commonly used induction anaesthetics will be used (propofol, etomidate, ketamine, midazolam).; Other Names: Anaesthesia intravenous induction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Brno University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: August 21, 2020
• First Submitted That Met QC Criteria: August 25, 2020
• First Posted (Actual): August 27, 2020

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 28, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Inhalation; Anaesthesia; Intravenous; Paediatric
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: KDAR FN Brno 2020/09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No