Anaesthesia InductionIndurationNCT04527757
Duration of Anaesthesia Induction in Paediatric Patients: Prospective Observational Trial
An observational study of Anaesthesia Induction, run by Brno University Hospital at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 28 days to 19 years
- Conditions the study is for
- Anaesthesia Induction
- What is being tested?
- Inhalation induction and Intravenous induction
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Oct 2020to 28 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 days to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients scheduled for elective surgical or diagnostic procedure in the term from 10.9.2020 until 30.6.2021.
Who may be able to join
- paediatric patients scheduled for elective surgical or diagnostic procedure in the term from 10.9.2020 until 30.6.2021.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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).
- Conditions
- Anaesthesia Induction
- Being tested
- Inhalation induction, Intravenous induction
- Keywords
- Anaesthesia, Paediatric, Inhalation, Intravenous
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhalation inductionProcedure or surgery
Also called Anaesthesia inhalation induction
For the inhalation induction sevoflurane will be used (in the mixture with O2 + air, or O2 + N2O).
Intravenous inductionProcedure or surgery
Also called Anaesthesia intravenous induction
For the intravenous induction, commonly used induction anaesthetics will be used (propofol, etomidate, ketamine, midazolam).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Procedure: Intravenous induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intraoperatively
Secondary outcomes (6)
The number of attempts needed to secure i.v. line
The number of attempts needed to secure i.v. line will be measured
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
Measured: Intraoperatively
Airway management
The number of attempts needed to secure the airway will be measured
Measured: Intraoperatively
incidence of adverse events
incidence of adverse events which might occur during anaesthesia induction (tachycardia, bradycardia, bronchospasm, laryngospasm)
Measured: Intraoperatively
Type of premedication
type of the sedative premedication
Measured: Intraoperatively
Dose of premedication
dose of the sedative premedication
Measured: Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start1 Oct 2020
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anaesthesia InductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petr Štourač, MD, Brno University Hospital
- Investigators
- Petr Štourač, prof. MD., Ph.D., Study chair, Faculty of medicince Masaryk University and University Hospital Brno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04527757
- Sponsor's protocol ID
- KDAR FN Brno 2020/09
- Acronym
- Induration
- Status last verified
- Feb 2022
- First submitted
- 21 Aug 2020
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duration of Inhalation Versus Intravenous Anaesthesia Induction in Paediatric Patients: Prospective Observational Trial
- ClinicalTrials.gov ID
- NCT04527757
- Acronym / sponsor ID
- Induration / KDAR FN Brno 2020/09
- Conditions
- Anaesthesia Induction
- Keywords
- Anaesthesia, Paediatric, Inhalation, Intravenous
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 27 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paediatric patients with inhalation induction | – | Procedure: Inhalation inductionThe 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). |
| Paediatric patients with intravenous induction | – | Procedure: Intravenous inductionThe 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). |
Who may qualify
- Ages
- 28 days to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients scheduled for elective surgical or diagnostic procedure in the term from 10.9.2020 until 30.6.2021.
Key inclusion criteria (1 listed)
- paediatric patients scheduled for elective surgical or diagnostic procedure in the term from 10.9.2020 until 30.6.2021.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhalation inductionAlso: Anaesthesia inhalation inductionFor the inhalation induction sevoflurane will be used (in the mixture with O2 + air, or O2 + N2O). | Procedure or surgery | Paediatric patients with inhalation induction |
| Intravenous inductionAlso: Anaesthesia intravenous inductionFor the intravenous induction, commonly used induction anaesthetics will be used (propofol, etomidate, ketamine, midazolam). | Procedure or surgery | Paediatric patients with intravenous induction |
Primary outcome
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.
6 secondary outcomes
The number of attempts needed to secure i.v. line
Time frame: Intraoperatively
success rate of securing the i.v. line while using EMLA patch and/or Buzzy
Time frame: Intraoperatively
Airway management
Time frame: Intraoperatively
incidence of adverse events
Time frame: Intraoperatively
Type of premedication
Time frame: Intraoperatively
Dose of premedication
Time frame: Intraoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petr Štourač, prof. MD., Ph.D. study chair
Faculty of medicince Masaryk University and University Hospital Brno
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anaesthesia Induction, run by Brno University Hospital at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration of anaesthesia induction (time frame: Intraoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.