Emergence DeliriumAnaPedNCT04291820
Impact of Anaesthesiology Management on Paediatric Emergence Delirium Incidence
A study testing Intravenous induction and desflurane anaesthesia maintenance and Inhalation induction with sevoflurane and anaesthesia maintenance with sevoflurane in people with Emergence Delirium, run by Brno University Hospital at 1 site in Czechia.
Trial summary
Postoperative emergence delirium (ED) is a severe postoperative complication in paediatric anaesthesia. ED is defined as a state with psychomotor disturbance, perception disorder and state of excitation and anxiety. The incidence of ED in paediatric patients can be up to 80%. Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Emergence Delirium
- What is being tested?
- Intravenous induction and desflurane anaesthesia maintenance and Inhalation induction with sevoflurane and anaesthesia maintenance with sevoflurane
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Sep 2023to 31 Dec 2023
- Phase
- Interventional
- 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 2 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age between 2-10 years
- signed informed consent
- paediatric patient for elective adenoidectomy, or adenoidectomy with micro-otoscopy and/or frenulum discission
Who cannot join
- allergy and hypersensitivity on local anaesthetics in EMLA patch, general anaesthetics, or soya beans or peanuts
- venepuncture refusal · neuromuscular disorder with the contraindication of inhalation anaesthetics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anaesthesiology Management and the Impact on Emergenece Delirium Incidence in Paediatric Patients Undergoing Adenoidectomy or Adenoidectomy With Frenulum Dicsision a/or Microotoscopy: Randomized Controlled Trial
Postoperative emergence delirium (ED) is a severe postoperative complication in paediatric anaesthesia. ED is defined as a state with psychomotor disturbance, perception disorder and state of excitation and anxiety. The incidence of ED in paediatric patients can be up to 80%. ED is associated with the increased morbidity of paediatric patients in the postoperative period. One of the potential triggers of ED is sevoflurane. Currently, there are only limited data about comparing the influence of anesthesiologic management on the ED incidence. The possible ED reduction could lead to reduced stay in a post-anaesthesia care unit (PACU), postoperative nausea and vomiting (PONV) incidence and the overall reduction of the postoperative adverse events incidence together with the higher satisfaction and the patients and the legal guardians.
Read the detailed description
This prospective randomized interventional single-blind study aims to compare the influence of the anaesthesiology management no the incidence of ED in the postoperative period in paediatric patients. Elective paediatric patients (2-10 years) scheduled for the planned adenoidectomy or adenoidectomy + micro-otoscopy/adenoidectomy + frenulum linguae discission will be included in the trial after signed informed consent form the legal guardian. In all patients, the 2 Eutectic Mixture of Local Anesthetics (EMLA) patch will be applied on the predefined skin area ( visible vein for venepuncture) between 45 minutes to 60 minutes before anaesthesia. The patients will be randomized at the operating theatre (allocation 1:1) into the experimental group (intravenous induction with propofol + opioid and anaesthesia maintenance according to this set bispectral index value with desflurane) and the control group (inhalation induction with sevoflurane mixed with air and oxygen and anaesthesia maintenance with sevoflurane). The primary aim of the study will be the incidence of ED defined by The Pediatric Anesthesia Emergence Delirium (PAED) scale, which will be measured at the , at the admission to PACU and in the 5th, 10th, 15th, 30th minute and at the moment of dismission from PACU. The secondary aim will be the time to oral intake (from the end of the surgery), the incidence of adverse events (PONV, bradycardia, hypotension), the need for concomitant medication (analgesic medication, sedative medication, antiemetic medication).
- Conditions
- Emergence Delirium
- Being tested
- Intravenous induction and desflurane anaesthesia maintenance, Inhalation induction with sevoflurane and anaesthesia maintenance with sevoflurane
- Keywords
- Delirium, Emergence delirium, Paediatric patient, Anaesthesia
- Medical subject headings
- Emergence Delirium, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous induction and desflurane anaesthesia maintenanceProcedure or surgery
Anaesthesia will be inducted with intravenous propofol + opioid and maintained with desflurane according to the BIS levels
Inhalation induction with sevoflurane and anaesthesia maintenance with sevofluraneProcedure or surgery
Anaesthesia will be inducted with sevoflurane and maintained with sevoflurane according to the BIS levels
| Study group | Role | What they receive |
|---|---|---|
| Intravenous induction with desflurane maintenance | Experimental | The EMLA patch will be removed, and intravenous induction with propofol + opioid will be performed. The anaesthesia will be maintained with desflurane according to the levels of Bispectral index (BIS). Neuromuscular blockade is optional based on operator decision. Receives: Procedure: Intravenous induction and desflurane anaesthesia maintenance |
| Inhalation induction with sevoflurane,sevoflurane maintenance | Active comparator | The EMLA patch will be removed, and inhalation induction with the sevoflurane will be performed. After peripheral vein cannulation, the opioid will be administered. The neuromuscular blockade is optional based on operator decision. Anaesthesia will be maintained with sevoflurane according to the set BIS levels. Receives: Procedure: Inhalation induction with sevoflurane and anaesthesia maintenance with sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergence delirium incidence
The incidence of emergence delirium based on PAED score
Measured: postoperative period, up to 1 hour postoperatively
Secondary outcomes (3)
Time to first oral intake
The interval between the end of surgery and first oral intake will be measured
Measured: postoperative period, up to 1 hour postoperatively
Adverse events incidence
The adverse events in the postoperative period will be evaluated - postoperative nausea and vomiting, bradycardia, hypotension, anxiety
Measured: postoperative period, up to 1 hour postoperatively
The need for concomitant medication in PACU
The need for concomitant medication in PACU - analgesic, sedative, antiemetic medication
Measured: postoperative period, up to 1 hour postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start1 Sep 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergence DeliriumStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective interventional single-blind randomized trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petr Štourač, MD, Brno University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04291820
- Sponsor's protocol ID
- KDAR SUP 2020
- Acronym
- AnaPed
- Status last verified
- Jul 2023
- First submitted
- 26 Feb 2020
- Last updated
- 27 Jul 2023
- 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 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anaesthesiology Management and the Impact on Emergenece Delirium Incidence in Paediatric Patients Undergoing Adenoidectomy or Adenoidectomy With Frenulum Dicsision a/or Microotoscopy: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04291820
- Acronym / sponsor ID
- AnaPed / KDAR SUP 2020
- Conditions
- Emergence Delirium
- Keywords
- Delirium, Emergence delirium, Paediatric patient, Anaesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 2 Mar 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.
Postoperative emergence delirium (ED) is a severe postoperative complication in paediatric anaesthesia. ED is defined as a state with psychomotor disturbance, perception disorder and state of excitation and anxiety. The incidence of ED in paediatric patients can be up to 80%. ED is associated with the increased morbidity of paediatric patients in the postoperative period. One of the potential triggers of ED is sevoflurane. Currently, there are only limited data about comparing the influence of anesthesiologic management on the ED incidence. The possible ED reduction could lead to reduced stay in a post-anaesthesia care unit (PACU), postoperative nausea and vomiting (PONV) incidence and the overall reduction of the postoperative adverse events incidence together with the higher satisfaction and the patients and the legal guardians.
Detailed description
This prospective randomized interventional single-blind study aims to compare the influence of the anaesthesiology management no the incidence of ED in the postoperative period in paediatric patients. Elective paediatric patients (2-10 years) scheduled for the planned adenoidectomy or adenoidectomy + micro-otoscopy/adenoidectomy + frenulum linguae discission will be included in the trial after signed informed consent form the legal guardian. In all patients, the 2 Eutectic Mixture of Local Anesthetics (EMLA) patch will be applied on the predefined skin area ( visible vein for venepuncture) between 45 minutes to 60 minutes before anaesthesia. The patients will be randomized at the operating theatre (allocation 1:1) into the experimental group (intravenous induction with propofol + opioid and anaesthesia maintenance according to this set bispectral index value with desflurane) and the control group (inhalation induction with sevoflurane mixed with air and oxygen and anaesthesia maintenance with sevoflurane). The primary aim of the study will be the incidence of ED defined by The Pediatric Anesthesia Emergence Delirium (PAED) scale, which will be measured at the , at the admission to PACU and in the 5th, 10th, 15th, 30th minute and at the moment of dismission from PACU. The secondary aim will be the time to oral intake (from the end of the surgery), the incidence of adverse events (PONV, bradycardia, hypotension), the need for concomitant medication (analgesic medication, sedative medication, antiemetic medication).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective interventional single-blind randomized trial
| Arm | Type | Receives |
|---|---|---|
| Intravenous induction with desflurane maintenance | Experimental | Procedure: Intravenous induction and desflurane anaesthesia maintenanceThe EMLA patch will be removed, and intravenous induction with propofol + opioid will be performed. The anaesthesia will be maintained with desflurane according to the levels of Bispectral index (BIS). Neuromuscular blockade is optional based on operator decision. |
| Inhalation induction with sevoflurane,sevoflurane maintenance | Active comparator | Procedure: Inhalation induction with sevoflurane and anaesthesia maintenance with sevofluraneThe EMLA patch will be removed, and inhalation induction with the sevoflurane will be performed. After peripheral vein cannulation, the opioid will be administered. The neuromuscular blockade is optional based on operator decision. Anaesthesia will be maintained with sevoflurane according to the set BIS levels. |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- age between 2-10 years
- signed informed consent
- paediatric patient for elective adenoidectomy, or adenoidectomy with micro-otoscopy and/or frenulum discission
Key exclusion criteria (2 listed)
- allergy and hypersensitivity on local anaesthetics in EMLA patch, general anaesthetics, or soya beans or peanuts
- venepuncture refusal · neuromuscular disorder with the contraindication of inhalation anaesthetics
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 |
|---|---|---|
| Intravenous induction and desflurane anaesthesia maintenanceAnaesthesia will be inducted with intravenous propofol + opioid and maintained with desflurane according to the BIS levels | Procedure or surgery | Intravenous induction with desflurane maintenance |
| Inhalation induction with sevoflurane and anaesthesia maintenance with sevofluraneAnaesthesia will be inducted with sevoflurane and maintained with sevoflurane according to the BIS levels | Procedure or surgery | Inhalation induction with sevoflurane,sevoflurane maintenance |
Primary outcome
Emergence delirium incidence
Time frame: postoperative period, up to 1 hour postoperatively
The incidence of emergence delirium based on PAED score
3 secondary outcomes
Time to first oral intake
Time frame: postoperative period, up to 1 hour postoperatively
Adverse events incidence
Time frame: postoperative period, up to 1 hour postoperatively
The need for concomitant medication in PACU
Time frame: postoperative period, up to 1 hour postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravenous induction and desflurane anaesthesia maintenance and Inhalation induction with sevoflurane and anaesthesia maintenance with sevoflurane in people with Emergence Delirium, 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 27 Jul 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Petr Stourac, assoc.Prof.MD.Ph.D (5 3223 4261 ext. 00420, stourac.petr@fnbrno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emergence delirium incidence (time frame: postoperative period, up to 1 hour postoperatively). 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 27 Jul 2023.