Emergence DeliriumPACUDELNCT04531020
Incidence of Emergence Delirium in the PACU
An observational study of Emergence Delirium, run by Brno University Hospital at 1 site in Czechia.
Trial summary
Emergence delirium (ED) is serious complication in the postoperative period in paediatric anaesthesia, reported incidence is 20-60%. It is characterized by psychomotor and perception disorder with excitation of paediatric patients. Read more about this study
- Who is it for?
- Ages 1 month to 19 years
- Conditions the study is for
- Emergence Delirium
- What is being tested?
- PAED measurement
- How many people
- 1,421 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Oct 2020to 1 Jan 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 1 month to 19 years
- All sexes
- Child, Adult
Study population: Patients after general anaesthesia hospitalized in the PACU
Who may be able to join
- Patients after general anaesthesia hospitalized in the PACU in the term rom 1.9.2020 until 30.6.2021.
Who cannot join
- Patients in the age from 0 to 1 month.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence of Emergence Delirium in the PACU: Prospective Observational Trial
Emergence delirium (ED) is serious complication in the postoperative period in paediatric anaesthesia, reported incidence is 20-60%. It is characterized by psychomotor and perception disorder with excitation of paediatric patients. Emergence delirium has impact on morbidity and even on mortality of paediatric patients in the postoperative period.
The potential risk factors for ED development include sevoflurane, which is the dominant anaesthetic agent used in the paediatric patients, and which is actually the only inhalation agent used for inhalation anaesthesia induction. The incidence of ED is higher in postoperative period, for example in the Post-anaesthesia Care Unit - PACU. Patients with ED are at higher risk of psychomotor anxiety, agitation, unintentional extraction of intravenous cannula, and nausea and vomiting. For the therapy of ED propofol, midazolam and eventually ketamine in a reduced dosage are used.
Read the detailed description
After the approval of the study by the Ethics Committee of the University hospital Brno and registration of the protocol at clinicaltrials.gov, the incidence of emergence delirium (ED) using PAED, WATCHA and Richmond agitation and sedation scale (RASS) score in patients hospitalized in the post-anaesthesia care unit (PACU) after 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.
Paediatric Emergence Delirium (PAED) score, WATCHA score and Richmond agitation and sedation scale (RASS) will be measured in 0., 5., 10., 15., and 20. minute after PACU admission and after obtaining RASS ≥ - 2 . Emergence delirium is defined as PAED score above 10 points. In the case of ED development, the duration of ED will be measured as well as the number of therapeutic interventions and the cumulative dose of administered sedatives. The average PAED, WATCHA, RASS scale will be reported, the incidence of postoperative nausea and vomiting (PONV) and the cumulative dose of administered antiemetics, the type of anaesthesia induction (inhalation vs. intravenous), type of anaesthesia (TIVA, combined, inhalational), length of the surgery, type of the surgery will be reported.
- Conditions
- Emergence Delirium
- Being tested
- PAED measurement
- Keywords
- Emergence delirium, Anaesthesia, Paediatric patient
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAED measurementDiagnostic test
Also called PAED score measurement at PACU
The incidence of emergence delirium, defined as PAED score above 10 points minimally in one of the PAED score measurements. PAED score will be measured in 0., 5., 10., 15., and 20. minute after PACU admission.
| Study group | Role | What they receive |
|---|---|---|
| Patients at PACU | Patients undergoing elective surgical or diagnostic intervention admitted to PACU after postanaesthesia recovery Receives: Diagnostic Test: PAED measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of emergence delirium
The incidence of emergence delirium, defined as PAED score above 10 points and/or WATCHA score over 2 and or RASS over 1 minimally in one of the measurements. All measurements will be measured in 0., 5., 10., 15., and 20. minute after PACU admission. The first measurement (T0) will be intiated after first obtaining RASS over -2.
Measured: up to 60 minutes after PACU admission
Secondary outcomes (11)
The duration of ED
The cumulative duration of ED will be measured
Measured: up to 60 minutes after PACU admission
The average PAED score
The average PAED score at PACU will be measured
Measured: up to 60 minutes after PACU admission
The need for pharmacology intervention incidence
The need for pharmacology intervention - defined by the number of therapeutic interventions
Measured: up to 60 minutes after PACU admission
incidence of postoperative nausea and vomiting (PONV)
incidence of postoperative nausea and vomiting (PONV) defined by the cumulative dose of administered antiemetics
Measured: up to 60 minutes after PACU admission
type of anaesthesia induction (inhalation vs. intravenous)
type of anaesthesia induction (inhalation vs. intravenous) will be evaluated
Measured: up to 60 minutes after PACU admission
type of anaesthesia (TIVA, combined, inhalational)
type of anaesthesia (TIVA, combined, inhalational) will be evaluated
Measured: up to 60 minutes after PACU admission
length of the surgery
length of the surgery will be evaluated
Measured: up to 60 minutes after PACU admission
type of the surgery
type of the surgery will be evaluated
Measured: up to 60 minutes after PACU admission
cumulative dose of administered sedatives
the cumulative dose of administered sedatives
Measured: up to 60 minutes after PACU admission
The average WATCHA score
The average WATCHA score at PACU will be measured
Measured: up to 60 minutes after PACU admission
The average RASS score
The average RASS score at PACU will be measured
Measured: up to 60 minutes after PACU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start1 Oct 2020
- Primary completion30 Jun 2021
- Study completion1 Jan 2022
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,421 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
- NCT04531020
- Sponsor's protocol ID
- KDAR FN Brno 2020/10
- Acronym
- PACUDEL
- Status last verified
- Feb 2022
- First submitted
- 21 Aug 2020
- Last updated
- 15 Feb 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 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Emergence Delirium in the PACU: Prospective Observational Trial
- ClinicalTrials.gov ID
- NCT04531020
- Acronym / sponsor ID
- PACUDEL / KDAR FN Brno 2020/10
- Conditions
- Emergence Delirium
- Keywords
- Emergence delirium, Anaesthesia, Paediatric patient
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,421 participants (actual)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 28 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.
Emergence delirium (ED) is serious complication in the postoperative period in paediatric anaesthesia, reported incidence is 20-60%. It is characterized by psychomotor and perception disorder with excitation of paediatric patients. Emergence delirium has impact on morbidity and even on mortality of paediatric patients in the postoperative period.
The potential risk factors for ED development include sevoflurane, which is the dominant anaesthetic agent used in the paediatric patients, and which is actually the only inhalation agent used for inhalation anaesthesia induction. The incidence of ED is higher in postoperative period, for example in the Post-anaesthesia Care Unit - PACU. Patients with ED are at higher risk of psychomotor anxiety, agitation, unintentional extraction of intravenous cannula, and nausea and vomiting. For the therapy of ED propofol, midazolam and eventually ketamine in a reduced dosage are used.
Detailed description
After the approval of the study by the Ethics Committee of the University hospital Brno and registration of the protocol at clinicaltrials.gov, the incidence of emergence delirium (ED) using PAED, WATCHA and Richmond agitation and sedation scale (RASS) score in patients hospitalized in the post-anaesthesia care unit (PACU) after 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.
Paediatric Emergence Delirium (PAED) score, WATCHA score and Richmond agitation and sedation scale (RASS) will be measured in 0., 5., 10., 15., and 20. minute after PACU admission and after obtaining RASS ≥ - 2 . Emergence delirium is defined as PAED score above 10 points. In the case of ED development, the duration of ED will be measured as well as the number of therapeutic interventions and the cumulative dose of administered sedatives. The average PAED, WATCHA, RASS scale will be reported, the incidence of postoperative nausea and vomiting (PONV) and the cumulative dose of administered antiemetics, the type of anaesthesia induction (inhalation vs. intravenous), type of anaesthesia (TIVA, combined, inhalational), length of the surgery, type of the surgery will be reported.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients at PACU | – | Diagnostic Test: PAED measurementPatients undergoing elective surgical or diagnostic intervention admitted to PACU after postanaesthesia recovery |
Who may qualify
- Ages
- 1 month to 19 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Patients after general anaesthesia hospitalized in the PACU
Key inclusion criteria (1 listed)
- Patients after general anaesthesia hospitalized in the PACU in the term rom 1.9.2020 until 30.6.2021.
Key exclusion criteria (1 listed)
- Patients in the age from 0 to 1 month.
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 |
|---|---|---|
| PAED measurementAlso: PAED score measurement at PACUThe incidence of emergence delirium, defined as PAED score above 10 points minimally in one of the PAED score measurements. PAED score will be measured in 0., 5., 10., 15., and 20. minute after PACU admission. | Diagnostic test | Patients at PACU |
Primary outcome
The incidence of emergence delirium
Time frame: up to 60 minutes after PACU admission
The incidence of emergence delirium, defined as PAED score above 10 points and/or WATCHA score over 2 and or RASS over 1 minimally in one of the measurements. All measurements will be measured in 0., 5., 10., 15., and 20. minute after PACU admission. The first measurement (T0) will be intiated after first obtaining RASS over -2.
11 secondary outcomes
The duration of ED
Time frame: up to 60 minutes after PACU admission
The average PAED score
Time frame: up to 60 minutes after PACU admission
The need for pharmacology intervention incidence
Time frame: up to 60 minutes after PACU admission
incidence of postoperative nausea and vomiting (PONV)
Time frame: up to 60 minutes after PACU admission
type of anaesthesia induction (inhalation vs. intravenous)
Time frame: up to 60 minutes after PACU admission
type of anaesthesia (TIVA, combined, inhalational)
Time frame: up to 60 minutes after PACU admission
length of the surgery
Time frame: up to 60 minutes after PACU admission
type of the surgery
Time frame: up to 60 minutes after PACU admission
cumulative dose of administered sedatives
Time frame: up to 60 minutes after PACU admission
The average WATCHA score
Time frame: up to 60 minutes after PACU admission
The average RASS score
Time frame: up to 60 minutes after PACU admission
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 15 Feb 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 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 1 inclusion and 1 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 15 Feb 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?
The incidence of emergence delirium (time frame: up to 60 minutes after PACU admission). 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 15 Feb 2022.