Postoperative DeliriumNCT06571890
Emergence Agitation in Paediatric Day Care Surgery
A study testing Narcotrend bispectral index anaesthesia monitor and Mdoloris Anaesthesia Nociception Monitor in people with Postoperative Delirium and Postoperative Agitation, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
Emergence agitation is a significant and persistent challenge in paediatric anaesthesia, especially in children of preschool age. In this study, the investigators examined whether anaesthesia titration with either a sleep depth monitor or a pain monitor would result in changed postoperative agitation rates, measured… Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Postoperative Delirium, Postoperative Agitation, Anesthesia
- What is being tested?
- Narcotrend bispectral index anaesthesia monitor and Mdoloris Anaesthesia Nociception Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteDenmark
- Study dates
- 29 Mar 2019to 30 Sep 2020
- 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 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Day surgery for abdominal and urological procedures
- Children 1-6 years
- American Society of Anesthesiologist (ASA) scale 1- 2
- Airway management with laryngeal masks or facemasks
- Consent from both parents/legal representatives
- Rescue propofol is allowed
Who cannot join
- Age less than 1 or older than 6 years
- ASA > 2
- Endotracheal intubation;
- Lack of consent from both parents/legal representatives
- Daily intake of medications that interfered with the autonomic nervous system reactivity, for example, inhaled beta-agonists for bronchial asthma and total intravenous anaesthesia (TIVA).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Emergence Agitation in Paediatric Day Care Surgery: A Randomised, Single-blinded Study Comparing Narcotrend and Heart Rate Variability With Standard Monitoring
Emergence agitation is a significant and persistent challenge in paediatric anaesthesia, especially in children of preschool age.
In this study, the investigators examined whether anaesthesia titration with either a sleep depth monitor or a pain monitor would result in changed postoperative agitation rates, measured via the Richmond Agitation and Sedation Score (RASS).
93 children participated. The participants were divided into three groups: A conventional anaesthesia group, an EEG (Electroencephalography)- monitored and a pain-monitored group. The pain-monitored children received the most pain medication but were discharged at the same rate as the other children with unchanged rates of nausea and vomiting and less agitation than the sleep-monitored children.
Read the detailed description
Healthy preschool outpatients assigned for abdominal/inguinal hernia and cryptorchidism repairs participated after parental consent.
One group received standard anaesthesia induction and maintenance, according to the usual ward regimen. This was done with sevoflurane inhalation, fentanyl bolus and a laryngeal mask airway (Standard group, STD group)
The second group received standard anaesthesia as well only this time the sevoflurane titration was guided via the Nacotrend bispectral index monitor, towards a narcotrend index of 2-4. (Narcotrend group, NCT group)
The third group also received standard anaesthesia and was additionally monitored with a Mdoloris Anaesthesia Nociception Index (ANI) monitor for perioperative nociception. When a nociceptive threshold was exceeded, an extra bolus of fentanyl of 1 mcg/kg was given (ANI group)
All children were then escorted to the postoperative care unit for wakeup. A Richmond Agitation Sedation Scale score (RASS-score) was made every 15 minutes until discharge. This was analysed with Kaplan-Meyer mortality graph, along with usual statistics of secondary outcomes.
The children in the ANI group received the least fentanyl and were discharged no later than all the other children.
- Conditions
- Postoperative Delirium, Postoperative Agitation, Anesthesia, Pain Monitoring, Heart Rate Variability, Narcotrend
- Being tested
- Narcotrend bispectral index anaesthesia monitor, Mdoloris Anaesthesia Nociception Monitor
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narcotrend bispectral index anaesthesia monitorDevice
A bispectral index anaesthesia monitor collects simplified EEG via forehead electrodes and displays an index of 0-100, where an index of 40-60 is considered optimal
Mdoloris Anaesthesia Nociception MonitorDevice
A heart rate variability-based nociception monitor collects ECG-signal from electrodes on the patient's chest and displays an index of 0-100 where an index below 50 is considered nociceptive.
| Study group | Role | What they receive |
|---|---|---|
| Standard (STD) | No intervention | Standard anaesthesia with Sevoflurane Inhalation anaesthesia, fentanyl and a laryngeal mask |
| Narcotrend (NCT) | Experimental | Standard anaesthesia with Sevoflurane inhalation anaesthesia, fentanyl and a laryngeal mask. Sevoflurane concentration was titrated via a Narcotrend bispectral anaesthesia monitor. Receives: Device: Narcotrend bispectral index anaesthesia monitor |
| Anaesthesia Nociception Index Monitor (ANI) | Experimental | Standard anaesthesia with Sevoflurane inhalation anaesthesia, fentanyl and a laryngeal mask. Fentanyl dosage titrated with guidance from Mdoloris ANI monitor, a heart rate variability-based nociception monitor. When a threshold value is exceeded, additional fentanyl 1 mcg/kg is given Receives: Device: Mdoloris Anaesthesia Nociception Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Richmond Agitation Sedation Scale Score
Scoring system for sedation and agitation from -5 til +4.
Measured: During postoperative care unit (PACU) stay within 0-8 hours
Secondary outcomes (5)
Time consumption
Time spent with anesthesia, PACU stay and total time.
Measured: Within 48 hours of hospital admission
Fentanyl consumption
Given during the anesthesia against postoperative pain
Measured: Within 48 hours of hospital admission
Nurse-VAS
A Visual-Analogue-Scale score (VAS score) assessed by PACU nurses. A score from 0-10 where 10 represents worst pain.
Measured: Within the duration of PACU stay of 0-8 hours
PONV
Postoperative nausea and vomiting (PONV). A score from 0-2 where 2 represents worst nausea and vomiting.
Measured: Within the duration of PACU stay of 0-8 hours
Other medications
Other drugs, such as NSAIDs, given
Measured: During the first 24 postoperative hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start29 Mar 2019
- Primary completion12 Jun 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Odense Patient Data Explorative Network
- Responsible party
- Sponsor
- Investigators
- Line Gry Larsen, Principal investigator, Anaeshtesiologic Intensive Ward V, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06571890
- Sponsor's protocol ID
- 280482
- Status last verified
- Aug 2024
- First submitted
- 2 Apr 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergence Agitation in Paediatric Day Care Surgery: A Randomised, Single-blinded Study Comparing Narcotrend and Heart Rate Variability With Standard Monitoring
- ClinicalTrials.gov ID
- NCT06571890
- Acronym / sponsor ID
- 280482
- Conditions
- Postoperative Delirium, Postoperative Agitation, Anesthesia, Pain Monitoring, Heart Rate Variability, Narcotrend
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Odense Patient Data Explorative Network
- Study start
- 29 Mar 2019 (actual)
- Primary completion
- 12 Jun 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 26 Aug 2024 (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 agitation is a significant and persistent challenge in paediatric anaesthesia, especially in children of preschool age.
In this study, the investigators examined whether anaesthesia titration with either a sleep depth monitor or a pain monitor would result in changed postoperative agitation rates, measured via the Richmond Agitation and Sedation Score (RASS).
93 children participated. The participants were divided into three groups: A conventional anaesthesia group, an EEG (Electroencephalography)- monitored and a pain-monitored group. The pain-monitored children received the most pain medication but were discharged at the same rate as the other children with unchanged rates of nausea and vomiting and less agitation than the sleep-monitored children.
Detailed description
Healthy preschool outpatients assigned for abdominal/inguinal hernia and cryptorchidism repairs participated after parental consent.
One group received standard anaesthesia induction and maintenance, according to the usual ward regimen. This was done with sevoflurane inhalation, fentanyl bolus and a laryngeal mask airway (Standard group, STD group)
The second group received standard anaesthesia as well only this time the sevoflurane titration was guided via the Nacotrend bispectral index monitor, towards a narcotrend index of 2-4. (Narcotrend group, NCT group)
The third group also received standard anaesthesia and was additionally monitored with a Mdoloris Anaesthesia Nociception Index (ANI) monitor for perioperative nociception. When a nociceptive threshold was exceeded, an extra bolus of fentanyl of 1 mcg/kg was given (ANI group)
All children were then escorted to the postoperative care unit for wakeup. A Richmond Agitation Sedation Scale score (RASS-score) was made every 15 minutes until discharge. This was analysed with Kaplan-Meyer mortality graph, along with usual statistics of secondary outcomes.
The children in the ANI group received the least fentanyl and were discharged no later than all the other children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard (STD) | No intervention | –Standard anaesthesia with Sevoflurane Inhalation anaesthesia, fentanyl and a laryngeal mask |
| Narcotrend (NCT) | Experimental | Device: Narcotrend bispectral index anaesthesia monitorStandard anaesthesia with Sevoflurane inhalation anaesthesia, fentanyl and a laryngeal mask. Sevoflurane concentration was titrated via a Narcotrend bispectral anaesthesia monitor. |
| Anaesthesia Nociception Index Monitor (ANI) | Experimental | Device: Mdoloris Anaesthesia Nociception MonitorStandard anaesthesia with Sevoflurane inhalation anaesthesia, fentanyl and a laryngeal mask. Fentanyl dosage titrated with guidance from Mdoloris ANI monitor, a heart rate variability-based nociception monitor. When a threshold value is exceeded, additional fentanyl 1 mcg/kg is given |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Day surgery for abdominal and urological procedures
- Children 1-6 years
- American Society of Anesthesiologist (ASA) scale 1- 2
- Airway management with laryngeal masks or facemasks
- Consent from both parents/legal representatives
Key exclusion criteria (5 listed)
- Age less than 1 or older than 6 years
- ASA > 2
- Endotracheal intubation;
- Lack of consent from both parents/legal representatives
- Daily intake of medications that interfered with the autonomic nervous system reactivity, for example, inhaled beta-agonists for bronchial asthma and total intravenous anaesthesia (TIVA).
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 |
|---|---|---|
| Narcotrend bispectral index anaesthesia monitorA bispectral index anaesthesia monitor collects simplified EEG via forehead electrodes and displays an index of 0-100, where an index of 40-60 is considered optimal | Device | Narcotrend (NCT) |
| Mdoloris Anaesthesia Nociception MonitorA heart rate variability-based nociception monitor collects ECG-signal from electrodes on the patient's chest and displays an index of 0-100 where an index below 50 is considered nociceptive. | Device | Anaesthesia Nociception Index Monitor (ANI) |
Primary outcome
Richmond Agitation Sedation Scale Score
Time frame: During postoperative care unit (PACU) stay within 0-8 hours
Scoring system for sedation and agitation from -5 til +4.
5 secondary outcomes
Time consumption
Time frame: Within 48 hours of hospital admission
Fentanyl consumption
Time frame: Within 48 hours of hospital admission
Nurse-VAS
Time frame: Within the duration of PACU stay of 0-8 hours
PONV
Time frame: Within the duration of PACU stay of 0-8 hours
Other medications
Time frame: During the first 24 postoperative hours
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 26 Aug 2024.
- Individual participant dataSharing planned: No
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The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
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Lactium Premedication to Prevent Emergence Agitation
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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.
Line Gry Larsen principal investigator
Anaeshtesiologic Intensive Ward V, Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Narcotrend bispectral index anaesthesia monitor and Mdoloris Anaesthesia Nociception Monitor in people with Postoperative Delirium and Postoperative Agitation, run by University of Southern Denmark at 1 site in Denmark.
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 6 inclusion and 5 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 26 Aug 2024. 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 Denmark. 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?
Richmond Agitation Sedation Scale Score (time frame: During postoperative care unit (PACU) stay within 0-8 hours). 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 26 Aug 2024.