Emergence DeliriumNACOSNCT04292457
Namsos Anaesthesia Children Outcome Study
A study testing Propofol and Sevoflurane in people with Emergence Delirium, run by Helse Nord-Trøndelag HF at 2 sites in Norway.
Trial summary
Behavioral disturbances are often seen in children after anesthesia both immediately after surgery (emergence delirium) and after discharge from hospital. Persisting behavioral changes may affect emotional and cognitive development. Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Emergence Delirium
- What is being tested?
- Propofol and Sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 761 participants
- Where
- 2 sitesNorway
- Study dates
- 4 Mar 2020to 6 Jan 2024
- 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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- adenotomy and/or tonsillotomy and/or tonsillectomy
- ASA physical status class I or II
Who cannot join
- unexperienced ear-nose-throat (ENT) surgeon (ENT surgeon < 1 year of training, ENT surgeon without experience with the use of laryngeal mask as airway during adenotomy/tonsillotomy/tonsillectomy)
- preoperative syndromes
- ASA physical status class > 2
- missing written consent from parents/guardians
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Namsos Hospital, Nord-Trondelag Hospital Trust
Namsos, Trøndelag, 7800
ØNH Legen
Trondheim, Trøndelag
About this study
Official title: Namsos Anaesthesia Children Outcome Study (NACOS)
Behavioral disturbances are often seen in children after anesthesia both immediately after surgery (emergence delirium) and after discharge from hospital. Persisting behavioral changes may affect emotional and cognitive development. It is known that both type of surgery and anesthetic management affect the occurrence of behavioral disturbances. Specifically, differences in occurrence were found after sevoflurane anesthesia and propofol anesthesia, two anesthetics that are generally used in practice. However, evidence is based on methodologically weak studies.
The described occurrence of behavioral disturbances in children after anesthesia is not in line with the investigators' clinical experience, and neither are the described differences in occurrence between sevoflurane anesthesia and propofol anesthesia. This study will compare emergence delirium and behavioral changes after discharge from hospital in children who had surgery for removal of their tonsils under sevoflurane anesthesia versus propofol anesthesia.
- Conditions
- Emergence Delirium
- Being tested
- Propofol, Sevoflurane
- Keywords
- Pediatric Anaesthesia, Emergence Delirium, Postoperative Behavioral Changes, Sevoflurane, Propofol, Adenotonsillectomy
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Anesthesia is maintained with a continuous infusion of Propofol. Induction of anesthesia and anesthetic management are otherwise the same in both study arms.
SevofluraneDrug
Anesthesia is maintained with a continuous inhalation of Sevoflurane. Induction of anesthesia and anesthetic management are otherwise the same in both study arms.
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Experimental | Anesthesia is maintained with Propofol Receives: Drug: Propofol |
| Sevoflurane | Experimental | Anesthesia is maintained with Sevoflurane Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Anesthesia Emergence Delirium Scale (PAED) ≥ 10
A PAED score ≥ 10 during the first hour after emergence from anaesthesia is defined as an ED event occuring
Measured: 1 hour
Secondary outcomes (3)
Face, Legs, Activity, Cry, Consolability Scale (FLACC) ≥ 4
A FLACC score ≥ 4 during the first hour after emergence from anaesthesia is defined as moderate or severe pain
Measured: 1 hour
Post Hospital Behavioral Questionnaire (PHBQ)
An average score > 3 in one or more of the questionnaire categories is defined as postoperative behavioural change
Measured: 7 days
Post Hospital Behavioral Questionnaire (PHBQ)
An average score > 3 in one or more of the questionnaire categories is defined as postoperative behavioural change
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start4 Mar 2020
- Primary completion6 Dec 2023
- Study completion6 Jan 2024
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 761 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Nord-Trøndelag HF
- Sponsor type
- University, hospital or other
- Collaborators
- ØNH Legen Trondheim, St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Hallvard Græslie, MD, Study chair, Head of surgical Clinic, Namsos Hospital, Nord-Trondelag Hospital Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04292457
- Sponsor's protocol ID
- 43654
- Acronym
- NACOS
- Status last verified
- Feb 2024
- First submitted
- 29 Feb 2020
- Last updated
- 1 Mar 2024
- Results posted
- No
- 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 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Namsos Anaesthesia Children Outcome Study (NACOS)
- ClinicalTrials.gov ID
- NCT04292457
- Acronym / sponsor ID
- NACOS / 43654
- Conditions
- Emergence Delirium
- Keywords
- Pediatric Anaesthesia, Emergence Delirium, Postoperative Behavioral Changes, Sevoflurane, Propofol, Adenotonsillectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 761 participants (actual)
- Lead sponsor
- Helse Nord-Trøndelag HFUniversity, hospital or other
- Collaborators
- ØNH Legen Trondheim, St. Olavs Hospital
- Study start
- 4 Mar 2020 (actual)
- Primary completion
- 6 Dec 2023 (actual)
- Study completion
- 6 Jan 2024 (actual)
- First posted
- 3 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.
Behavioral disturbances are often seen in children after anesthesia both immediately after surgery (emergence delirium) and after discharge from hospital. Persisting behavioral changes may affect emotional and cognitive development. It is known that both type of surgery and anesthetic management affect the occurrence of behavioral disturbances. Specifically, differences in occurrence were found after sevoflurane anesthesia and propofol anesthesia, two anesthetics that are generally used in practice. However, evidence is based on methodologically weak studies.
The described occurrence of behavioral disturbances in children after anesthesia is not in line with the investigators' clinical experience, and neither are the described differences in occurrence between sevoflurane anesthesia and propofol anesthesia. This study will compare emergence delirium and behavioral changes after discharge from hospital in children who had surgery for removal of their tonsils under sevoflurane anesthesia versus propofol anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol | Experimental | Drug: PropofolAnesthesia is maintained with Propofol |
| Sevoflurane | Experimental | Drug: SevofluraneAnesthesia is maintained with Sevoflurane |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- adenotomy and/or tonsillotomy and/or tonsillectomy
- ASA physical status class I or II
Key exclusion criteria (4 listed)
- unexperienced ear-nose-throat (ENT) surgeon (ENT surgeon < 1 year of training, ENT surgeon without experience with the use of laryngeal mask as airway during adenotomy/tonsillotomy/tonsillectomy)
- preoperative syndromes
- ASA physical status class > 2
- missing written consent from parents/guardians
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 |
|---|---|---|
| PropofolAnesthesia is maintained with a continuous infusion of Propofol. Induction of anesthesia and anesthetic management are otherwise the same in both study arms. | Drug | Propofol |
| SevofluraneAnesthesia is maintained with a continuous inhalation of Sevoflurane. Induction of anesthesia and anesthetic management are otherwise the same in both study arms. | Drug | Sevoflurane |
Primary outcome
Pediatric Anesthesia Emergence Delirium Scale (PAED) ≥ 10
Time frame: 1 hour
A PAED score ≥ 10 during the first hour after emergence from anaesthesia is defined as an ED event occuring
3 secondary outcomes
Face, Legs, Activity, Cry, Consolability Scale (FLACC) ≥ 4
Time frame: 1 hour
Post Hospital Behavioral Questionnaire (PHBQ)
Time frame: 7 days
Post Hospital Behavioral Questionnaire (PHBQ)
Time frame: 30 days
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 1 Mar 2024.
- 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.
Hallvard Græslie, MD study chair
Head of surgical Clinic, Namsos Hospital, Nord-Trondelag Hospital Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol and Sevoflurane in people with Emergence Delirium, run by Helse Nord-Trøndelag HF at 2 sites in Norway.
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 2 inclusion and 4 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 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. 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?
Pediatric Anesthesia Emergence Delirium Scale (PAED) ≥ 10 (time frame: 1 hour). 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 1 Mar 2024.