- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04292457
Namsos Anaesthesia Children Outcome Study (NACOS)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kristin Åkerøy, MD
- Phone Number: +47 90642654
- Email: kristin.akeroy@helse-nordtrondelag.no
Study Contact Backup
- Name: Peter H Heidt, MD
- Phone Number: +47 90954880
- Email: peter.heidt@helse-nordtrondelag.no
Study Locations
-
-
Trøndelag
-
Namsos, Trøndelag, Norway, 7800
- Namsos Hospital, Nord-Trondelag Hospital Trust
-
Trondheim, Trøndelag, Norway
- ØNH Legen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- adenotomy and/or tonsillotomy and/or tonsillectomy
- ASA physical status class I or II
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Propofol
Anesthesia is maintained with Propofol
|
Anesthesia is maintained with a continuous infusion of Propofol.
Induction of anesthesia and anesthetic management are otherwise the same in both study arms.
|
Experimental: Sevoflurane
Anesthesia is maintained with Sevoflurane
|
Anesthesia is maintained with a continuous inhalation of Sevoflurane.
Induction of anesthesia and anesthetic management are otherwise the same in both study arms.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Face, Legs, Activity, Cry, Consolability Scale (FLACC) ≥ 4
Time Frame: 1 hour
|
A FLACC score ≥ 4 during the first hour after emergence from anaesthesia is defined as moderate or severe pain
|
1 hour
|
Post Hospital Behavioral Questionnaire (PHBQ)
Time Frame: 7 days
|
An average score > 3 in one or more of the questionnaire categories is defined as postoperative behavioural change
|
7 days
|
Post Hospital Behavioral Questionnaire (PHBQ)
Time Frame: 30 days
|
An average score > 3 in one or more of the questionnaire categories is defined as postoperative behavioural change
|
30 days
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Hallvard Græslie, MD, Head of surgical Clinic, Namsos Hospital, Nord-Trondelag Hospital Trust
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Nervous System Diseases
- Postoperative Complications
- Neurologic Manifestations
- Confusion
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Delirium
- Emergence Delirium
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Platelet Aggregation Inhibitors
- Hypnotics and Sedatives
- Anesthetics, Inhalation
- Propofol
- Sevoflurane
Other Study ID Numbers
- 43654
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Emergence Delirium
-
University of BaghdadCompletedDelirium | Delirium, Anesthesia EmergenceIraq
-
Children's Hospital of Fudan UniversityCompletedDelirium on Emergence
-
Ain Shams UniversityCompletedDelirium on EmergenceEgypt
-
Charite University, Berlin, GermanyCompletedPaediatric Anesthesia Emergence DeliriumGermany
-
Cairo Universityanesthesia department; Faculty of MedicineUnknownEmergence Delirium | Postopertive Delirium | Emergence Agitation in ChildrenEgypt
-
Cairo UniversityRecruiting
-
Baylor College of MedicineCompletedEmergence Delirium | Anesthesia Emergence DeliriumUnited States
-
State University of New York - Upstate Medical...CompletedDelirium on EmergenceUnited States
-
State University of New York at BuffaloTerminatedDelirium on EmergenceUnited States
-
China Medical University, ChinaPeking University People's Hospital; Qilu Hospital of Shandong University; The... and other collaboratorsRecruitingAnalgesia | Delirium on Emergence | SeparationChina
Clinical Trials on Propofol
-
Hopital FochCompleted
-
Konkuk University Medical CenterCompletedCoronary Artery Disease | Valvular Heart DiseaseKorea, Republic of
-
University Medical Center GroningenCompletedAnesthesia | Hemodynamic Instability | Interaction | Disorder of Oxygen TransportNetherlands
-
Asan Medical CenterCompletedPopulation Pharmacokinetics/Pharmacodynamics (PK/PD) of Microemulsion Propofol in Healthy VolunteersHealthyKorea, Republic of
-
Tiva GroupMedtronic - MITGCompleted
-
Pontificia Universidad Catolica de ChileCompletedSurgery | Anesthesia | Depth of Anesthesia | NeonateChile
-
Mansoura UniversityCompleted
-
KVG Medical College and HospitalUnknown
-
Acibadem UniversityCompleted