Namsos Anaesthesia Children Outcome Study

Emergence Delirium Clinical Trial

— NACOS  

Official title:

Namsos Anaesthesia Children Outcome Study (NACOS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04292457
• Other study ID #: 43654
• Status: Completed
• Phase: N/A
• Start date: March 4, 2020
• Est. completion date: January 6, 2024

Study information

• Verified date: February 2024
• Source: Helse Nord-Trøndelag HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 761
• Est. completion date: January 6, 2024
• Est. primary completion date: December 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Emergence Delirium

Intervention

Drug:
• Propofol
Anesthesia is maintained with a continuous infusion of Propofol. Induction of anesthesia and anesthetic management are otherwise the same in both study arms.
• Sevoflurane
Anesthesia is maintained with a continuous inhalation of Sevoflurane. Induction of anesthesia and anesthetic management are otherwise the same in both study arms.

Locations

Country	Name	City	State
Norway	Namsos Hospital, Nord-Trondelag Hospital Trust	Namsos	Trøndelag
Norway	ØNH Legen	Trondheim	Trøndelag

Sponsors (3)

Lead Sponsor	Collaborator
Helse Nord-Trøndelag HF	ØNH Legen Trondheim, St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 hour
Secondary	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	1 hour
Secondary	Post Hospital Behavioral Questionnaire (PHBQ)	An average score > 3 in one or more of the questionnaire categories is defined as postoperative behavioural change	7 days
Secondary	Post Hospital Behavioral Questionnaire (PHBQ)	An average score > 3 in one or more of the questionnaire categories is defined as postoperative behavioural change	30 days