NCT04292457

Namsos Anaesthesia Children Outcome Study

Namsos Anaesthesia Children Outcome Study (NACOS)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 761 (actual)
• Sponsor: Helse Nord-Trøndelag HF · Academic / Other
• Sex: All
• Age: 1 Year – 10 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Emergence Delirium

Interventions

Type	Name	Description
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.
DRUG	Sevoflurane	Anesthesia is maintained with a continuous inhalation of Sevoflurane. Induction of anesthesia and anesthetic management are otherwise the same in both study arms.

Timeline

• Start date: 2020-03-04
• Primary completion: 2023-12-06
• Completion: 2024-01-06
• First posted: 2020-03-03
• Last updated: 2024-03-01

Locations

2 sites across 1 country: Norway