Trial | NCT04292457  Report issue

Title

Namsos Anaesthesia Children Outcome Study
Namsos Anaesthesia Children Outcome Study (NACOS)

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Recruiting

  • Study Participants

    640
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 Started
Mar 04
2020
Primary Completion
Dec 31
2023
Anticipated
Study Completion
Dec 31
2023
Anticipated
Last Update
Aug 15
2023

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.

Propofol Experimental

Anesthesia is maintained with Propofol

Sevoflurane Experimental

Anesthesia is maintained with Sevoflurane

Criteria 

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
No Results Posted