Namsos Anaesthesia Children Outcome Study (NACOS)

Helse Nord-Trøndelag HF

Status: Completed

Conditions: Emergence Delirium

Treatments: Drug: Sevoflurane; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT04292457

43654

Details and patient eligibility

About

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.

Enrollment: 761 patients

Sex: All

Ages: 1 to 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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761 participants in 2 patient groups

Propofol

Experimental group

Description:

Anesthesia is maintained with Propofol

Treatment:

Drug: Propofol

Sevoflurane

Experimental group

Description:

Anesthesia is maintained with Sevoflurane

Treatment:

Drug: Sevoflurane