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: Completed
• Conditions: Emergence Delirium
• Intervention / Treatment: Drug: Propofol; Drug: Sevoflurane

• Study Type: Interventional
• Enrollment (Actual): 761
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Trøndelag
    • Namsos, Trøndelag, Norway, 7800
      • Namsos Hospital, Nord-Trondelag Hospital Trust
    • Trondheim, Trøndelag, Norway
      • ØNH Legen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 10 years (Child)
• Accepts Healthy Volunteers: No

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Propofol; Anesthesia is maintained with Propofol	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.
Experimental: Sevoflurane; Anesthesia is maintained with Sevoflurane	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Helse Nord-Trøndelag HF
• Collaborators: St. Olavs Hospital; ØNH Legen Trondheim
• 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): March 4, 2020
• Primary Completion (Actual): December 6, 2023
• Study Completion (Actual): January 6, 2024

Study Registration Dates

• First Submitted: February 29, 2020
• First Submitted That Met QC Criteria: February 29, 2020
• First Posted (Actual): March 3, 2020

Study Record Updates

• Last Update Posted (Estimated): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Propofol; Sevoflurane; Adenotonsillectomy; Emergence Delirium; Pediatric Anaesthesia; Postoperative Behavioral Changes
• 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)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No