Namsos Anaesthesia Children Outcome Study

NCT04292457 | Completed

• 1 other identifier: 43654
• Study Type: interventional
• Target: 761
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Pediatric Anaesthesia; Emergence Delirium; Postoperative Behavioral Changes; Sevoflurane; Propofol; Adenotonsillectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Face, Legs, Activity, Cry, Consolability Scale (FLACC) ≥ 4

  1 hour

• Post Hospital Behavioral Questionnaire (PHBQ)

  7 days

• Post Hospital Behavioral Questionnaire (PHBQ)

  30 days

Study Arms (2)

Propofol

EXPERIMENTAL

Anesthesia is maintained with Propofol

Drug: Propofol

Sevoflurane

EXPERIMENTAL

Anesthesia is maintained with Sevoflurane

Drug: Sevoflurane

Interventions

Propofol DRUG

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

Propofol

Sevoflurane DRUG

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

Sevoflurane

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• adenotomy and/or tonsillotomy and/or tonsillectomy
• ASA physical status class I or II

You may not qualify if:

• 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

Sponsors & Collaborators

• Helse Nord-Trøndelag HF: lead
• ØNH Legen Trondheim: collaborator
• St. Olavs Hospital: collaborator

Study Sites (2)

Namsos Hospital, Nord-Trondelag Hospital Trust

Namsos, Trøndelag, 7800, Norway

Location

ØNH Legen

Trondheim, Trøndelag, Norway

Location

MeSH Terms

Conditions

Emergence Delirium

Interventions

Propofol; Sevoflurane

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Officials

• Hallvard Græslie, MD

  Head of surgical Clinic, Namsos Hospital, Nord-Trondelag Hospital Trust

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2020
• First Posted: March 3, 2020
• Study Start: March 4, 2020
• Primary Completion: December 6, 2023
• Study Completion: January 6, 2024
• Last Updated: March 1, 2024

Record last verified: 2024-02

Locations

NO (2)