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Namsos Anaesthesia Children Outcome Study

NCT04292457 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 761

Last updated 2024-03-01

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • ØNH Legen Trondheim

    collaborator UNKNOWN

  • St. Olavs Hospital

    collaborator OTHER

  • Helse Nord-Trøndelag HF

    lead OTHER

Principal Investigators

  • Hallvard Græslie, MD · Head of surgical Clinic, Namsos Hospital, Nord-Trondelag Hospital Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-04
Primary Completion
2023-12-06
Completion
2024-01-06

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04292457 on ClinicalTrials.gov