Namsos Anaesthesia Children Outcome Study

NCT ID: NCT04292457

Last Updated: 2024-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 761 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-04
• Study Completion Date: 2024-01-06

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Propofol

Anesthesia is maintained with Propofol

Group Type: EXPERIMENTAL

Propofol

Intervention Type: DRUG

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

Sevoflurane

Anesthesia is maintained with Sevoflurane

Group Type: EXPERIMENTAL

Sevoflurane

Intervention Type: DRUG

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

Interventions

Propofol

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

Intervention Type: 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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ØNH Legen Trondheim

UNKNOWN

Sponsor Role: collaborator

St. Olavs Hospital

OTHER

Sponsor Role: collaborator

Helse Nord-Trøndelag HF

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hallvard Græslie, MD

Role: STUDY_CHAIR

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

Locations

Namsos Hospital, Nord-Trondelag Hospital Trust

Namsos, Trøndelag, Norway

ØNH Legen

Trondheim, Trøndelag, Norway

Countries

Norway

Other Identifiers

43654

Identifier Type: -

Identifier Source: org_study_id