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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04292457
Other study ID # 43654
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 4, 2020
Est. completion date January 6, 2024

Study information

Verified date February 2024
Source Helse Nord-Trøndelag HF
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 761
Est. completion date January 6, 2024
Est. primary completion date December 6, 2023
Accepts healthy volunteers No
Gender All
Age group 1 Year to 10 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Norway Namsos Hospital, Nord-Trondelag Hospital Trust Namsos Trøndelag
Norway ØNH Legen Trondheim Trøndelag

Sponsors (3)

Lead Sponsor Collaborator
Helse Nord-Trøndelag HF ØNH Legen Trondheim, St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
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