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Namsos Anaesthesia Children Outcome Study (NACOS)

Primary Purpose

Emergence Delirium

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Propofol
Sevoflurane
Sponsored by
Helse Nord-Trøndelag HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Emergence Delirium focused on measuring Pediatric Anaesthesia, Emergence Delirium, Postoperative Behavioral Changes, Sevoflurane, Propofol, Adenotonsillectomy

Eligibility Criteria

1 Year - 10 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Namsos Hospital, Nord-Trondelag Hospital TrustRecruiting
  • ØNH LegenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Propofol

Sevoflurane

Arm Description

Anesthesia is maintained with Propofol

Anesthesia is maintained with Sevoflurane

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Post Hospital Behavioral Questionnaire (PHBQ)
An average score > 3 in one or more of the questionnaire categories is defined as postoperative behavioural change
Post Hospital Behavioral Questionnaire (PHBQ)
An average score > 3 in one or more of the questionnaire categories is defined as postoperative behavioural change

Full Information

First Posted
February 29, 2020
Last Updated
August 14, 2023
Sponsor
Helse Nord-Trøndelag HF
Collaborators
ØNH Legen Trondheim, St. Olavs Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04292457
Brief Title
Namsos Anaesthesia Children Outcome Study
Acronym
NACOS
Official Title
Namsos Anaesthesia Children Outcome Study (NACOS)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 4, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helse Nord-Trøndelag HF
Collaborators
ØNH Legen Trondheim, St. Olavs Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergence Delirium
Keywords
Pediatric Anaesthesia, Emergence Delirium, Postoperative Behavioral Changes, Sevoflurane, Propofol, Adenotonsillectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
640 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Propofol
Arm Type
Experimental
Arm Description
Anesthesia is maintained with Propofol
Arm Title
Sevoflurane
Arm Type
Experimental
Arm Description
Anesthesia is maintained with Sevoflurane
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
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
Intervention Name(s)
Sevoflurane
Intervention Description
Anesthesia is maintained with a continuous inhalation of Sevoflurane. Induction of anesthesia and anesthetic management are otherwise the same in both study arms.
Primary Outcome Measure Information:
Title
Pediatric Anesthesia Emergence Delirium Scale (PAED) ≥ 10
Description
A PAED score ≥ 10 during the first hour after emergence from anaesthesia is defined as an ED event occuring
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Face, Legs, Activity, Cry, Consolability Scale (FLACC) ≥ 4
Description
A FLACC score ≥ 4 during the first hour after emergence from anaesthesia is defined as moderate or severe pain
Time Frame
1 hour
Title
Post Hospital Behavioral Questionnaire (PHBQ)
Description
An average score > 3 in one or more of the questionnaire categories is defined as postoperative behavioural change
Time Frame
7 days
Title
Post Hospital Behavioral Questionnaire (PHBQ)
Description
An average score > 3 in one or more of the questionnaire categories is defined as postoperative behavioural change
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristin Åkerøy, MD
Phone
+47 90642654
Email
kristin.akeroy@helse-nordtrondelag.no
First Name & Middle Initial & Last Name or Official Title & Degree
Peter H Heidt, MD
Phone
+47 90954880
Email
peter.heidt@helse-nordtrondelag.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hallvard Græslie, MD
Organizational Affiliation
Head of surgical Clinic, Namsos Hospital, Nord-Trondelag Hospital Trust
Official's Role
Study Chair
Facility Information:
Facility Name
Namsos Hospital, Nord-Trondelag Hospital Trust
City
Namsos
State/Province
Trøndelag
ZIP/Postal Code
7800
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter H Heidt, MD
Phone
+47 90954880
Email
peter.heidt@helse-nordtrondelag.no
First Name & Middle Initial & Last Name & Degree
Kristin Åkerøy, MD
Phone
+4790642654
Email
kristin.akeroy@helse-nordtrondelag.no
Facility Name
ØNH Legen
City
Trondheim
State/Province
Trøndelag
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Heidt, MD
Phone
+47 90954880
Email
peter.heidt@helse-nordtrondelag.no

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Namsos Anaesthesia Children Outcome Study

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