Clinical trial NCT05618405: Changes in Circadian Rhythm After Anaesthesia in Children
Official title: The Effect of General Anaesthesia and Surgery on Sleep-wake Timing in Children: the CLOCKS Kids Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Circadian Rhythm Sleep Disorder
Circadian Rhythm Disorder Caused by Drug
Circadian Rhythm Sleep Disorder, Jet Lag Type
Jet Lag
Anesthesia
Sleep
Sleep Disorders, Circadian Rhythm
Sleep Disturbance
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2022-11-16
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged 1-11 years planned for elective surgery or a procedure requiring general anaesthesia

Brief summary: In this study the investigators will examine the effect of general anesthesia and surgery on sleep duration and sleep quality in children, using questionnaires and a sleep diary.

Detailed description: Objective:

The primary objective is to assess the effect of general anaesthesia and surgery on sleep duration (chronotype) and sleep quality in children aged 1-11 years in the first week after surgery.

Secondary objectives are to determine the duration of the effect of general anaesthesia on chronotype and sleep quality. Furthermore, the investigators will examine factors which may be of influence on the quality and duration of sleep, like postoperative emergence delirium, admission to the hospital, Face, Legs, Activity, Cry, Consolability scale (FLACC) / Numeric Rating Scale (NRS) scores, preoperative sedative medication and postoperative sedative medication.

Study procedures:

Possible participants will be identified on the anaesthetic pre-operative assessment clinic and asked if they object to a phone call with information about research. If not, a researcher will contact the parents by telephone to inform them about the study. After oral consent by both parents, an invitation to fill in the questionnaires will be sent to the parents together with a consent form. Informed consent by both parents will be obtained. Questionnaires can be completed online or on paper, depending on the parents' preference.

Questionnaires:

* Sleep quality: Child's Sleep Habits Questionnaire (CSHQ) on day 3 preoperative and on day 7 postoperative.
* Chronotype: Children's chronotype questionnaire on day 3 preoperative
* Daily sleep diary starting from 3 days preoperative until 7 days postoperative

The following items will be extracted from the electronic health record:

* Demographic criteria: age, gender, type of procedure
* Admission dates
* Preoperative sedative medication
* Postoperative sedative medication
* NRS/FLACC scores during hospital stay All items will be entered in an electronic database (CASTOR)

Primary endpoint The diurnal phase shift the night after surgery, measured by comparing the midpoint of sleep three nights before surgery (as measured by the sleeping log) with midpoint of sleep the night after surgery.

Secondary endpoints

* Change in sleep quality as measured with the CSHQ questionnaire
* Incidence of postoperative sleep problems as measured with the CSHQ questionnaire
* Difference in sleep problems, sleep duration and sleep quality between children who had anaesthesia for magnetic resonance imaging and children who had anaesthesia and surgery
* Influence of pain and sedative medication on sleep duration and quality

Eligibility criteria: Inclusion criteria:

* General anaesthesia for surgery or magnetic resonance imaging (MRI) with a minimal duration of 30 minutes
* Age 1-11 years
* Informed consent of both parents

Exclusion criteria:

* Parents are not fluent in Dutch
* Known severe sleep disturbances
* Postoperative admission to paediatric intensive care unit
* Moderate to severe developmental disorder (IQ\<85)
* American Society of Anesthesiologists (ASA) classification \> 3

Primary outcomes:
measure: The diurnal phase shift
timeFrame: Baseline (1wk before anesthesia) - First night post-anesthesia
Secondary outcomes:
measure: Change in sleep quality
timeFrame: 3 days pre-anaesthesia - 7 days post-anaesthesia
measure: Changes in all sleep times
timeFrame: 3 days pre-anaesthesia - 7 days post-anaesthesia
measure: Difference in sleep quality between children who had anaesthesia for magnetic resonance imaging and children who had anaesthesia and surgery
timeFrame: 3 days pre-anaesthesia - 7 days post-anaesthesia
measure: Difference in sleep-wake timing
timeFrame: 3 days pre-anaesthesia - 7 days post-anaesthesia
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, locatie AMC
state: Noord-Holland
Study officials:
affiliation: Amsterdam UMC
name: Jeroen Hermanides, Prof
role: PRINCIPAL_INVESTIGATOR
References: