Changes in Circadian Rhythm After Anaesthesia in Children

Anesthesia Clinical Trial

— CLOCKSkids  

Official title:

The Effect of General Anaesthesia and Surgery on Sleep-wake Timing in Children: the CLOCKS Kids Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05618405
• Other study ID #: W22_068
• Status: Recruiting
• Start date: March 16, 2022
• Est. completion date: March 1, 2024

Study information

• Verified date: November 2022
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Jeroen Hermanides
• Phone: +31-20-5669111
• Email: j.hermanides[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Chronobiology Disorders
• Circadian Rhythm Sleep Disorder
• Disease
• Dyssomnias
• Jet Lag
• Parasomnias
• Sleep
• Sleep Disorders, Circadian Rhythm
• Sleep Disturbance
• Sleep Wake Disorders

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC, locatie AMC	Amsterdam	Noord-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The diurnal phase shift	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.	Baseline (1wk before anesthesia) - First night post-anesthesia
Secondary	Change in sleep quality	The change in subjective sleep quality, including incidence of sleep problems (e.g. sleepwalking, nightmares), as measured by the Children's Sleep Habits Questionnaire (CSHQ), between the month prior to 3 nights pre-anesthesia and 1 week post-anesthesia. This is measured on a likert scale 1 meaning no sleep problems and 5 meaning a lot of sleep problems. The answers from questionnaire 1 (3 days preoperative) are compared to answers of questionnaire 2 (7 days postoperative)	3 days pre-anaesthesia - 7 days post-anaesthesia
Secondary	Changes in all sleep times	Changes in all sleep parameters (i.e. sleep on- and offset times, sleep duration, sleep latency) when comparing baseline (as measured by the Children's ChronoType Questionnaire (CCTQ) 3 days pre-anesthesia) to all 10 nights of the sleeping log.	3 days pre-anaesthesia - 7 days post-anaesthesia
Secondary	Difference in sleep quality between children who had anaesthesia for magnetic resonance imaging and children who had anaesthesia and surgery	Difference in subjective sleep quality (as measured by the CSHQ) between patients receiving anesthesia for magnetic resonance imaging and patients receiving anesthesia for a surgical procedure. Answers are on a likerts scale with 1 meaning no sleep problems and 5 meaning a lot of sleep problems.	3 days pre-anaesthesia - 7 days post-anaesthesia
Secondary	Difference in sleep-wake timing	Difference in changes in sleep-wake timing (as measured by the sleeping log, units are minutes) between patients receiving anesthesia for magnetic resonance imaging and patients receiving anesthesia for a surgical procedure	3 days pre-anaesthesia - 7 days post-anaesthesia