Changes in Circadian Rhythm After Anaesthesia in Children (CLOCKSkids)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Sleep; Sleep Disturbance; Anesthesia; Sleep Disorders, Circadian Rhythm; Circadian Rhythm Sleep Disorder; Circadian Rhythm Disorder Caused by Drug; Circadian Rhythm Sleep Disorder, Jet Lag Type; Jet Lag

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

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Jeroen Hermanides; Phone Number: +31-20-5669111; Email: j.hermanides@amsterdamumc.nl
• Study Contact Backup: Name: Jorinde Polderman; Phone Number: +31-20-5669111; Email: j.a.polderman@amsterdamumc.nl

Study Locations

• Netherlands
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1105AZ
      • Recruiting
      • Amsterdam UMC, locatie AMC
      • Contact: Jeroen Hermanides; Phone Number: +31-20-5669111; Email: j.hermanides@amsterdamumc.nl
      • Contact: Jorinde Polderman; Phone Number: +31-20-5669111; Email: j.a.polderman@amsterdamumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children aged 1-11 years planned for elective surgery or a procedure requiring general anaesthesia

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Children who undergo anesthesia because of surgery; Children, aged between 1-11 years, who undergo general anesthesia because of surgery.
Children who undergo anesthesia because of an MRI; Children, aged between 1-11 years, who undergo general anesthesia because of an MRI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2022
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: April 13, 2022
• First Submitted That Met QC Criteria: November 11, 2022
• First Posted (Actual): November 16, 2022

Study Record Updates

• Last Update Posted (Actual): November 16, 2022
• Last Update Submitted That Met QC Criteria: November 11, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Occupational Diseases; Travel-Related Illness; Disease; Sleep Wake Disorders; Dyssomnias; Parasomnias; Sleep Disorders, Circadian Rhythm; Chronobiology Disorders; Jet Lag Syndrome
• Other Study ID Numbers: W22_068

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No