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Completed

NCT Number: NCT05618405

Changes in Circadian Rhythm After Anaesthesia in Children

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The diurnal phase shift

    Time frame: Baseline (1wk before anesthesia) - First night post-anesthesia

    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 outcomes

  1. Change in sleep quality

    Time frame: 3 days pre-anaesthesia - 7 days post-anaesthesia

    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)

  2. Changes in all sleep times

    Time frame: 3 days pre-anaesthesia - 7 days post-anaesthesia

    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. Difference in sleep quality between children who had anaesthesia for magnetic resonance imaging and children who had anaesthesia and surgery

    Time frame: 3 days pre-anaesthesia - 7 days post-anaesthesia

    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.

  4. Difference in sleep-wake timing

    Time frame: 3 days pre-anaesthesia - 7 days post-anaesthesia

    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

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Registry information

Official study title

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

Acronym: CLOCKSkids

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 16, 2022
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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