Changes in Circadian Rhythm After Anaesthesia in Children

NCT05618405 | Completed

• 1 other identifier: W22_068
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in sleep quality

  3 days pre-anaesthesia - 7 days post-anaesthesia

• Changes in all sleep times

  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

  3 days pre-anaesthesia - 7 days post-anaesthesia

• Difference in sleep-wake timing

  3 days pre-anaesthesia - 7 days post-anaesthesia

Study Arms (2)

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.

Eligibility Criteria

• Age: 1 Year - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Amsterdam UMC, locatie AMC

Amsterdam, North Holland, 1105AZ, Netherlands

Location

MeSH Terms

Conditions

Sleep Disorders, Circadian Rhythm; Jet Lag Syndrome; Parasomnias

Condition Hierarchy (Ancestors)

Chronobiology Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Occupational Diseases; Mental Disorders; Travel-Related Illness; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeroen Hermanides, Prof

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Anesthesiologist, principal investigator

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: November 16, 2022
• Study Start: March 16, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: July 31, 2024

Record last verified: 2024-07

Locations

NL (1)