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NCT Number: NCT03332407

Does Preoperative Sleep Quality Affect the Postoperative Emergence Delirium in Children Undergoing Strabismus Surgery

Sleep is important in maintaining the physiological function of the human body. Recently several studies have reported that preoperative sleep quality is associated with postoperative emergence delirium (ED) The ED is a common in pediatric patients undergoing general anesthesia with sevoflurane, but studies on the association of sleep quality have been rare. The investigators, therefore, aimed to investigate the relationship between postoperative delirium and pre and postoperative sleep quality in pediatric patients receiving strabismus surgery through this study

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Key information

Conditions

Postoperative Delirium Confusion Cranial Nerve Diseases Delirium Dyssomnias Emergence Delirium Eye Diseases Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Ocular Motility Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Sleep Disorder Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Strabismus

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pusan national university hospital

Busan, South Korea

About this study

This study aimed on pediatric patients aged 4-12 years, undergoing elective strabismus surgery. Informed consent was obtained from both parents and children on the day of pre-anesthetic evaluation visit. The child and his or her parents were questioned on preoperative patient's sleep quality based on Pittsburg Sleep Quality Index (PSQI). Surgery was performed under the same anesthesia as usual. After the operation, extubation was performed and patient was moved to post anesthesia recovery room (PACU). During the stay in PACU, one investigator measured degree of ED by Watcha and PAED (Post anesthesia emergence delirium ) scale to minimize bias. One day after the surgery, the investigator mede a phone call to the parents of the patient to obtain information for postoperative PSQI.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy children without any underlying diseases
  • 4~12 years old
  • Undergoing strabismus surgery

Exclusion criteria

  • Any underlying diseases
  • Disagree

Treatment and study plan

Primary outcomes

  1. Preoperative Pittsburgh Sleep Quality Index(PSQI)

    Time frame: 1. Before the surgery ( Within a week before the surgery)

    • Add the Seven component score. Score range : 0~27
    • A total score of "5" or greater is indicative of poor sleep quality.

  2. Watcha scale (For emergence delirium)

    Time frame: 20 min after awakening ( In the post anesthesia recovery room)

    • Measure the score of most appropriate state of condition. There are four conditions. Score range : 1~4
    • The score of "3" or greater is indicative of emergence delirium

  3. Pediatric anesthesia emergence delirium scale (PAED) scale

    Time frame: 20 min after awakening ( In the post anesthesia recovery room)

    • Add the five component score. Score range : 0~20
    • A total score of "10" or greater is indicative of emergence delirium.

  4. Postoperative Pittsburgh Sleep Quality Index(PSQI)

    Time frame: 1 day after the surgery ( < 24 hours )

    • Add the Seven component score. Score range : 0~27
    • A total score of "5" or greater is indicative of poor sleep quality.

Sponsors and collaborators

Lead sponsor

Pusan National University Hospital

Other

Registry information

Official study title

Does Preoperative Sleep Quality Affect the Postoperative Emergence Delirium in Children Undergoing Strabismus Surgery?

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Nov 6, 2017
Registry last updated
Nov 7, 2017

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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