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

Sponsor
Pusan National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03332407
Collaborator
(none)
67
Enrollment
1
Location
5
Actual Duration (Months)
13.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    67 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Does Preoperative Sleep Quality Affect the Postoperative Emergence Delirium in Children Undergoing Strabismus Surgery?
    Actual Study Start Date :
    May 2, 2017
    Actual Primary Completion Date :
    Sep 30, 2017
    Actual Study Completion Date :
    Sep 30, 2017

    Outcome Measures

    Primary Outcome Measures

    1. Preoperative Pittsburgh Sleep Quality Index(PSQI) [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) [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 [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) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Healthy children without any underlying diseases

    • 4~12 years old

    • Undergoing strabismus surgery

    Exclusion Criteria:

    • Any underlying diseases

    • Disagree

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pusan national university hospital Busan Korea, Republic of

    Sponsors and Collaborators

    • Pusan National University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hyeon-Jeong Lee, Associated professor, Pusan National University Hospital
    ClinicalTrials.gov Identifier:
    NCT03332407
    Other Study ID Numbers:
    • 2017-1022
    First Posted:
    Nov 6, 2017
    Last Update Posted:
    Nov 7, 2017
    Last Verified:
    Nov 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hyeon-Jeong Lee, Associated professor, Pusan National University Hospital
    Postoperative delirium
    Sleep quality
    Pediatric anesthesia
    Strabismus surgery
    Additional relevant MeSH terms:
    Delirium
    Sleep Wake Disorders
    Strabismus
    Emergence Delirium

    Study Results

    No Results Posted as of Nov 7, 2017