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

November 5, 2017 updated by: Hyeon-Jeong Lee, Pusan National University Hospital

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

67

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subject of this study is pediatric patients aged 4~12 years, undergoing elective strabismus surgery.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Any underlying diseases
  • Disagree

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preoperative Pittsburgh Sleep Quality Index(PSQI)
Time Frame: 1. Before the surgery ( Within a week before the surgery)
  1. Add the Seven component score. Score range : 0~27
  2. A total score of "5" or greater is indicative of poor sleep quality.
1. Before the surgery ( Within a week before the surgery)
Watcha scale (For emergence delirium)
Time Frame: 20 min after awakening ( In the post anesthesia recovery room)
  1. Measure the score of most appropriate state of condition. There are four conditions. Score range : 1~4
  2. The score of "3" or greater is indicative of emergence delirium
20 min after awakening ( In the post anesthesia recovery room)
Pediatric anesthesia emergence delirium scale (PAED) scale
Time Frame: 20 min after awakening ( In the post anesthesia recovery room)
  1. Add the five component score. Score range : 0~20
  2. A total score of "10" or greater is indicative of emergence delirium.
20 min after awakening ( In the post anesthesia recovery room)
Postoperative Pittsburgh Sleep Quality Index(PSQI)
Time Frame: 1 day after the surgery ( < 24 hours )
  1. Add the Seven component score. Score range : 0~27
  2. A total score of "5" or greater is indicative of poor sleep quality.
1 day after the surgery ( < 24 hours )

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pusan National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2017

Primary Completion (Actual)

September 30, 2017

Study Completion (Actual)

September 30, 2017

Study Registration Dates

First Submitted

October 22, 2017

First Submitted That Met QC Criteria

November 1, 2017

First Posted (Actual)

November 6, 2017

Study Record Updates

Last Update Posted (Actual)

November 7, 2017

Last Update Submitted That Met QC Criteria

November 5, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-1022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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