Postoperative DeliriumNCT03332407
Does Preoperative Sleep Quality Affect the Postoperative Emergence Delirium in Children Undergoing Strabismus Surgery
An observational study of Postoperative Delirium and Strabismus, run by Pusan National University Hospital at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Delirium, Strabismus, Sleep Disorder
- How many people
- 67 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 May 2017to 30 Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Subject of this study is pediatric patients aged 4~12 years, undergoing elective strabismus surgery.
Who may be able to join
- Healthy children without any underlying diseases
- 4~12 years old
- Undergoing strabismus surgery
Who cannot join
- Any underlying diseases
- Disagree
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Postoperative Delirium, Strabismus, Sleep Disorder
- Keywords
- Postoperative delirium, Sleep quality, Pediatric anesthesia, Strabismus surgery
- Medical subject headings
- Emergence Delirium, Strabismus, Sleep Wake Disorders, Sleep Initiation and Maintenance Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative Pittsburgh Sleep Quality Index(PSQI)
- Add the Seven component score. Score range : 0~27
- A total score of "5" or greater is indicative of poor sleep quality.
Measured: 1. Before the surgery ( Within a week before the surgery)
Watcha scale (For emergence delirium)
- 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
Measured: 20 min after awakening ( In the post anesthesia recovery room)
Pediatric anesthesia emergence delirium scale (PAED) scale
- Add the five component score. Score range : 0~20
- A total score of "10" or greater is indicative of emergence delirium.
Measured: 20 min after awakening ( In the post anesthesia recovery room)
Postoperative Pittsburgh Sleep Quality Index(PSQI)
- Add the Seven component score. Score range : 0~27
- A total score of "5" or greater is indicative of poor sleep quality.
Measured: 1 day after the surgery ( < 24 hours )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start2 May 2017
- Primary completion30 Sep 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyeon-Jeong Lee, Pusan National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03332407
- Sponsor's protocol ID
- 2017-1022
- Status last verified
- Nov 2017
- First submitted
- 22 Oct 2017
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Do W, Kim HS, Kim SH, Kang H, Lee D, Baik J, Lee HJ, Hong JM. Sleep quality and emergence delirium in children undergoing strabismus surgery: a comparison between preschool- and school-age patients. BMC Anesthesiol. 2021 Nov 22;21(1):290. doi: 10.1186/s12871-021-01507-2.
PubMed 34809579
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Preoperative Sleep Quality Affect the Postoperative Emergence Delirium in Children Undergoing Strabismus Surgery?
- ClinicalTrials.gov ID
- NCT03332407
- Acronym / sponsor ID
- 2017-1022
- Conditions
- Postoperative Delirium, Strabismus, Sleep Disorder
- Keywords
- Postoperative delirium, Sleep quality, Pediatric anesthesia, Strabismus surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Pusan National University HospitalUniversity, hospital or other
- Study start
- 2 May 2017 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Subject of this study is pediatric patients aged 4~12 years, undergoing elective strabismus surgery.
Key inclusion criteria (3 listed)
- Healthy children without any underlying diseases
- 4~12 years old
- Undergoing strabismus surgery
Key exclusion criteria (2 listed)
- Any underlying diseases
- Disagree
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
- Derived from this study: PubMed 34809579Do W, Kim HS, Kim SH, Kang H, Lee D, Baik J, Lee HJ, Hong JM. Sleep quality and emergence delirium in children undergoing strabismus surgery: a comparison between preschool- and school-age patients. BMC Anesthesiol. 2021 Nov 22;21(1):290. doi: 10.1186/s12871-021-01507-2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Delirium and Strabismus, run by Pusan National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative Pittsburgh Sleep Quality Index(PSQI) (time frame: 1. Before the surgery ( Within a week before the surgery)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03332407, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2017.