AgitationNCT02590744
Effects of Preoperative Using of Eye Patches on Prevention of Emergence Agitation After Cataract Surgery
A study testing eye patch and non-eye patch in people with Agitation and Child, run by Xiaoliang Gan at 1 site in China.
Trial summary
This study is a single-center, prospective, randomized, controlled trial. To investigate if preoperative using of eye patch will decrease emergence agitation, and to provide a better method of decreasing emergence agitation to pediatric ophthalmic anesthesiologists. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Agitation, Child, Anesthesia
- What is being tested?
- eye patch and non-eye patch
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- Oct 2015to Oct 2017
- Phase
- Interventional
- 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 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preschool patients undergo elective cataract surgery, whose age are 3 to 7 years.
- Patients' parents agree to participate in the trial, and sigh the informed consent.
Who cannot join
- Patient who can not communicate with medical workers preoperatively.
- Both of patient's eyes are covered postoperatively.
- Patient's parents refuse to sign informed consent.
- The investigators do not think such patient is suitable for our research
- The patient has serious arrhythmia, abnormal cardiac defect.
- The patient has suffered from pneumonia, asthma symptoms, bronchitis, or upper respiratory tract infection recent two weeks.
- The patient has serious disease of the nervous system.
- The patient has the allergic history of any drug involved in this clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan ophthalmic center, Sun Yat-sen University
Guangzhou, Guangdong, 510080
Xiaoliang Gan, PhD, +86 13632391455, Ganxl_sysu@126.com
Yiquan Lin, MD, +86 15915896526, liyq889@163.com
About this study
Official title: Effects of Preoperative Using of Eye Patches on Prevention of Preschool Children Emergence Agitation After Cataract Surgery: A Single Center, Prospective, Randomized, Controlled Study.
This study is a single-center, prospective, randomized, controlled trial. To investigate if preoperative using of eye patch will decrease emergence agitation, and to provide a better method of decreasing emergence agitation to pediatric ophthalmic anesthesiologists.
Read the detailed description
This study is a single-center, prospective, randomized, controlled trial. To investigate whether preoperative using of eye patches will decrease emergence agitation or not, and to provide a better method of decreasing emergence agitation to pediatric ophthalmic anesthesiologists. The investigators will recruit 180 children undergoing elective cataract surgery, divided into 2 groups by random method. experimental group will cover the effected eye for 3 hours before the operation, while the control group will not. Then the investigators will observe and mesure the incidence of emergence aditation in each group, to assess whether preoperative patch shading can reduce the incidence of postoperative agitation.
- Conditions
- Agitation, Child, Anesthesia
- Being tested
- eye patch, non-eye patch
- Keywords
- Emergence Agitation, eye patch, preschool children
- Medical subject headings
- Psychomotor Agitation, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eye patchBehavioural
Also called eye shade, eye shield
cover the sick eye with eye patch preoperatively for 3 hours
non-eye patchBehavioural
Also called eye shade, eye shield
do not cover the sick eye with eye patch preoperatively
| Study group | Role | What they receive |
|---|---|---|
| eye patch | Experimental | cover the sick eye with eye patch for 3 hours preoperatively. Receives: Behavioral: eye patch |
| non-eye patch | Placebo comparator | do not cover the sick eye before surgery. Receives: Behavioral: non-eye patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Padiatric Anesthesia Emergence Agitation Scale
measure patients with the pediatric anesthesia emergence agitation scale,the score more than 10 is defined as emergence agitation.
Measured: every ten minutes postoperatively, up to 1 hour. Start measuring since the end of surgery until the patient back to ward from postanesthesia care unit.
Secondary outcomes (5)
induction compliance checklist
measure patients with induction compliance checklist before anesthesia.
Measured: 1 minute before general anesthesia began.
heart rate (HR)
measure patients' HR when patient arrived at the post operative care unit
Measured: every ten minutes postoperatively, up to 1 hour. Start measuring since every ten minutes postoperatively, up to 1 hour. Start measuring since the end of surgery until the patient back to ward from postanesthesia care unit.
respiration rate(RR)
measure patients' RR and SpO2 when patient arrived at the post operative care unit
Measured: every ten minutes postoperatively, up to 1 hour. Start measuring since the end of surgery until the patient back to ward from postanesthesia care unit.
oxygen saturation(SpO2)
measure patients' SpO2 when patient arrived at the post operative care unit
Measured: every ten minutes postoperatively, up to 1 hour. Start measuring since the end of surgery until the patient back to ward from postanesthesia care unit.
incidence rate of emergence agitation
calculate the number of occurrence of emergence agitation
Measured: every ten minutes postoperatively, up to 1 hour. Start measuring since the end of surgery until the patient back to ward from postanesthesia care unit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2017 (estimated)
- Study completionOct 2017 (estimated)
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 AgitationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiaoliang Gan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaoliang Gan, Sun Yat-sen University
- Investigators
- Yizhi Liu, PhD, Study chair, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02590744
- Sponsor's protocol ID
- Xiaoliang-Gan-2015
- Status last verified
- Jun 2017
- First submitted
- 22 Oct 2015
- Last updated
- 15 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lin Y, Shen W, Liu Y, Wang Q, Chen Q, Fang Z, Chi W, Gan X, Liu YZ. Visual preconditioning reduces emergence delirium in children undergoing ophthalmic surgery: a randomised controlled trial. Br J Anaesth. 2018 Aug;121(2):476-482. doi: 10.1016/j.bja.2018.03.033. Epub 2018 May 25.
PubMed 30032888
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Preoperative Using of Eye Patches on Prevention of Preschool Children Emergence Agitation After Cataract Surgery: A Single Center, Prospective, Randomized, Controlled Study.
- ClinicalTrials.gov ID
- NCT02590744
- Acronym / sponsor ID
- Xiaoliang-Gan-2015
- Conditions
- Agitation, Child, Anesthesia
- Keywords
- Emergence Agitation, eye patch, preschool children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Xiaoliang GanUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 29 Oct 2015 (estimated)
- 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.
This study is a single-center, prospective, randomized, controlled trial. To investigate if preoperative using of eye patch will decrease emergence agitation, and to provide a better method of decreasing emergence agitation to pediatric ophthalmic anesthesiologists.
Detailed description
This study is a single-center, prospective, randomized, controlled trial. To investigate whether preoperative using of eye patches will decrease emergence agitation or not, and to provide a better method of decreasing emergence agitation to pediatric ophthalmic anesthesiologists. The investigators will recruit 180 children undergoing elective cataract surgery, divided into 2 groups by random method. experimental group will cover the effected eye for 3 hours before the operation, while the control group will not. Then the investigators will observe and mesure the incidence of emergence aditation in each group, to assess whether preoperative patch shading can reduce the incidence of postoperative agitation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eye patch | Experimental | Behavioral: eye patchcover the sick eye with eye patch for 3 hours preoperatively. |
| non-eye patch | Placebo comparator | Behavioral: non-eye patchdo not cover the sick eye before surgery. |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Preschool patients undergo elective cataract surgery, whose age are 3 to 7 years.
- Patients' parents agree to participate in the trial, and sigh the informed consent.
Key exclusion criteria (8 listed)
- Patient who can not communicate with medical workers preoperatively.
- Both of patient's eyes are covered postoperatively.
- Patient's parents refuse to sign informed consent.
- The investigators do not think such patient is suitable for our research
- The patient has serious arrhythmia, abnormal cardiac defect.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eye patchAlso: eye shade, eye shieldcover the sick eye with eye patch preoperatively for 3 hours | Behavioural | eye patch |
| non-eye patchAlso: eye shade, eye shielddo not cover the sick eye with eye patch preoperatively | Behavioural | non-eye patch |
Primary outcome
the Padiatric Anesthesia Emergence Agitation Scale
Time frame: every ten minutes postoperatively, up to 1 hour. Start measuring since the end of surgery until the patient back to ward from postanesthesia care unit.
measure patients with the pediatric anesthesia emergence agitation scale,the score more than 10 is defined as emergence agitation.
5 secondary outcomes
induction compliance checklist
Time frame: 1 minute before general anesthesia began.
heart rate (HR)
Time frame: every ten minutes postoperatively, up to 1 hour. Start measuring since every ten minutes postoperatively, up to 1 hour. Start measuring since the end of surgery until the patient back to ward from postanesthesia care unit.
respiration rate(RR)
Time frame: every ten minutes postoperatively, up to 1 hour. Start measuring since the end of surgery until the patient back to ward from postanesthesia care unit.
oxygen saturation(SpO2)
Time frame: every ten minutes postoperatively, up to 1 hour. Start measuring since the end of surgery until the patient back to ward from postanesthesia care unit.
incidence rate of emergence agitation
Time frame: every ten minutes postoperatively, up to 1 hour. Start measuring since the end of surgery until the patient back to ward from postanesthesia care unit.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2017.
- Derived from this study: PubMed 30032888Lin Y, Shen W, Liu Y, Wang Q, Chen Q, Fang Z, Chi W, Gan X, Liu YZ. Visual preconditioning reduces emergence delirium in children undergoing ophthalmic surgery: a randomised controlled trial. Br J Anaesth. 2018 Aug;121(2):476-482. doi: 10.1016/j.bja.2018.03.033. Epub 2018 May 25.
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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.
Yizhi Liu, PhD study chair
Zhongshan Ophthalmic Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eye patch and non-eye patch in people with Agitation and Child, run by Xiaoliang Gan at 1 site in China.
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 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 15 Jun 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 China. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoliang Gan, PhD (+86 13632391455, Ganxl_sysu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Padiatric Anesthesia Emergence Agitation Scale (time frame: every ten minutes postoperatively, up to 1 hour. Start measuring since the end of surgery until the patient back to ward from postanesthesia care unit.). 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 NCT02590744, 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 15 Jun 2017.