Effects of Preoperative Using of Eye Patches on Prevention of Emergence Agitation After Cataract Surgery

Study Overview
=================
Brief 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.

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.

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.

Conditions
-----------------
Agitation, Child, Anesthesia

Intervention / Treatment
-----------------
* Behavioral: eye patch
* Behavioral: non-eye patch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 7 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: eye patch<br>cover the sick eye with eye patch for 3 hours preoperatively. | Behavioral: eye patch<br>* cover the sick eye with eye patch preoperatively for 3 hours<br>* Other names: eye shield;|
| Placebo Comparator: non-eye patch<br>do not cover the sick eye before surgery. | Behavioral: non-eye patch<br>* do not cover the sick eye with eye patch preoperatively<br>* Other names: eye shield;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| induction compliance checklist | measure patients with induction compliance checklist before anesthesia. | 1 minute before general anesthesia began. | 
| heart rate (HR) | measure patients' HR when patient arrived at the post operative care unit | 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 | 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 | 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 | 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Emergence Agitation, eye patch, preschool children