Clinical trial NCT02590744: Effects of Preoperative Using of Eye Patches on Prevention of Emergence Agitation After Cataract Surgery
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Agitation
Child
Anesthesia
Keywords: Emergence Agitation
eye patch
preschool children
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2015-10-29
Enrollment: 180
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

1. Preschool patients undergo elective cataract surgery, whose age are 3 to 7 years.
2. Patients' parents agree to participate in the trial, and sigh the informed consent.

Exclusion Criteria:

1. Patient who can not communicate with medical workers preoperatively.
2. Both of patient's eyes are covered postoperatively.
3. Patient's parents refuse to sign informed consent.
4. The investigators do not think such patient is suitable for our research
5. The patient has serious arrhythmia, abnormal cardiac defect.
6. The patient has suffered from pneumonia, asthma symptoms, bronchitis, or upper respiratory tract infection recent two weeks.
7. The patient has serious disease of the nervous system.
8. The patient has the allergic history of any drug involved in this clinical trial.

Primary outcomes:
measure: the Padiatric Anesthesia Emergence Agitation Scale
timeFrame: 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:
measure: induction compliance checklist
timeFrame: 1 minute before general anesthesia began.
measure: heart rate (HR)
timeFrame: 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.
measure: respiration rate(RR)
timeFrame: 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: oxygen saturation(SpO2)
timeFrame: 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: incidence rate of emergence agitation
timeFrame: 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.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan ophthalmic center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Yizhi Liu, PhD
role: STUDY_CHAIR
References:
citation: 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.