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

Sponsor

Xiaoliang Gan (Other)

Overall Status

Unknown status

CT.gov ID

NCT02590744

Collaborator

(none)

180

Enrollment

Location

Arms

Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Agitation Child Anesthesia	Behavioral: eye patch Behavioral: non-eye patch	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

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 Start Date :

Oct 1, 2015

Anticipated Primary Completion Date :

Oct 1, 2017

Anticipated Study Completion Date :

Oct 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: eye patch cover the sick eye with eye patch for 3 hours preoperatively.	Behavioral: eye patch cover the sick eye with eye patch preoperatively for 3 hours Other Names: eye shade eye shield
Placebo Comparator: non-eye patch do not cover the sick eye before surgery.	Behavioral: non-eye patch do not cover the sick eye with eye patch preoperatively Other Names: eye shade eye shield

Arm

Intervention/Treatment

Experimental: eye patch

cover the sick eye with eye patch for 3 hours preoperatively.

Behavioral: eye patch

cover the sick eye with eye patch preoperatively for 3 hours

Other Names:

eye shade

eye shield

Placebo Comparator: non-eye patch

do not cover the sick eye before surgery.

Behavioral: non-eye patch

do not cover the sick eye with eye patch preoperatively

Other Names:

eye shade

eye shield

Outcome Measures

Primary Outcome Measures

the Padiatric Anesthesia Emergence Agitation Scale [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.

Secondary Outcome Measures

induction compliance checklist [1 minute before general anesthesia began.]
measure patients with induction compliance checklist before anesthesia.
heart rate (HR) [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 patients' HR when patient arrived at the post operative care unit
respiration rate(RR) [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' RR and SpO2 when patient arrived at the post operative care unit
oxygen saturation(SpO2) [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' SpO2 when patient arrived at the post operative care unit
incidence rate 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.]
calculate the number of occurrence of emergence agitation

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 7 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.