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

Not Applicable

• Conditions: Child; Agitation; Anesthesia
• Interventions: Behavioral: eye patch; Behavioral: non-eye patch

• Registration Number: NCT02590744
• Lead Sponsor: Xiaoliang Gan

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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-22
• Study First Submitted QC: 2015-10-28
• Study First Posted: 2015-10-29
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-13
• Last Update Posted: 2017-06-15
• Primary Completion: 2017-10
• Study Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
eye patch	eye patch	cover the sick eye with eye patch for 3 hours preoperatively.
non-eye patch	non-eye patch	do not cover the sick eye before surgery.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Zhongshan ophthalmic center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China