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

Anesthesia Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02590744
• Other study ID #: Xiaoliang-Gan-2015
• Status: Recruiting
• Phase: N/A
• First received: October 22, 2015
• Last updated: June 13, 2017
• Start date: October 2015
• Est. completion date: October 2017

Study information

• Verified date: June 2017
• Source: Sun Yat-sen University
• Contact: Xiaoliang Gan, PhD
• Phone: +86 13632391455
• Email: Ganxl_sysu[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 7 Years

Eligibility

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.

Related Conditions & MeSH terms

• Agitation
• Anesthesia
• Capsule Opacification
• Cataract
• Child
• Psychomotor Agitation

Intervention

Behavioral:
• eye patch
cover the sick eye with eye patch preoperatively for 3 hours
• non-eye patch
do not cover the sick eye with eye patch preoperatively

Locations

Country	Name	City	State
China	Zhongshan ophthalmic center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Xiaoliang Gan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	induction compliance checklist	measure patients with induction compliance checklist before anesthesia.	1 minute before general anesthesia began.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.