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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02590744
Other study ID # Xiaoliang-Gan-2015
Secondary ID
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
Health authority
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.

Study Design


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.
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