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

June 13, 2017 updated by: Xiaoliang Gan

Effects of Preoperative Using of Eye Patches on Prevention of Preschool Children Emergence Agitation After Cataract Surgery: A Single Center, Prospective, Randomized, Controlled Study.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • Zhongshan Ophthalmic Center, Sun Yat-sen University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yi Liu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the Padiatric Anesthesia Emergence Agitation Scale
Time Frame: 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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
induction compliance checklist
Time Frame: 1 minute before general anesthesia began.
measure patients with induction compliance checklist before anesthesia.
1 minute before general anesthesia began.
heart rate (HR)
Time Frame: 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
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.
respiration rate(RR)
Time Frame: 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
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.
oxygen saturation(SpO2)
Time Frame: 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
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.
incidence rate of emergence agitation
Time Frame: 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
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiaoliang Gan

Investigators

  • Study Chair: Yizhi Liu, PhD, Zhongshan Ophthalmic Center, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

October 22, 2015

First Submitted That Met QC Criteria

October 28, 2015

First Posted (Estimate)

October 29, 2015

Study Record Updates

Last Update Posted (Actual)

June 15, 2017

Last Update Submitted That Met QC Criteria

June 13, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Xiaoliang-Gan-2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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