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

Primary Purpose

Agitation, Child, Anesthesia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
eye patch
non-eye patch
Sponsored by
Xiaoliang Gan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Agitation focused on measuring Emergence Agitation, eye patch, preschool children

Eligibility Criteria

3 Years - 7 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Zhongshan ophthalmic center, Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

eye patch

non-eye patch

Arm Description

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

do not cover the sick eye before surgery.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
October 22, 2015
Last Updated
June 13, 2017
Sponsor
Xiaoliang Gan
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1. Study Identification

Unique Protocol Identification Number
NCT02590744
Brief Title
Effects of Preoperative Using of Eye Patches on Prevention of Emergence Agitation After Cataract Surgery
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 Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
October 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xiaoliang Gan

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Agitation, Child, Anesthesia
Keywords
Emergence Agitation, eye patch, preschool children

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
eye patch
Arm Type
Experimental
Arm Description
cover the sick eye with eye patch for 3 hours preoperatively.
Arm Title
non-eye patch
Arm Type
Placebo Comparator
Arm Description
do not cover the sick eye before surgery.
Intervention Type
Behavioral
Intervention Name(s)
eye patch
Other Intervention Name(s)
eye shade, eye shield
Intervention Description
cover the sick eye with eye patch preoperatively for 3 hours
Intervention Type
Behavioral
Intervention Name(s)
non-eye patch
Other Intervention Name(s)
eye shade, eye shield
Intervention Description
do not cover the sick eye with eye patch preoperatively
Primary Outcome Measure Information:
Title
the Padiatric Anesthesia Emergence Agitation Scale
Description
measure patients with the pediatric anesthesia emergence agitation scale,the score more than 10 is defined as 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.
Secondary Outcome Measure Information:
Title
induction compliance checklist
Description
measure patients with induction compliance checklist before anesthesia.
Time Frame
1 minute before general anesthesia began.
Title
heart rate (HR)
Description
measure patients' HR when patient arrived at the post operative care unit
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.
Title
respiration rate(RR)
Description
measure patients' RR and SpO2 when patient arrived at the post operative care unit
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.
Title
oxygen saturation(SpO2)
Description
measure patients' SpO2 when patient arrived at the post operative care unit
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.
Title
incidence rate of emergence agitation
Description
calculate the number of occurrence 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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoliang Gan, PhD
Phone
+86 13632391455
Email
Ganxl_sysu@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yiquan Lin, MD
Phone
+86 15915896526
Email
liyq889@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yizhi Liu, PhD
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Study Chair
Facility Information:
Facility Name
Zhongshan ophthalmic center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoliang Gan, PhD
Phone
+86 13632391455
Email
Ganxl_sysu@126.com
First Name & Middle Initial & Last Name & Degree
Yiquan Lin, MD
Phone
+86 15915896526
Email
liyq889@163.com
First Name & Middle Initial & Last Name & Degree
Yi Liu, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
30032888
Citation
Lin Y, Shen W, Liu Y, Wang Q, Chen Q, Fang Z, Chi W, Gan X, Liu YZ. Visual preconditioning reduces emergence delirium in children undergoing ophthalmic surgery: a randomised controlled trial. Br J Anaesth. 2018 Aug;121(2):476-482. doi: 10.1016/j.bja.2018.03.033. Epub 2018 May 25.
Results Reference
derived

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

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