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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Agitation Child Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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eye patch

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

Group Type EXPERIMENTAL

eye patch

Intervention Type BEHAVIORAL

cover the sick eye with eye patch preoperatively for 3 hours

non-eye patch

do not cover the sick eye before surgery.

Group Type PLACEBO_COMPARATOR

non-eye patch

Intervention Type BEHAVIORAL

do not cover the sick eye with eye patch preoperatively

Interventions

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eye patch

cover the sick eye with eye patch preoperatively for 3 hours

Intervention Type BEHAVIORAL

non-eye patch

do not cover the sick eye with eye patch preoperatively

Intervention Type BEHAVIORAL

Other Intervention Names

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eye shade eye shield eye shade eye shield

Eligibility Criteria

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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.

Minimum Eligible Age

3 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No