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

NCT02590744 | Unknown DMC

• 1 other identifier: Xiaoliang-Gan-2015
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Agitation; Child; Anesthesia

Keywords

Emergence Agitation; eye patch; preschool children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• induction compliance checklist

  1 minute before general anesthesia began.

• heart rate (HR)

  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)

  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)

  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

  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.

Study Arms (2)

eye patch

EXPERIMENTAL

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

Behavioral: eye patch

non-eye patch

PLACEBO COMPARATOR

do not cover the sick eye before surgery.

Behavioral: non-eye patch

Interventions

eye patch BEHAVIORAL

cover the sick eye with eye patch preoperatively for 3 hours

Also known as: eye shade, eye shield

eye patch

non-eye patch BEHAVIORAL

do not cover the sick eye with eye patch preoperatively

Also known as: eye shade, eye shield

non-eye patch

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiaoliang Gan: lead

Study Sites (1)

Zhongshan ophthalmic center, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 30032888 DERIVED

MeSH Terms

Conditions

Psychomotor Agitation; Emergence Delirium

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Delirium; Confusion; Postoperative Complications; Pathologic Processes; Neurocognitive Disorders; Mental Disorders

Study Officials

• Yizhi Liu, PhD

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  STUDY CHAIR

Central Study Contacts

Xiaoliang Gan, PhD

CONTACT

+86 13632391455; Ganxl_sysu@126.com

Yiquan Lin, MD

CONTACT

+86 15915896526; liyq889@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: October 22, 2015
• First Posted: October 29, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: June 15, 2017

Record last verified: 2017-06

Locations

CN (1)