Anesthetic Depth and the Incidence of Emergence Agitation in Children Undergoing Strabismus Surgery

NCT02521259 | Completed Results

• 1 other identifier: B-1503-289-004
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the association between the depth of general anesthesia and the occurrence of emergence agitation (EA). The investigators hypothesized that optimal level of anesthetic depth could decrease the incidence of EA in children undergoing strabismus surgery compared to the deep level of anesthetic depth.

Conditions

Strabismus

Keywords

anesthetic depth; emergence agitation

Outcome Measures

Primary Outcomes (1)

• the Pediatric Anesthesia Emergence Delirium (PAED) Score

  Evaluating the Pediatric Anesthesia Emergence Delirium (PAED) score 3 times at the post-anesthetic care unit (PACU): when participant arrived at PACU, measure the PAED score (from 0 to 20; the higher score indicates the severer emergenct agitation) immediately and if the score is 10 or over 10, give the participant Fentanyl 1mcg/kg. Repeat checking the PAED score 2 times more with 15 minutes interval.

  30 minutes

Study Arms (2)

low Bispectral index (BIS) group

BIS range under 40

Device: BIS

normal BIS group

BIS range from 40 to 60

Device: BIS

Interventions

BIS DEVICE

BIS monitoring provides the patient's depth of consciousness, enables us to monitor safe, optimal anesthesia for each patient.

low Bispectral index (BIS) group; normal BIS group

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients, aged between 3 and 5 years, scheduled for strabismus surgery

You may qualify if:

• aged between 3 and 5 years
• American Society of Anesthesiologists physical status I or II

You may not qualify if:

• American Society of Anesthesiologists physical status over III,
• any disease that could affect mental status
• pre-existing forehead wound

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital, department of Anesthesia and pain

Seongnam, Gyenggo-do, 13620, South Korea

Location

MeSH Terms

Conditions

Strabismus; Emergence Delirium

Condition Hierarchy (Ancestors)

Ocular Motility Disorders; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. YEA JI LEE
• Organization: Seoul National University Bundang Hospital

ladydaisy82@naver.com

+821086307701

Study Officials

• HYO SEOK NA

  Seoul National University Bundang Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical professor

Study Record Dates

• First Submitted: August 10, 2015
• First Posted: August 13, 2015
• Study Start: April 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: April 1, 2016
• Last Updated: October 21, 2019
• Results First Posted: October 21, 2019

Record last verified: 2019-09

Locations

KR (1)