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

NCT ID: NCT02521259

Last Updated: 2019-10-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 68 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2016-04-30

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.

Detailed Description

EA is characterized by dissociated state of consciousness, in which the children are inconsolable, irritable, uncooperative, thrashing, crying, moaning or incoherent.

Several predisposing factors for EA include post-operative pain, rapid emergence from general anesthesia, use of volatile anesthetics, type and site of operation (usually head & neck surgeries), agitation on induction, airway obstruction, hyperthermia or hypothermia.

The effect of anesthetic depth on the EA has rarely been evaluated in pediatric population, even though postoperative delirium or postoperative cognitive dysfunction (POCD)corresponds to the EA identically.

In this study, the concentration of anesthetics was not managed on purpose to lower the BIS score. Patients were allocated to each group based on the result of average BIS score during the operation.

Conditions

Strabismus

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

low Bispectral index (BIS) group

BIS range under 40

BIS

Intervention Type: DEVICE

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

normal BIS group

BIS range from 40 to 60

BIS

Intervention Type: DEVICE

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

Interventions

BIS

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Bundang Hospital

OTHER

Sponsor Role: lead

Responsible Party

LEE YEA JI

clinical professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

HYO SEOK NA

Role: STUDY_DIRECTOR

Seoul National University Bundang Hospital

Locations

Seoul National University Bundang Hospital, department of Anesthesia and pain

Seongnam, Gyenggo-do, South Korea

Countries

South Korea

Other Identifiers

B-1503-289-004

Identifier Type: -

Identifier Source: org_study_id