Performance of EEG During Emergence Agitation in Nasal Surgery.

The Relationship Between Emergence Agitation and Electroencephalogram in Young Adults Undergoing Nasal Surgery Under General Anesthesia

The purpose of the study is to evaluate the relationship between perioperative electroencephalogram and emergence agitation in the nasal surgery. Previous studies showed that low frequency band wave activity increased during emergence delirium in pediatric patients. It is still not enough to explain the relationship between emergence agitation and electroencephalogram in adults. Researchers will demonstrate the relationship between parameters related electroencephalogram and emergence agitation in adults undergoing nasal surgery.

Study Overview

• Status: Recruiting
• Conditions: Nasal Surgery
• Intervention / Treatment: Other: Nasal surgery

Detailed Description

Researchers use Sedline to perform perioperative EEG measurements of young adult patients undergoing nasal surgery under general anesthesia with sevoflurane. Emergence agitation occurrence and EEG patterns are observed.

The researchers record the patient's sex, type of surgery, pre-education on emergence agitation, preoperative hospital anxiety and depression scale (HADS), postoperative pain, amount of analgesics administered in the surgery/recovery room, and PACU time. Investigators check the correlation between EEG and perioperative variables. Investigators also compare EEG and perioperative variables for those who were given an explanation of emergence agitation and those who were not.

• Study Type: Observational
• Enrollment (Estimated): 55

Contacts and Locations

• Study Contact: Name: Young Song; Phone Number: 82-2-2019-6692; Email: NEARMYHEART@yuhs.ac
• Study Contact Backup: Name: Jiwon Lee; Phone Number: 82-2-2019-6807; Email: BELIEF705@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Gangnam Severance Hospital Yonsei University College of Medicine
    • Contact: Young Song; Phone Number: 82-2-2019-4601; Email: NEARMYHEART@yuhs.ac
    • Contact: Jiwon Lee; Phone Number: 82-2-2019-4601; Email: BELIEF705@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 51 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study collects subjects from a tertiary university hospital.

Description

Inclusion Criteria:

• Adult patients aged 19-55 years who are undergoing nasal surgery under general anesthesia using inhalational agent

Exclusion Criteria:

• CNS disease (ex.dementia, stroke, brain tumor, psychological disorder..)
• unable to communicate
• general anesthesia history within 6 months
• disagree to participate in study

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EEG band relative power measured in the frontal lobe	relative power of each brain waves : Original frontal EEG waves using 4 channel sedline (Masimo, Irvine, CA, USA) sensor will processed by FFT(fast Fourier transform). Each band is as follows.: Delta: 1-4 Hz Theta: 4-8 Hz Alpha: 8-13 Hz Beta: 13-30 Hz.	From the cessation of sevoflurane inhalation to the extubation of tracheal tubes
occurrence of emergence agitation	Emergence agitation occurrence : RASS(Richmond Agitation Sedation Score) is 10 scaled (-5~+4) score to assess sedation/agitation level; 0 is a calm state, and a value less than 0 means a sedation state.	From the cessation of sevoflurane inhalation to transfer to the recovery room

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HADS (Hospital Anxiety and Depression Scale)	A self-assessment scale, brief, clinically useful measure of anxiety and depression symptoms. It can be used to diagnose depression in people with significant physical ill-health.	1 day before surgery (after admission)
VAS (Visual Analogue Scale)	Using a ruler, it is 11 scaled (0-10) score to assess pain.	during 30 minutes after PACU admission
Effect of preoperative education on emergence agitation	Investigate the relationship between preoperative emergence agitation explanation and occurrence of emergence agitation	up to 6 months after completion of the study

Collaborators and Investigators

• Sponsor: Gangnam Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2023
• Primary Completion (Estimated): October 26, 2024
• Study Completion (Estimated): October 26, 2024

Study Registration Dates

• First Submitted: November 29, 2022
• First Submitted That Met QC Criteria: December 7, 2022
• First Posted (Actual): December 16, 2022

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: emergence agitation; sevoflurane; general anesthesia; electroencephalogram
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Dyskinesias; Psychomotor Disorders; Delirium; Aberrant Motor Behavior in Dementia; Psychomotor Agitation; Emergence Delirium
• Other Study ID Numbers: 3-2022-0351

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No