Performance of EEG During Emergence Agitation in Nasal Surgery.

Sponsor

Gangnam Severance Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05654311

Collaborator

(none)

Enrollment

Location

9.6

Anticipated Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Nasal Surgery	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. We check the correlation between EEG and perioperative variables.

Study Design

Study Type:

Observational

Anticipated Enrollment :

55 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jan 6, 2023

Anticipated Primary Completion Date :

Oct 26, 2023

Anticipated Study Completion Date :

Oct 26, 2023

Outcome Measures

Primary Outcome Measures

EEG band relative power measured in the frontal lobe [From the cessation of sevoflurane inhalation to the extubation of tracheal tubes]
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.
occurrence of emergence agitation [From the cessation of sevoflurane inhalation to transfer to the recovery room]
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.

Secondary Outcome Measures

HADS (Hospital Anxiety and Depression Scale) [1 day before surgery (after admission)]
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.
VAS (Visual Analogue Scale) [during 30 minutes after PACU admission]
Using a ruler, it is 11 scaled (0-10) score to assess pain.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gangnam Severance Hospital Yonsei University College of Medicine	Seoul		Korea, Republic of

Sponsors and Collaborators

Gangnam Severance Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Young Song, Associate Professor, Gangnam Severance Hospital

ClinicalTrials.gov Identifier:

NCT05654311

Other Study ID Numbers:

3-2022-0351

First Posted:

Dec 16, 2022

Last Update Posted:

Dec 27, 2022

Last Verified:

Dec 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Young Song, Associate Professor, Gangnam Severance Hospital

Additional relevant MeSH terms:

Psychomotor Agitation

Emergence Delirium

Study Results

No Results Posted as of Dec 27, 2022