Performance of EEG During Emergence Agitation in Nasal Surgery.

Nasal Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05654311
• Other study ID #: 3-2022-0351
• Status: Recruiting
• Start date: January 2, 2023
• Est. completion date: October 26, 2024

Study information

• Verified date: April 2024
• Source: Gangnam Severance Hospital
• Contact: Young Song
• Phone: 82-2-2019-6692
• Email: NEARMYHEART[@]yuhs.ac
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: October 26, 2024
• Est. primary completion date: October 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Emergence Delirium
• Nasal Surgery
• Psychomotor Agitation

Intervention

Other:
• Nasal surgery
Nasal surgery under general anesthesia using inhalational agent (sevoflurane)

Locations

Country	Name	City	State
Korea, Republic of	Gangnam Severance Hospital Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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)
Secondary	VAS (Visual Analogue Scale)	Using a ruler, it is 11 scaled (0-10) score to assess pain.	during 30 minutes after PACU admission
Secondary	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