Association Between EEG Changes and Hormonal Response to... | NCT06228729

Studies
Association Between EEG Changes and Hormonal Response to Tracheal Intubation and Surgical Stimulation

NCT06228729

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Jan 6, 2026Actual

Enrollment

52Actual

Phase

Not provided

Conditions

Abdominal Surgery
Endotracheal Intubation
Surgical Incision
Electroencephalogram

Interventions

Endotracheal intubation

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2025Actual

Primary Completion Date

Oct 28, 2025Actual

Completion Date

Nov 21, 2025Actual

First Submitted Date

Jan 18, 2024

First Submission Date that Met QC Criteria

Jan 18, 2024

First Posted Date

Jan 29, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 31, 2025

Last Update Posted Date

Jan 6, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hyun-Kyu Yoon, Clinical assistant professor, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to prospectively evaluate the relationship between changes in EEG and hormonal responses induced by endotracheal intubation and surgical incision following general anesthesia.

Detailed Description

This study aims to investigate the relationship between changes in EEG patterns and stress hormone levels in patients undergoing open abdominal surgery under general anesthesia when subjected to endotracheal intubation and surgical incision stimuli.

Hormone measurements (cortisol, ACTH) are taken at four time points: before endotracheal intubation (T1), one minute after intubation (T2), and one minute after surgical incision (T3). The investigators evaluate the correlation between hormone levels (cortisol, ACTH) and EEG band power changes (alpha, beta, delta) before and after endotracheal intubation and surgical incision.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endotracheal intubation	Procedure	Inserting endotracheal tube into the trachea

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Association between band power changes in EEG and hormone respones caused by endotracheal intubation		from the start of anesthesia induction to one minute after endotracheal intubation

Secondary Outcomes

Measure	Description	Time Frame
Association between band power changes in EEG and hormone respones caused by surgical incision		from the start of anesthesia induction to one minute after surgical incision

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1) Patients scheduled to undergo open abdominal surgery under general anesthesia with endotracheal intubation.
2) Patients requiring invasive blood pressure monitoring during surgery

Exclusion Criteria:

1) Patients transferred to the intensive care unit after surgery
2) Surgery duration of less than one hour
3) Patients with neurological underlying conditions
4) Patients on chronic use of psychotropic medications and opioid drugs
5) Emergency surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Adult patients undergoing open abdominal surgery and endotracheal intubation under general anesthesia

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul		03080	South Korea

ID	Term
D000072836	Surgical Wound

ID	Term
D014947	Wounds and Injuries

Intervention Browse Module

MeSH Terms

ID	Term
D007442	Intubation, Intratracheal

Ancestor Terms

ID	Term
D058109	Airway Management
D013812	Therapeutics
D007440	Intubation
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided