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NCT06228729 Clinical Trial

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

Endotracheal Intubation Clinical Trial

Official title:
Evaluation of the Association Between Electroencephalographic Changes and Hormonal Response to Tracheal Intubation and Surgical Stimulation in Abdominal Surgery: a Prospective Observational Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06228729
Other study ID # 2311-093-1484
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date February 1, 2024
Est. completion date December 1, 2024

Study information
Verified date January 2024
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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), one minute after surgical incision (T3), and at the end of surgery (T4). We evaluate the correlation between hormone levels (cortisol, ACTH) and EEG band power changes (alpha, beta, delta) before and after endotracheal intubation and surgical incision.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 52
Est. completion date December 1, 2024
Est. primary completion date September 1, 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Endotracheal intubation
Inserting endotracheal tube into the trachea

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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