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

January 18, 2024 updated by: Hyun-Kyu Yoon, Seoul National University Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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), 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.

Study Type

Observational

Enrollment (Estimated)

52

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2024

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

January 18, 2024

First Submitted That Met QC Criteria

January 18, 2024

First Posted (Actual)

January 29, 2024

Study Record Updates

Last Update Posted (Actual)

January 29, 2024

Last Update Submitted That Met QC Criteria

January 18, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2311-093-1484

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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