Analysis of Deep Brain Nuclei LFP and Cortical EEG Signals During the Recovery From General Anesthesia

May 9, 2024 updated by: Xin Ma, MD, Ruijin Hospital

Electrophysiology Based Brain Network Study on Deep Brain Nuclei LFP and Cortical EEG During the Recovery From General Anesthesia

The correlations of deep brain nuclei firing and cerebral cortex activity during recovery from general anesthesia is unclear. In this study, the local field potential (LFP) from the deep brain nuclei and the scalp electroencephalogram (EEG) of the frontal cortex were recorded from patients undergoing deep brain stimulation (DBS) surgery during the recovery from general anesthesia, in order to explore the changes and relevance of deep brain nuclei firing and cortex activity during the recovery of consciousness from general anesthesia .

Study Overview

Detailed Description

The recovery of consciousness during the emergence from general anesthesia is an important part of general anesthesia. Previous studies have found that the recovery of consciousness is not a passive process of drug metabolism, but involves the activation of functional neural networks in the brain. However, the temporal-spatial dynamics of different brain regions, including deep brain nuclei and the cortex, during recovery from general anesthesia have not been elucidated.

At present, thanks to the perceptible function of the new generation of deep brain stimulation (DBS) equipment, the local field potential (LFP) of deep brain nuclei can be recorded in real time during the patient's recovery from general anesthesia after DBS surgery. This study will simultaneously record the electrophysiological signals of the patient's deep brain nuclei LFP and cortical EEG signals, and analyze the differences and correlations between the deep brain nuclei LFP and the cortical EEG characteristics during recovery from general anesthesia. This provides evidence for understanding how subcortical deep brain nuclei are involved in the recovery of general anesthesia, and provides clues for solving the mystery of consciousness.

Study Type

Observational

Enrollment (Estimated)

42

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Shanghai
      • Shanghai, Shanghai, China, 20025
        • Recruiting
        • Ruijin Hospital Shanghai Jiaotong University School of Medicine
        • Contact:
          • Xin Ma, MD
          • Phone Number: 666325 021-64370045

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

Patients who meet the surgical indications and voluntarily undergo DBS surgery at the Functional Neurosurgery Department of Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine from April 2024 until October 2026.

Description

Inclusion Criteria:

  • 18-75 years old
  • ASA (American Society of Anesthesiologists) classification I-III
  • Those who meet the indications for DBS surgery
  • Right-handed with normal listening and speaking abilities
  • The patient signs the informed consent form and cooperates with the researchers

Exclusion Criteria:

  • Patients with cognitive impairment [Montreal Cognitive Assessment (MoCA) score less than 26 points];
  • Patients with severe depression [Beck Depression Inventory (BDI-II) score greater than or equal to 25 points];
  • Patients with important organs dysfunction, such as heart, lungs, liver, and kidneys; or patients with unstable vital signs;
  • Patients who are expected to enter the ICU after surgery;
  • Patients who are alcoholic, alcohol dependent or drug dependent;
  • Patients who have received general anesthesia one month before surgery, patients who are known to be allergic to general anesthetics;
  • The DBS surgery exceeds 4 hours;
  • Patients who are pregnant.

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
Measure Description
Time Frame
Number of Participants With Changes in the Local Field Potential from the Deep Brain Nuclei and the Scalp Electroencephalogram of the Frontal Cortex.
Time Frame: 2 hours.
Number of participants with changes in the local field potential from the deep brain nuclei and the scalp electroencephalogram of the frontal cortex during recovery of consciousness from general anesthesia. The recovery of consciousness is defined as the patient can follow the experimenter's verbal command to open mouth and extubate the endotracheal tube.
2 hours.

Collaborators and Investigators

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

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

May 15, 2024

Primary Completion (Estimated)

October 15, 2025

Study Completion (Estimated)

October 15, 2026

Study Registration Dates

First Submitted

April 16, 2024

First Submitted That Met QC Criteria

May 1, 2024

First Posted (Actual)

May 6, 2024

Study Record Updates

Last Update Posted (Actual)

May 13, 2024

Last Update Submitted That Met QC Criteria

May 9, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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