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NCT Number: NCT06400901

Analysis of Deep Brain Nuclei LFP and Cortical EEG Signals 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 .

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 20025, China

Location status: Recruiting

Location contact

Xin Ma, MD

CONTACT

021-64370045 ext. 666325

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No interventions

Other

No interventions were given to patients except for the deep brain stimulation surgery they originally planned to take

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Xin Ma, MD

CONTACT

[email protected]

021-64370045 ext. 666325

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 6, 2024
Registry last updated
May 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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