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RecruitingNCT06400901Updated May 13, 2024

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

An observational study in Deep Brain Stimulation Surgery, Electrophysiology and General Anesthesia, sponsored by Ruijin Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-05-13.

Sponsored by Ruijin Hospital · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
42
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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 .

Read the 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.

02

Conditions studied

  • Deep Brain Stimulation Surgery
  • Electrophysiology
  • General Anesthesia
  • Consciousness, Loss of

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Keywords

  • cortex EEG
  • deep brain nuclei
  • local field potentiation
  • propofol
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
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.

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

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.
04

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
42 participants (estimated)
Patient registry
No

Interventions

  • OtherNo interventions

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

05

What researchers measure

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.

    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.

    Time frame: 2 hours.

06

Study locations

1 of 1 sites recruiting
  • Ruijin Hospital Shanghai Jiaotong University School of Medicine
    Shanghai, Shanghai 20025, China
    • Xin Ma, MD · Contact · 021-64370045
    Recruiting
07

References and documents

Publications

  • Huang Y, Hu K, Green AL, Ma X, Gillies MJ, Wang S, Fitzgerald JJ, Pan Y, Martin S, Huang P, Zhan S, Li D, Tan H, Aziz TZ, Sun B. Dynamic changes in rhythmic and arrhythmic neural signatures in the subthalamic nucleus induced by anaesthesia and tracheal intubation. Br J Anaesth. 2020 Jul;125(1):67-76. doi: 10.1016/j.bja.2020.03.014. Epub 2020 Apr 24. PubMed 32336475 ↗
  • Huang Z, Vlisides PE, Tarnal VC, Janke EL, Keefe KM, Collins MM, McKinney AM, Picton P, Harris RE, Mashour GA, Hudetz AG. Brain imaging reveals covert consciousness during behavioral unresponsiveness induced by propofol. Sci Rep. 2018 Sep 4;8(1):13195. doi: 10.1038/s41598-018-31436-z. PubMed 30181567 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT06400901
Lead sponsor
Ruijin Hospital
Responsible party
Xin Ma, MD (Attending Anesthesiologist, Ruijin Hospital) — Principal investigator
First posted
May 6, 2024
Start date
May 15, 2024 (estimated)
Primary completion
Oct 15, 2025 (estimated)
Completion
Oct 15, 2026 (estimated)
Last update
May 13, 2024

Study contacts

Xin Ma, MD
Contact
mx11507@rjh.com.cn
021-64370045 ext. 666325

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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