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

NCT06400901 | Recruiting

• 1 other identifier: 2023(426)
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

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

Keywords

cortex EEG; deep brain nuclei; local field potentiation; propofol

Outcome Measures

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.

  2 hours.

Interventions

No interventions OTHER

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 20025, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 32336475 RESULT

• 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.

  PMID: 30181567 RESULT

MeSH Terms

Conditions

Unconsciousness

Condition Hierarchy (Ancestors)

Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Xin Ma, MD

CONTACT

021-64370045; mx11507@rjh.com.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Anesthesiologist

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: May 6, 2024
• Study Start: May 15, 2024
• Primary Completion: October 15, 2025
• Study Completion (Estimated): October 15, 2026
• Last Updated: May 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)