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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06400901
Other study ID # 2023(426)
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 15, 2024
Est. completion date October 15, 2026

Study information

Verified date May 2024
Source Ruijin Hospital
Contact Xin Ma, MD
Phone 021-64370045
Email mx11507@rjh.com.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 .


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 42
Est. completion date October 15, 2026
Est. primary completion date October 15, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
China Ruijin Hospital Shanghai Jiaotong University School of Medicine Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

References & 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 in — View Citation

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. do — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
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