General Anesthesia Clinical Trial
Official title:
Electrophysiology Based Brain Network Study on Deep Brain Nuclei LFP and Cortical EEG During the Recovery From General Anesthesia
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 |
Verified date | May 2024 |
Source | Ruijin Hospital |
Contact | Xin Ma, MD |
Phone | 021-64370045 |
mx11507[@]rjh.com.cn | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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 .
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. |
Country | Name | City | State |
---|---|---|---|
China | Ruijin Hospital Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Ruijin Hospital |
China,
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
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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