- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06400901
Analysis of Deep Brain Nuclei LFP and Cortical EEG Signals During the Recovery From General Anesthesia
Electrophysiology Based Brain Network Study on Deep Brain Nuclei LFP and Cortical EEG During the Recovery From General Anesthesia
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Xin Ma, MD
- Phone Number: 666325 021-64370045
- Email: mx11507@rjh.com.cn
Study Locations
-
-
Shanghai
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Shanghai, Shanghai, China, 20025
- Recruiting
- Ruijin Hospital Shanghai Jiaotong University School of Medicine
-
Contact:
- Xin Ma, MD
- Phone Number: 666325 021-64370045
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
2 hours.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023(426)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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