Effect of Acupoint Stimulation on Postoperative Delirium and Electroencephalogram
NCT ID: NCT06161662
Last Updated: 2023-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
226 participants
INTERVENTIONAL
2023-12-10
2026-06-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Transcutaneous electrical stimulation
At the beginning of anesthesia induction, the electrodes are attached to the skin at the Neiguan point and Shenmen point and connected to the percutaneous acupoint electrical stimulation device (Hwato , Suzhou Medical Equipment Factory). Electrical stimulation is given.
transcutaneous electrical acupoint stimulation
Electrodes will be attached on the surface of acupoints and electrical stimulation will be given
Control
At the beginning of anesthesia induction, the electrodes are attached to the skin at the Neiguan point and the Shenmen point without stimulation
Control
Electrodes will be attached on the surface of acupoints but no stimulation will be given
Interventions
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transcutaneous electrical acupoint stimulation
Electrodes will be attached on the surface of acupoints and electrical stimulation will be given
Control
Electrodes will be attached on the surface of acupoints but no stimulation will be given
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. American Society of Anesthesiologists (ASA) classification≤ Grade III
3. Patients scheduled for elective abdominal surgery under general anesthesia
4. Informed consent
Exclusion Criteria
2. Patients with cognitive dysfunction assessed by Confusion Assessment Method before surgery
3. Patients unable to cooperate with studies, such as psychiatric disorders or difficulty in communication
4. Patients with severe hepatic and renal insufficiency
5. Patients with severe respiratory diseases
6. Patients with contraindication for transcutaneous electrical stimulation, such as implanted electrophysiological devices, skin infection and damage at acupuncture points
7. Anticipated duration of anesthesia shorter than 2 hours or postoperative hospital stay shorter than 3 days
65 Years
ALL
No
Sponsors
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Zhihong LU
OTHER
Responsible Party
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Zhihong LU
Associate professor
Locations
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the First Affiliated Hospital of the Air Force Military Medical University
Xi'an, Shaanxi, China
Countries
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Central Contacts
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Facility Contacts
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Zhihong Lu
Role: primary
References
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Guay CS, Kafashan M, Huels ER, Jiang Y, Beyoglu B, Spencer JW, Geczi K, Apakama G, Ju YS, Wildes TS, Avidan MS, Palanca BJA. Postoperative Delirium Severity and Recovery Correlate With Electroencephalogram Spectral Features. Anesth Analg. 2023 Jan 1;136(1):140-151. doi: 10.1213/ANE.0000000000006075. Epub 2022 May 13.
Feng B, Zhang Y, Luo LY, Wu JY, Yang SJ, Zhang N, Tan QR, Wang HN, Ge N, Ning F, Zheng ZL, Zhu RM, Qian MC, Chen ZY, Zhang ZJ. Transcutaneous electrical acupoint stimulation for post-traumatic stress disorder: Assessor-blinded, randomized controlled study. Psychiatry Clin Neurosci. 2019 Apr;73(4):179-186. doi: 10.1111/pcn.12810. Epub 2019 Jan 22.
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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XJH-A-20230920
Identifier Type: -
Identifier Source: org_study_id