Effect of Acupoint Stimulation on Postoperative Delirium and Electroencephalogram

NCT ID: NCT06161662

Last Updated: 2023-12-08

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

226 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-10

Study Completion Date

2026-06-01

Brief Summary

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Transcutaneous electrical acupoint stimulation (TEAS) was reported to benefit the patients undergoing surgeries by reducing anesthetics consumption and decreasing anesthesia related adverse effects. Electroencephalogram (EEG) and EEG-related indicators are important indicators reflecting the conscious state of the brain, and different anesthetic drugs and anesthesia depths cause different EEG characteristic changes. The mechanism by which TEAS improves postoperative delirium (POD) is not clear, and whether changes in EEG characteristic parameters is involved needs to be further explored. Therefore, this study aims to observe the effect of TEAS at Neiguan and Shenmen acupoint on POD in elderly patients undergoing abdominal surgery, and to explore the EEG related mechanism underlying TEAS improving POD.

Detailed Description

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Conditions

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Anesthesia Postoperative Delirium Electroencephalogram

Keywords

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Transcutaneous electrical acupoint stimulation Postoperative delirium Electroencephalogram

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators
Four or six patients were defined as a block group and the results were sealed in envelopes using computer-generated block randomisation by a researcher not involved in clinical anesthesia. After the patients were enrolled, the study nurse opened the envelope according to the corresponding enrollment number and obtained the group results.

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.

Group Type EXPERIMENTAL

transcutaneous electrical acupoint stimulation

Intervention Type OTHER

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

Group Type OTHER

Control

Intervention Type OTHER

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

Intervention Type OTHER

Control

Electrodes will be attached on the surface of acupoints but no stimulation will be given

Intervention Type OTHER

Other Intervention Names

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TEAS

Eligibility Criteria

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Inclusion Criteria

1. aged 65 years or older
2. American Society of Anesthesiologists (ASA) classification≤ Grade III
3. Patients scheduled for elective abdominal surgery under general anesthesia
4. Informed consent

Exclusion Criteria

1. Patients with severe central nervous system injury or severe cerebrovascular disease
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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhihong LU

OTHER

Sponsor Role lead

Responsible Party

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Zhihong LU

Associate professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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the First Affiliated Hospital of the Air Force Military Medical University

Xi'an, Shaanxi, China

Site Status

Countries

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China

Central Contacts

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Lu Zhihong, Ph,D

Role: CONTACT

Phone: +862984775343

Email: [email protected]

Li Mengyu, M.D

Role: CONTACT

Phone: +862984775343

Email: [email protected]

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.

Reference Type BACKGROUND
PMID: 36130079 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30565342 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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XJH-A-20230920

Identifier Type: -

Identifier Source: org_study_id