Acupoint Stimulation and Postoperative Sleep in Elderly Patients

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

COMPLETED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-23

Study Completion Date

2025-03-10

Brief Summary

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Sleeping model can be affected after surgery. Anesthetics may be involved in the change. The changing of sleeping mode may exert adverse effect on postoperative recovery. Acupuncture and related techniques has been used for treating sleeping disorder. In this study, the effect of transcutaneous electrical acupoint stimulation on sleeping model after general anesthesia will be observed.

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Detailed Description

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Conditions

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Postoperative Sleep

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Acupoint stimulation

transcutaneous electrical acupoint stimulation is one of the many forms of acupuncture, and is a distinctive part of Chinese medicine that has been practiced in China for thousands of years. It is employed by placing electrodes on acupoint and electrical stimulation is given after anesthetic induction to the end of the surgery

Group Type EXPERIMENTAL

transcutaneous electrical stimulation

Intervention Type OTHER

electrical stimulation is given through electrodes attached to the skin

electrodes attachment

Intervention Type OTHER

electrodes are attached to the skin area of Neiguan acupoint, which is located on 3cm above the transverse crease of the wrist

Control

Electrodes are placed on same acupoints as the experimental group, and will receive the "optimal intensity test" before the anesthesia induction, but no electrical stimulation is given during the operation

Group Type SHAM_COMPARATOR

electrodes attachment

Intervention Type OTHER

electrodes are attached to the skin area of Neiguan acupoint, which is located on 3cm above the transverse crease of the wrist

Interventions

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transcutaneous electrical stimulation

electrical stimulation is given through electrodes attached to the skin

Intervention Type OTHER

electrodes attachment

electrodes are attached to the skin area of Neiguan acupoint, which is located on 3cm above the transverse crease of the wrist

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age≥65 years old
* scheduled for abdominal surgery under general anesthesia

Exclusion Criteria

* anticipated duration of surgery longer than 5 hours or shorter than 1 hour
* American society of anesthesiologists status over stage 3
* Participants with sleep apnea or moderate and severe obstructive sleep apnea syndrome (defined by Apnea Hypopnea Index (AHI))
* Participants with preoperative sleep disturbances (diagnostic criteria of sleep disturbances according to the International Classification of Sleep Disorders, Third Edition (ICSD-3))
* Participants with a history of alcohol or drug abuse
* Participants with severe hepatic or renal insufficiency kidney disease
* Participants with contraindications to the use of acupoint stimulation (including those with infection or injury of the skin to attach electrodes, and those with implanted electronic devices)

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No