Acupoint Stimulation and Postoperative Sleep in Elderly Patients (ASIS-O)

Air Force Military Medical University of People's Liberation Army

Status: Completed

Conditions: Postoperative Sleep

Treatments: Other: electrodes attachment; Other: transcutaneous electrical stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06684236

XJH-A-20240627

Details and patient eligibility

About

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.

Enrollment: 104 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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104 participants in 2 patient groups

Acupoint stimulation

Experimental group

Description:

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

Treatment:

Other: transcutaneous electrical stimulation

Other: electrodes attachment

Control

Sham Comparator group

Description:

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

Treatment:

Other: electrodes attachment