Acupoint Stimulation and Postoperative Sleep (ASIS)

Air Force Military Medical University of People's Liberation Army

Status: Completed

Conditions: Sleep; Anesthesia

Treatments: Other: transcutaneous electrical acupoint stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04632576

XJH-A-20220325

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.

Full description

Sleep is a necessary, naturally occurring physiologic state that is especially critical to cognition and physical functioning in surgical settings.Poor postoperative sleep is associated with many significant deleterious effects. Therefore, improving overall sleep during postoperative rehabilitation is desirable.

Transcutaneous electrical acupoint stimulation (TEAS) is a non-invasive acupuncture therapy combining the transcutaneous electrical nerve stimulation, and has been utilized in clinical settings for many years. Previous study demonstrated that TEAS combined with anesthesia can upregulate the levels of melatonin and aminobutyric acid to relief central inhibition, thus improve patients'sleep efficiency, prolong total sleep time (TST) and promote sleep quality.

The current study is to examine the effect of perioperative TEAS on subjective and objective sleep quality among patients who have undergone Gynecological laparoscopic surgery under general anesthesia.

Enrollment: 274 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. Patients scheduled for elective Gynecological laparoscopic surgery under general anesthesia
2. Patients aged 18-65 years
3. Patients with a body mass index (BMI) at 18-30kg/m2
4. Patients with American Society of Anesthesiologists (ASA) grades I-III
5. Patients who provide written informed consent

Exclusion Criteria

1. Participants with sleep apnea or moderate and severe obstructive sleep apnea syndrome (defined by Apnea Hypopnea Index (AHI))
2. Participants with preoperative sleep disturbances (diagnostic criteria of sleep disturbances according to the International Classification of Sleep Disorders, Third Edition (ICSD-3));
3. Participants with central nervous system and mental disease, or difficult to communicate, or unable to cooperate with the investigators.
4. Participants with contraindications to the use of electroacupuncture (including those with infection or injury of the skin to attach electrodes, and those with implanted electronic devices).
5. Participants who had severe diseases of the cardiovascular or hematopoietic systems, or had severe hepatic or renal insufficiency kidney disease
6. Participants with a history of alcohol or drug abuse. Pregnant or lactating women.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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274 participants in 2 patient groups

transcutaneous electrical 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 acupoint stimulation

Control

No Intervention 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.