Clinical trial NCT04124679: Effect of Transcutaneous Electrical Acupoint Stimulation on Sleep After Thoracoscopic Surgery
Official title: Effect of Transcutaneous Electrical Acupoint Stimulation on Sleep After Thoracoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transcutaneous Electrical Acupoint Stimulation
Thoracoscopic Surgery
Postoperative Sleep Quality
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2019-10-11
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: General anesthesia is a medically induced state of low reactivity consciousness which is similar to natural sleep.Some studies found that general anesthesia as an independent risk factor could result in a desynchronization of the circadian time structure and cause postoperative sleep disorders characterized by reduced rapid eye movement (REM) and slow wave sleep (SWS),which have signiﬁcant deleterious impacts on postoperative outcomes, such as postoperative fatigue, severe anxiety and depression, emotional detachment and delirium, and even pain sensitivity or postoperative pain of patients.Acupuncture can regulate plant nerve activity by increasing slow-wave sleep time to improve sleep quality.The results of polysomnography monitoring showed that the sleep latency, total sleep time, awakening index and sleep quality were all significant improved after acupuncture treatment.And transcutaneous electrical acupoint stimulation（TAES） works by stimulating Shu yu acupoints, which is more convenient than the normal electric acupuncture. The purpose of this paper is to study the effect of TAES on sleep after thoracoscopic surgery

Detailed description: In TEAS group, an experienced acupuncturist performed 30 minutes of TEAS treatment at the HT7 (Shenmen) and Neiguan (PC6) acupoints on bilateral side, which were identiﬁed in accordance with the TCM anatomic localizations on the first night before surgery by a stimulator (Hwato Electronic Acupuncture Treatment Instrument, model no.: SDZ-II; Suzhou Medical Appliances Co. Ltd, Suzhou, China). And after surgery, ST36 (Zusanli) and LI4 (Hegu) acupoints were added for the effect of relieving postoperative complications. 30 minutes of TEAS treatment was also performed on bilateral side by an experienced acupuncturist at the Neiguan (PC6), HT7 (Shenmen), ST36 (Zusanli) and LI4 (Hegu) acupoints on the first three nights after surgery. The TEAS was standardized before each treatment and was set at 2/10 HZ, which has been documented as the most effective frequency. The optimal intensity is from 6 to 15mA, which was adjusted according to individual maximum tolerance to maintain a slight twitching of the regional muscles. Patients in the control group were attached the gel electrodes at the sham acupoints. The acupuncture points were to be stimulated by microcurrents generated by a special electrical device, which the patients may only experience a mild electric current sensation or nothing at all.

Eligibility criteria: Inclusion Criteria:

* ASA ( American Society of Anesthesiologists):I-II
* age for 18-75 years

Exclusion Criteria:

* History of central nervous system and mental illness
* use of sedatives or antidepressants
* infection or wound at the percutaneous acupuncture point
* unwilling to participate

Primary outcomes:
measure: sleep quality tested by sleep monitor of the second night before the operation
timeFrame: second night before the surgery
measure: sleep quality tested by sleep monitor of the first night before the operation
timeFrame: the first night before surgery
measure: sleep quality tested by sleep monitor of the first night after the operation
timeFrame: the first night after the operation
measure: sleep quality of the tested by sleep monitor on the third night after the operation
timeFrame: the third night after the operation
Secondary outcomes:
measure: subjective sleep quality: Athens Insomnia Scale
timeFrame: one night before the operation and the first and third night after the operation
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Shengjing hospital of China Medical university
state: Liaoning
Study officials:
affiliation: Shengjing Hospital
name: Junchao h Zhu
role: STUDY_DIRECTOR
References: