Acupoint Stimulation and Postoperative Sleep

Study Overview
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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.

Detailed Description
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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.

Official Title
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Effect of Transcutaneous Electrical Acupoint Stimulation on Sleeping After General Anesthesia in Gynecological Laparoscopic Surgery

Conditions
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Anesthesia, Sleep

Intervention / Treatment
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* Other: transcutaneous electrical acupoint stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Patients scheduled for elective Gynecological laparoscopic surgery under general anesthesia Patients aged 18-65 years Patients with a body mass index (BMI) at 18-30kg/m2 Patients with American Society of Anesthesiologists (ASA) grades I-III Patients who provide written informed consent Exclusion Criteria 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 central nervous system and mental disease, or difficult to communicate, or unable to cooperate with the investigators. 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). Participants who had severe diseases of the cardiovascular or hematopoietic systems, or had severe hepatic or renal insufficiency kidney disease Participants with a history of alcohol or drug abuse. Pregnant or lactating women.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: transcutaneous electrical acupoint stimulation<br>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. | Other: transcutaneous electrical acupoint stimulation<br>* Electrodes will be attached on the surface of acupoints and electrical stimulation will given.<br>* Other names: TEAS;|
| No Intervention: Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total sleeping time during the first postoperative night | The primary outcome is the total sleep time on the first postoperative night according to the sleep diary monitored by actigraphy. | the first postoperative night | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total sleep time during the first 24h after surgery | total sleep time recorded on the actigraphy on the first perioperative night | from discharge from post-anesthesia care unit to 24hours later, totally 24 hours | 
| the Pittsburgh Sleep Quality Index (PSQI) questionnaire for the last month before surgery | The PSQI is used to indicate the sleep quality in the last 1 month. | the 1 month before hospitalization | 
| The Athens Insomnia Scale (AIS) score | The highest score on the Athens Scale is 24, while the lowest score is 0. The higher the score, the more serious the sleep disorder | from discharge from post-anesthesia care unit to 24hours later, totally 24 hours | 
| the Epworth Sleepiness Scale (ESS) score | ESS scores range from 0 to 24, with higher scores indicating higher levels of sleepiness | from discharge from post-anesthesia care unit to 24hours later, totally 24 hours | 
| the 15-item Quality of Recovery Scale (QoR-15) score | The QoR-15 score ranges from 0 to 150, and the higher the score, the better the postoperative recovery | from discharge from post-anesthesia care unit to 24hours later, totally 24 hours | 
| Total intraoperative propofol dosage | the total dosage used for the anesthetic induction and maintenance | From the time of anesthetic induction to the end of the surgery | 
| Times for the needs of rescue analgesics | Times for the needs of rescue analgesics in the first 24h. | from discharge from operation room to 24 hours later, totally 24 hours | 
| Number of episodes of postoperative adverse events | Number of episodes of postoperative adverse events such as nausea and vomiting, delirium, pulmonary edema, septic shock, arrhythmia, etc after surgery. | from discharge from the operation room to 48 hours later, totally 48 hours | 
| time of intestinal recovery after surgery | time to first flatus, time to food intake, catheter remove and ambulation | from discharge from the operation room to 48 hours later, totally 48 hours | 
| length of postoperative hospital stay | length of postoperative hospital stay | from date of randamization until the time of discharge from the hospital from any cause,assessed up to 5 days | 
| total wake time during the first 24h after surgery | recorded on the actigraphy on the first perioperative night | from discharge from post-anesthesia care unit to 24hours later, totally 24 hours] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anesthetics, sleep, surgery