Acupoint Stimulation and Postoperative Sleep
- Conditions
- AnesthesiaSleep
- Interventions
- Other: transcutaneous electrical acupoint stimulation
- Registration Number
- NCT04632576
- Lead Sponsor
- Air Force Military Medical University, China
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 274
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description transcutaneous electrical acupoint stimulation transcutaneous electrical 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.
- Primary Outcome Measures
Name Time Method total sleeping time during the first postoperative night 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.
- Secondary Outcome Measures
Name Time Method Total intraoperative propofol dosage From the time of anesthetic induction to the end of the surgery the total dosage used for the anesthetic induction and maintenance
the Pittsburgh Sleep Quality Index (PSQI) questionnaire for the last month before surgery the 1 month before hospitalization The PSQI is used to indicate the sleep quality in the last 1 month.
The Athens Insomnia Scale (AIS) score from discharge from post-anesthesia care unit to 24hours later, totally 24 hours 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
the 15-item Quality of Recovery Scale (QoR-15) score from discharge from post-anesthesia care unit to 24hours later, totally 24 hours The QoR-15 score ranges from 0 to 150, and the higher the score, the better the postoperative recovery
Times for the needs of rescue analgesics from discharge from operation room to 24 hours later, totally 24 hours Times for the needs of rescue analgesics in the first 24h.
total wake time during the first 24h after surgery from discharge from post-anesthesia care unit to 24hours later, totally 24 hours] recorded on the actigraphy on the first perioperative night
the Epworth Sleepiness Scale (ESS) score from discharge from post-anesthesia care unit to 24hours later, totally 24 hours ESS scores range from 0 to 24, with higher scores indicating higher levels of sleepiness
time of intestinal recovery after surgery from discharge from the operation room to 48 hours later, totally 48 hours time to first flatus, time to food intake, catheter remove and ambulation
Total sleep time during the first 24h after surgery from discharge from post-anesthesia care unit to 24hours later, totally 24 hours total sleep time recorded on the actigraphy on the first perioperative night
Number of episodes of postoperative adverse events from discharge from the operation room to 48 hours later, totally 48 hours Number of episodes of postoperative adverse events such as nausea and vomiting, delirium, pulmonary edema, septic shock, arrhythmia, etc after surgery.
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 length of postoperative hospital stay
Trial Locations
- Locations (4)
Northwest Women's and Children's Hospital
🇨🇳Xi'an, Shaanxi, China
Xi 'an Hospital of Traditional Chinese Medicine
🇨🇳Xi'an, Shaanxi, China
The Second Affiliated Hospital of Xi 'an Jiaotong University
🇨🇳Xi'an, Shaanxi, China
the First Affiliated Hospital of the Air Force Military Medical University
🇨🇳Xi'an, Shaanxi, China