Clinical trial NCT04632576: Acupoint Stimulation and Postoperative Sleep
Official title: Effect of Transcutaneous Electrical Acupoint Stimulation on Sleeping After General Anesthesia in Gynecological Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Sleep
Keywords: anesthetics
sleep
surgery
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2020-11-17
Enrollment: 274
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: total sleeping time during the first postoperative night
timeFrame: the first postoperative night
Secondary outcomes:
measure: Total sleep time during the first 24h after surgery
timeFrame: from discharge from post-anesthesia care unit to 24hours later, totally 24 hours
measure: the Pittsburgh Sleep Quality Index (PSQI) questionnaire for the last month before surgery
timeFrame: the 1 month before hospitalization
measure: The Athens Insomnia Scale (AIS) score
timeFrame: from discharge from post-anesthesia care unit to 24hours later, totally 24 hours
measure: the Epworth Sleepiness Scale (ESS) score
timeFrame: from discharge from post-anesthesia care unit to 24hours later, totally 24 hours
measure: the 15-item Quality of Recovery Scale (QoR-15) score
timeFrame: from discharge from post-anesthesia care unit to 24hours later, totally 24 hours
measure: Total intraoperative propofol dosage
timeFrame: From the time of anesthetic induction to the end of the surgery
measure: Times for the needs of rescue analgesics
timeFrame: from discharge from operation room to 24 hours later, totally 24 hours
measure: Number of episodes of postoperative adverse events
timeFrame: from discharge from the operation room to 48 hours later, totally 48 hours
measure: time of intestinal recovery after surgery
timeFrame: from discharge from the operation room to 48 hours later, totally 48 hours
measure: length of postoperative hospital stay
timeFrame: from date of randamization until the time of discharge from the hospital from any cause,assessed up to 5 days
measure: total wake time during the first 24h after surgery
timeFrame: from discharge from post-anesthesia care unit to 24hours later, totally 24 hours]
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Northwest Women's and Children's Hospital
state: Shaanxi
city: Xi'an
country: China
facility: the First Affiliated Hospital of the Air Force Military Medical University
state: Shaanxi
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi 'an Jiaotong University
state: Shaanxi
city: Xi'an
country: China
facility: Xi 'an Hospital of Traditional Chinese Medicine
state: Shaanxi
Study officials:
References:
citation: Song B, Chang Y, Li Y, Zhu J. Effects of Transcutaneous Electrical Acupoint Stimulation on the Postoperative Sleep Quality and Pain of Patients After Video-Assisted Thoracoscopic Surgery: A Prospective, Randomized Controlled Trial. Nat Sci Sleep. 2020 Oct 27;12:809-819. doi: 10.2147/NSS.S270739. eCollection 2020.