Acupoint Stimulation and Postoperative Sleep

Anesthesia Clinical Trial

— ASIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04632576
• Other study ID #: XJH-A-20220325
• Status: Completed
• Phase: N/A
• Start date: June 2, 2023
• Est. completion date: January 28, 2024

Study information

• Verified date: April 2024
• Source: Air Force Military Medical University, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 274
• Est. completion date: January 28, 2024
• Est. primary completion date: January 23, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Sleep

Intervention

Other:
• transcutaneous electrical acupoint stimulation
Electrodes will be attached on the surface of acupoints and electrical stimulation will given.

Locations

Country	Name	City	State
China	Northwest Women's and Children's Hospital	Xi'an	Shaanxi
China	the First Affiliated Hospital of the Air Force Military Medical University	Xi'an	Shaanxi
China	The Second Affiliated Hospital of Xi 'an Jiaotong University	Xi'an	Shaanxi
China	Xi 'an Hospital of Traditional Chinese Medicine	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Air Force Military Medical University, China

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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]