Anesthesia, Sleep
Conditions
Keywords
anesthetics, sleep, surgery
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.
Interventions
OTHERtranscutaneous electrical acupoint stimulation
Electrodes will be attached on the surface of acupoints and electrical stimulation will given.
Sponsors
Air Force Military Medical University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 |
| 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 |
| 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. |
| 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 |
| 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 |
| 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 |
| 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. |
Countries
China
Outcome results
None listed