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NCT Number: NCT04632576

Acupoint Stimulation and Postoperative Sleep

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.

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Key information

Conditions

Anesthesia Sleep

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Northwest Women's and Children's Hospital, Xi'an, Shaanxi, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

transcutaneous electrical acupoint stimulation

Other

Electrodes will be attached on the surface of acupoints and electrical stimulation will given.

Other names: TEAS

Primary outcomes

  1. total sleeping time during the first postoperative night

    Time frame: 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 outcomes

  1. Total sleep time during the first 24h after surgery

    Time frame: 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

  2. the Pittsburgh Sleep Quality Index (PSQI) questionnaire for the last month before surgery

    Time frame: the 1 month before hospitalization

    The PSQI is used to indicate the sleep quality in the last 1 month.

  3. The Athens Insomnia Scale (AIS) score

    Time frame: 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

  4. the Epworth Sleepiness Scale (ESS) score

    Time frame: 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

  5. the 15-item Quality of Recovery Scale (QoR-15) score

    Time frame: 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

  6. Total intraoperative propofol dosage

    Time frame: From the time of anesthetic induction to the end of the surgery

    the total dosage used for the anesthetic induction and maintenance

  7. Times for the needs of rescue analgesics

    Time frame: from discharge from operation room to 24 hours later, totally 24 hours

    Times for the needs of rescue analgesics in the first 24h.

  8. Number of episodes of postoperative adverse events

    Time frame: 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.

  9. time of intestinal recovery after surgery

    Time frame: 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

  10. length of postoperative hospital stay

    Time frame: 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

  11. total wake time during the first 24h after surgery

    Time frame: from discharge from post-anesthesia care unit to 24hours later, totally 24 hours]

    recorded on the actigraphy on the first perioperative night

Sponsors and collaborators

Lead sponsor

Air Force Military Medical University, China

Other

Registry information

Official study title

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

Acronym: ASIS

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 17, 2020
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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