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Completed

NCT Number: NCT06684236

Acupoint Stimulation and Postoperative Sleep in Elderly Patients

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

Postoperative Sleep

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xijing Hospital, Air Force Medical University

Xi'an, Shaanxi, 710032, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age≥65 years old
  • scheduled for abdominal surgery under general anesthesia

Exclusion criteria

  • anticipated duration of surgery longer than 5 hours or shorter than 1 hour
  • American society of anesthesiologists status over stage 3
  • 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 a history of alcohol or drug abuse
  • Participants with severe hepatic or renal insufficiency kidney disease
  • Participants with contraindications to the use of acupoint stimulation (including those with infection or injury of the skin to attach electrodes, and those with implanted electronic devices)

Treatment and study plan

Transcutaneous electrical stimulation

Other

electrical stimulation is given through electrodes attached to the skin

electrodes attachment

Other

electrodes are attached to the skin area of Neiguan acupoint, which is located on 3cm above the transverse crease of the wrist

Primary outcomes

  1. total sleeping time during the first postoperative night

    Time frame: the first postoperative night, on an average of 12 hours

Secondary outcomes

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

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

  2. The Epworth Sleepiness Scale (ESS) score at 24 hours after surgery

    Time frame: 24 hours after surgery

  3. The Athens Insomnia Scale (AIS) score at 24 hours after surgery

    Time frame: 24 hours after surgery

  4. The Athens Insomnia Scale (AIS) score at 48 hours after surgery

    Time frame: 48 hours after surgery

  5. The Epworth Sleepiness Scale (ESS) score at 48 hours after surgery

    Time frame: 48 hours after surgery

  6. The Athens Insomnia Scale (AIS) score at discharge from hospital

    Time frame: the last day before discharge from hospital, at an average of 12 hours

  7. The Epworth Sleepiness Scale (ESS) score at discharge from hospital

    Time frame: the last day before discharge from hospital, at an average of 12 hours

  8. sleep efficiency(%) during the first postoperative night

    Time frame: the first postoperative night, at an average of 12 hours

    sleep efficiency is defined as the ratio of total sleep time to time in bed

  9. duration of rapid eye movement sleep during the first postoperative night

    Time frame: the first postoperative night, at an average of 12 hours

    The unit of duration of rapid eye movement sleep is by minutes

  10. number of wake during the first postoperative night

    Time frame: the first postoperative night, at an average of 12 hours

  11. incidence of delirium during hospitalization

    Time frame: From end of surgery to discharge from hospital, assessed up to 7 days

  12. length of postoperative hospital stay

    Time frame: From end of surgery to discharge from hospital, at an average of 5 days

  13. number of needs for rescue analgesia by 24 hours after surgery

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

  14. Number of participants with major complications during hospitalization, including cardiac failure, cardiac infarction, respiratory failure

    Time frame: From end of surgery to discharge from hospital, assessed up to 7 days

  15. Scale of quality of recovery at discharge from hospital

    Time frame: the last day before discharge from hospital, at an average of 12 hours

    Scale of quality of recovery is measured by the Quality-of-recovery 15 item scale (QoR-15)

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 Elderly Patients Undergoing Abdominal Surgery

Acronym: ASIS-O

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 12, 2024
Registry last updated
Jan 6, 2026

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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