Acupoint Stimulation and Postoperative Sleep in Elderly Patients

NCT06684236 | Completed

• 1 other identifier: XJH-A-20240627
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Sleep

Keywords

acupoint stimulation; general anesthesia; sleep; elderly patients

Outcome Measures

Primary Outcomes (1)

• total sleeping time during the first postoperative night

  the first postoperative night, on an average of 12 hours

Secondary Outcomes (15)

• Total sleep time during the first 24 hours after surgery

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

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

  24 hours after surgery

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

  24 hours after surgery

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

  48 hours after surgery

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

  48 hours after surgery

Study Arms (2)

Acupoint stimulation

EXPERIMENTAL

transcutaneous electrical acupoint stimulation is one of the many forms of acupuncture, and is a distinctive part of Chinese medicine that has been practiced in China for thousands of years. It is employed by placing electrodes on acupoint and electrical stimulation is given after anesthetic induction to the end of the surgery

Other: transcutaneous electrical stimulation; Other: electrodes attachment

Control

SHAM COMPARATOR

Electrodes are placed on same acupoints as the experimental group, and will receive the "optimal intensity test" before the anesthesia induction, but no electrical stimulation is given during the operation

Other: electrodes attachment

Interventions

transcutaneous electrical stimulation OTHER

electrical stimulation is given through electrodes attached to the skin

Acupoint stimulation

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

Acupoint stimulation; Control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (1)

Xijing Hospital, Air Force Medical University

Xi'an, Shaanxi, 710032, China

Location

Related Publications (2)

• Hsu WT, Hsu CM, Hung SC, Hung SY. Acupuncture Improves Sleep Disorders and Depression among Patients with Parkinson's Disease: A Meta-Analysis. Healthcare (Basel). 2023 Jul 17;11(14):2042. doi: 10.3390/healthcare11142042.

  PMID: 37510483 BACKGROUND

• El Iskandarani S, Sun L, Li SQ, Pereira G, Giralt S, Deng G. Acupuncture improves certain aspects of sleep in hematopoietic stem cell transplantation patients: a secondary analysis of a randomized controlled trial. Acupunct Med. 2023 Dec;41(6):319-326. doi: 10.1177/09645284231181403. Epub 2023 Jul 6.

  PMID: 37409464 BACKGROUND

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: July 5, 2024
• First Posted: November 12, 2024
• Study Start: October 23, 2024
• Primary Completion: March 3, 2025
• Study Completion: March 10, 2025
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)