Effect of Transcutaneous Electrical Acupoint Stimulation on Sleeping After General Anesthesia in Elderly Patients Undergoing Abdominal Surgery

Air Force Military Medical University, China1 site in 1 country104 target enrollmentOctober 23, 2024

ConditionsPostoperative Sleep

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Postoperative Sleep
Sponsor: Air Force Military Medical University, China
Enrollment: 104
Locations: 1
Primary Endpoint: total sleeping time during the first postoperative night
Status: Completed
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 23, 2024

End Date

March 10, 2025

Last Updated

3 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Air Force Military Medical University, China

Responsible Party

Principal Investigator

Zhihong LU

Associate professor

Air Force Military Medical University, China

Eligibility Criteria

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)

Outcomes

Primary Outcomes

total sleeping time during the first postoperative night

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

Secondary Outcomes

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)
The Athens Insomnia Scale (AIS) score at discharge from hospital(the last day before discharge from hospital, at an average of 12 hours)
The Epworth Sleepiness Scale (ESS) score at discharge from hospital(the last day before discharge from hospital, at an average of 12 hours)
sleep efficiency(%) during the first postoperative night(the first postoperative night, at an average of 12 hours)
duration of rapid eye movement sleep during the first postoperative night(the first postoperative night, at an average of 12 hours)
number of wake during the first postoperative night(the first postoperative night, at an average of 12 hours)
incidence of delirium during hospitalization(From end of surgery to discharge from hospital, assessed up to 7 days)
length of postoperative hospital stay(From end of surgery to discharge from hospital, at an average of 5 days)
number of needs for rescue analgesia by 24 hours after surgery(from discharge from operation room to 24 hours later, totally 24 hours)
Number of participants with major complications during hospitalization, including cardiac failure, cardiac infarction, respiratory failure(From end of surgery to discharge from hospital, assessed up to 7 days)
Scale of quality of recovery at discharge from hospital(the last day before discharge from hospital, at an average of 12 hours)