Clinical trial NCT06684236: Acupoint Stimulation and Postoperative Sleep in Elderly Patients
Official title: Effect of Transcutaneous Electrical Acupoint Stimulation on Sleeping After General Anesthesia in Elderly Patients Undergoing Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postoperative Sleep
Keywords: acupoint stimulation
general anesthesia
sleep
elderly patients
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 104
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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)

Primary outcomes:
measure: total sleeping time during the first postoperative night
timeFrame: the first postoperative night, on an average of 12 hours
Secondary outcomes:
measure: Total sleep time during the first 24 hours after surgery
timeFrame: from discharge from post-anesthesia care unit to 24 hours later, totally 24 hours
measure: The Epworth Sleepiness Scale (ESS) score at 24 hours after surgery
timeFrame: 24 hours after surgery
measure: The Athens Insomnia Scale (AIS) score at 24 hours after surgery
timeFrame: 24 hours after surgery
measure: The Athens Insomnia Scale (AIS) score at 48 hours after surgery
timeFrame: 48 hours after surgery
measure: The Epworth Sleepiness Scale (ESS) score at 48 hours after surgery
timeFrame: 48 hours after surgery
measure: The Athens Insomnia Scale (AIS) score at discharge from hospital
timeFrame: the last day before discharge from hospital, at an average of 12 hours
measure: The Epworth Sleepiness Scale (ESS) score at discharge from hospital
timeFrame: the last day before discharge from hospital, at an average of 12 hours
measure: sleep efficiency(%) during the first postoperative night
timeFrame: the first postoperative night, at an average of 12 hours
measure: duration of rapid eye movement sleep during the first postoperative night
timeFrame: the first postoperative night, at an average of 12 hours
measure: number of wake during the first postoperative night
timeFrame: the first postoperative night, at an average of 12 hours
measure: incidence of delirium during hospitalization
timeFrame: From end of surgery to discharge from hospital, assessed up to 7 days
measure: length of postoperative hospital stay
timeFrame: From end of surgery to discharge from hospital, at an average of 5 days
measure: number of needs for rescue analgesia by 24 hours after surgery
timeFrame: from discharge from operation room to 24 hours later, totally 24 hours
measure: Number of participants with major complications during hospitalization, including cardiac failure, cardiac infarction, respiratory failure
timeFrame: From end of surgery to discharge from hospital, assessed up to 7 days
measure: Scale of quality of recovery at discharge from hospital
timeFrame: the last day before discharge from hospital, at an average of 12 hours
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital, Air Force Medical University
state: Shaanxi
Study officials:
References:
citation: 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.
citation: 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.