Acupoint Stimulation and Postoperative Sleep in Elderly Patients
Not Applicable
Not yet recruiting
- Conditions
- Postoperative Sleep
- Registration Number
- NCT06684236
- Lead Sponsor
- Air Force Military Medical University, China
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 104
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method total sleeping time during the first postoperative night the first postoperative night, on an average of 12 hours
- Secondary Outcome Measures
Name Time Method 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 sleep efficiency is defined as the ratio of total sleep time to time in bed
duration of rapid eye movement sleep during the first postoperative night the first postoperative night, at an average of 12 hours The unit of duration of rapid eye movement sleep is by minutes
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 Scale of quality of recovery is measured by the Quality-of-recovery 15 item scale (QoR-15)
Trial Locations
- Locations (1)
Xijing Hospital, Air Force Medical University
🇨🇳Xi'an, Shaanxi, China