General Anesthesia Clinical Trial
Official title:
Comparison of Morning Operation and Evening Operation on Postoperative Sleep Quality and Pain Under General Anesthesia: A Randomized Controlled Trial
Verified date | April 2020 |
Source | Shengjing Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
General anesthesia is a medically induced state of low reactivity consciousness involving amnesia, immobility, unconsciousness, and analgesia, which is similar to natural sleep. Its aim is to create a state of sensory deprivation to induce a lack of motor reaction to stimuli and to obtain an explicit amnesia. Some studies found that general anesthesia as an independent risk factor could result in a desynchronization of the circadian time structure and cause postoperative sleep disorders characterized by reduced rapid eye movement (REM) and slow wave sleep (SWS), which have significant deleterious impacts on postoperative outcomes, such as postoperative fatigue, severe anxiety and depression, emotional detachment and delirium, and even pain sensitivity or postoperative pain of patients.Several studies also indicated that circadian rhythms existed in human and controlled by a main internal central clock, the suprachiasmatic nuclei, located in the anterior hypothalamus, which produce and regulate biological rhythms such as sleep arousal, hormones and metabolism could also affect the dose of general anesthesics, which lead to different postoperative recoveries and may have different effects on postoperative sleep quality. Previous studies proved that postoperative sleep disturbances and poor sleep quality are associated with higher postoperative pain, changes in behavior and poor emotional well-being, which could further aggravate postoperative sleep quality. At present, there are few studies which are about the effect of circadian rhythm for different timing of surgery on intraoperative anesthestic requirement, postoperative sleep quality and pain under general anesthesia.
Status | Completed |
Enrollment | 84 |
Est. completion date | March 31, 2020 |
Est. primary completion date | January 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - age between 18 and 65 years - American Society of Anaesthesiologists (ASA) physical status I or II. Exclusion Criteria: - cardiovascular disease - long term use of analgesic - preoperative heart rate (HR) less than 50 beats/min - second- or third-degree atrioventricular block - sleep disorder - sleep apnea syndrome - history of abnormal operation or anesthesia recovery psychosis or a patient with a language communication disorder did not provide informed consent |
Country | Name | City | State |
---|---|---|---|
China | Shengjing hospital of China Medical University | Shenyang | Liaoning |
Lead Sponsor | Collaborator |
---|---|
Shengjing Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | postoperative sleep quality of one night before surgery | Use sleep monitor to test the sleep quality one night before surgery | one night before the surgery | |
Primary | postoperative sleep quality of the first night after surgery | Use sleep monitor to test the sleep quality the first night after surgery | the first night after surgery | |
Primary | postoperative sleep quality of the third night after surgery | Use sleep monitor to test the sleep quality the third night after surgery | the third night after surgery | |
Secondary | intraoperative general anesthestic requirement | record the total dose of general anesthestic requirement during the operation | during the surgery | |
Secondary | postoperative adverse effect | record the postoperative adverse effect | 24 hours after the surgery |
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