Clinical trial NCT04094376: Comparison of Morning Operation and Evening Operation on Postoperative Sleep Quality and Pain Under General Anesthesia
Official title: Comparison of Morning Operation and Evening Operation on Postoperative Sleep Quality and Pain Under General Anesthesia： A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morning Operation
Evening Operation
Sleep Quality
General Anesthesia
Circadian Rhythm Sleep Disorder
Keywords: morning operation
evening operation
sleep quality
general anesthesia
circadian rhythm
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2019-09-18
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: eighty-four patients scheduled for elective laparoscopic abdominal surgeries under general anesthesia were randomly assigned to receive operation in the Day Group (8:00-12:00) and the Night Group (18:00-22:00). The Portable Sleep Monitor (PSM) was performed on the following 3 nights: the night before surgery (Sleep1), the ﬁrst night after surgery (Sleep 2), and the third night after surgery (Sleep 3). Postoperative pain scores using visual analogue scoring scale, subjective sleep quality using the Athens Insomnia Scale, total dose of general anesthetics and postoperative adverse effect were also recorded

Eligibility criteria: 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

Primary outcomes:
measure: postoperative sleep quality of one night before surgery
timeFrame: one night before the surgery
measure: postoperative sleep quality of the first night after surgery
timeFrame: the first night after surgery
measure: postoperative sleep quality of the third night after surgery
timeFrame: the third night after surgery
Secondary outcomes:
measure: intraoperative general anesthestic requirement
timeFrame: during the surgery
measure: postoperative adverse effect
timeFrame: 24 hours after the surgery
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Shengjing hospital of China Medical University
state: Liaoning
Study officials:
affiliation: Shengjing Hospital
name: Junchao Zhu
role: STUDY_DIRECTOR
References: