Comparison of Morning Operation and Evening Operation on Postoperative Sleep Quality and Pain Under General Anesthesia

Study Overview
=================
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

Official Title
-----------------
Comparison of Morning Operation and Evening Operation on Postoperative Sleep Quality and Pain Under General Anesthesia： A Randomized Controlled Trial

Conditions
-----------------
Morning Operation, Evening Operation, Sleep Quality, General Anesthesia, Circadian Rhythm Sleep Disorder

Intervention / Treatment
-----------------
* Other: receiving operation during the day or at night


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Day group<br>42 patients scheduled for elective laparoscopic abdominal surgeries under general anesthesia were randomly assigned to receive operation in the Day Group (8:00-12:00) | Other: receiving operation during the day or at night<br>* 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)<br>|
| Other: Night group<br>42 patients scheduled for elective laparoscopic abdominal surgeries under general anesthesia were randomly assigned to receive operation in the Night Group (18:00-22:00) | Other: receiving operation during the day or at night<br>* 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)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative general anesthestic requirement | record the total dose of general anesthestic requirement during the operation | during the surgery | 
| postoperative adverse effect | record the postoperative adverse effect | 24 hours after the surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
morning operation, evening operation, sleep quality, general anesthesia, circadian rhythm