Comparison of Morning Operation and Evening Operation on Postoperative Sleep Quality and Pain Under General Anesthesia
Primary Purpose
Morning Operation, Evening Operation, Sleep Quality
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
receiving operation during the day or at night
Sponsored by
About this trial
This is an interventional other trial for Morning Operation focused on measuring morning operation, evening operation, sleep quality, general anesthesia, circadian rhythm
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
Sites / Locations
- Shengjing hospital of China Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Day group
Night group
Arm Description
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)
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)
Outcomes
Primary Outcome Measures
postoperative sleep quality of one night before surgery
Use sleep monitor to test the sleep quality one night before surgery
postoperative sleep quality of the first night after surgery
Use sleep monitor to test the sleep quality 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
Secondary Outcome Measures
intraoperative general anesthestic requirement
record the total dose of general anesthestic requirement during the operation
postoperative adverse effect
record the postoperative adverse effect
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04094376
Brief Title
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
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
September 20, 2019 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shengjing Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morning Operation, Evening Operation, Sleep Quality, General Anesthesia, Circadian Rhythm Sleep Disorder
Keywords
morning operation, evening operation, sleep quality, general anesthesia, circadian rhythm
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Day group
Arm Type
Other
Arm Description
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)
Arm Title
Night group
Arm Type
Other
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
receiving operation during the day or at night
Intervention 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)
Primary Outcome Measure Information:
Title
postoperative sleep quality of one night before surgery
Description
Use sleep monitor to test the sleep quality one night before surgery
Time Frame
one night before the surgery
Title
postoperative sleep quality of the first night after surgery
Description
Use sleep monitor to test the sleep quality the first night after surgery
Time Frame
the first night after surgery
Title
postoperative sleep quality of the third night after surgery
Description
Use sleep monitor to test the sleep quality the third night after surgery
Time Frame
the third night after surgery
Secondary Outcome Measure Information:
Title
intraoperative general anesthestic requirement
Description
record the total dose of general anesthestic requirement during the operation
Time Frame
during the surgery
Title
postoperative adverse effect
Description
record the postoperative adverse effect
Time Frame
24 hours after the surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junchao Zhu
Organizational Affiliation
Shengjing Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Shengjing hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
12. IPD Sharing Statement
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Comparison of Morning Operation and Evening Operation on Postoperative Sleep Quality and Pain Under General Anesthesia
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