Morning OperationNCT04094376
Comparison of Morning Operation and Evening Operation on Postoperative Sleep Quality and Pain Under General Anesthesia
A study testing receiving operation during the day or at night in people with Morning Operation and Evening Operation, run by Shengjing Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Morning Operation, Evening Operation, Sleep Quality
- What is being tested?
- receiving operation during the day or at night
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2019to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 18 and 65 years
- American Society of Anaesthesiologists (ASA) physical status I or II.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Shengjing hospital of China Medical University
Shenyang, Liaoning, 110004
About this study
Official title: Comparison of Morning Operation and Evening Operation on Postoperative Sleep Quality and Pain Under General Anesthesia： A Randomized Controlled Trial
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.
Read the 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
- Conditions
- Morning Operation, Evening Operation, Sleep Quality, General Anesthesia, Circadian Rhythm Sleep Disorder
- Being tested
- receiving operation during the day or at night
- Keywords
- morning operation, evening operation, sleep quality, general anesthesia, circadian rhythm
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Sleep Disorders, Circadian Rhythm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
receiving operation during the day or at nightOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Day group | Other | 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) Receives: Other: receiving operation during the day or at night |
| Night group | Other | 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) Receives: Other: receiving operation during the day or at night |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative sleep quality of one night before surgery
Use sleep monitor to test the sleep quality one night before surgery
Measured: 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
Measured: 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
Measured: the third night after surgery
Secondary outcomes (2)
intraoperative general anesthestic requirement
record the total dose of general anesthestic requirement during the operation
Measured: during the surgery
postoperative adverse effect
record the postoperative adverse effect
Measured: 24 hours after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2019
- Study start20 Sep 2019
- Primary completion31 Jan 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morning OperationStudies of the same condition, open and under way.
- More trials run by Shengjing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanchao Yang, Shengjing Hospital
- Investigators
- Junchao Zhu, Study director, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04094376
- Sponsor's protocol ID
- circadian rhythm and sleep
- Status last verified
- Apr 2020
- First submitted
- 17 Sep 2019
- Last updated
- 24 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Morning Operation and Evening Operation on Postoperative Sleep Quality and Pain Under General Anesthesia： A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04094376
- Acronym / sponsor ID
- circadian rhythm and sleep
- Conditions
- Morning Operation, Evening Operation, Sleep Quality, General Anesthesia, Circadian Rhythm Sleep Disorder
- Keywords
- morning operation, evening operation, sleep quality, general anesthesia, circadian rhythm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 20 Sep 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 18 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Day group | Other | Other: receiving operation during the day or at night42 patients scheduled for elective laparoscopic abdominal surgeries under general anesthesia were randomly assigned to receive operation in the Day Group (8:00-12:00) |
| Night group | Other | Other: receiving operation during the day or at night42 patients scheduled for elective laparoscopic abdominal surgeries under general anesthesia were randomly assigned to receive operation in the Night Group (18:00-22:00) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age between 18 and 65 years
- American Society of Anaesthesiologists (ASA) physical status I or II.
Key exclusion criteria (7 listed)
- cardiovascular disease
- long term use of analgesic
- preoperative heart rate (HR) less than 50 beats/min
- second- or third-degree atrioventricular block
- sleep disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| receiving operation during the day or at nighteighty-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) | Other | Day group, Night group |
Primary outcome
postoperative sleep quality of one night before surgery
Time frame: one night before the surgery
Use sleep monitor to test the sleep quality one night before surgery
postoperative sleep quality of the first night after surgery
Time frame: 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
Time frame: the third night after surgery
Use sleep monitor to test the sleep quality the third night after surgery
2 secondary outcomes
intraoperative general anesthestic requirement
Time frame: during the surgery
postoperative adverse effect
Time frame: 24 hours after the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junchao Zhu study director
Shengjing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing receiving operation during the day or at night in people with Morning Operation and Evening Operation, run by Shengjing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative sleep quality of one night before surgery (time frame: one night before the surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2020.