Morning InspectionsNCT04879771
Comparison of Receiving Painless Gastrointestinal Endoscopy in the Morning or Afternoon on Postoperative Sleep Quality
An observational study of Morning Inspections and Afternoon Inspections, run by Shengjing Hospital at 1 site in China.
Trial summary
Gastrointestinal endoscopy (GIE) are important examinations for screening, diagnosing, and treating a variety of gastrointestinal diseases. Specifically, endoscopy is one of the best surveillance tools for early detection of several cancers, GIE is increasingly being used because of government support for cancer… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Morning Inspections, Afternoon Inspections, Sleep Quality
- What is being tested?
- Receive gastrointestinal endoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 7 May 2021to 31 Dec 2021
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who received gastrointestinal endoscopy under general anesthesia at Shengjing Hospital of China Medical University were enrolled in this study
Who may be able to join
- age between 18 and 65 years,
- ASA physical status of I or II.
Who cannot join
- presence of sleep disorders
- pain syndrome
- cardiovascular disease
- sleep apnea syndrome
- psychosis
- history of opioid usage
Show all 9Show fewer
- history of abnormal operation or anesthesia recovery
- unwillingness to provide informed consent
- patient with a language communication disorder.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shengjing Hospital
Shenyang, Liaoning, 110004
Junchao Zhu, +8618940257257, zhujunchao1@hotmail.com
About this study
Gastrointestinal endoscopy (GIE) are important examinations for screening, diagnosing, and treating a variety of gastrointestinal diseases. Specifically, endoscopy is one of the best surveillance tools for early detection of several cancers, GIE is increasingly being used because of government support for cancer screening and growing interest in preventive medicine. But some patients refuse endoscopic examinations because of fear and anxiety of discomfort during the procedure. Sedatives is increasingly used in GIE these years to reduce the anxiety and discomfort of patients and increase patient satisfaction. Sedatives also minimize the risk of patient injury during GIE and provide ideal working conditions for endoscopists to improve patients' satisfaction with surgery. Sedation can be divided into four levels: minimal sedation (anxiolysis), conscious sedation, deep sedation, and general anesthesia. A combination of benzodiazepines and opiates (midazolam and fentanyl), the medications used most commonly by gastroenterologists for procedural sedation, provides adequate analgesia and sedation during colonoscopy. Besides above, propofol is an intravenously administered hypnotic drug used for induction and maintenance of general anaesthesia and is also used in procedural sedation. Nowadays, propofol sedation is preferred by more and more endoscopists for colonoscopy procedures with its perceived benefits of rapid postprocedure drug clearance, improved patient comfort and rapid recovery/discharge when compared to conventional sedation. And propofol provided more rapid recovery than midazolam, it has the merit of post-procedure neuropsychologic function over midazolam. Previous studies have found that general anesthesia, as an independent risk factor, may lead to desynchronization of the circadian rhythm, which could result in postoperative sleep disorders characterized by reduced rapid eye movement (REM) and slow-wave sleep (SWS). Postoperative sleep disorders could cause serious adverse effects on postoperative outcomes, such as postoperative fatigue, severe anxiety and depression, emotional detachment and delirium, and even increased pain sensitivity or postoperative pain in patients. Previous studies have found that general anesthesia, as an independent risk factor, may lead to desynchronization of the circadian rhythm, which could result in postoperative sleep disorders characterized by reduced rapid eye movement (REM) and slow-wave sleep (SWS). Postoperative sleep disorders could cause serious adverse effects on postoperative outcomes, such as postoperative fatigue, severe anxiety and depression, emotional detachment and delirium, and even increased pain sensitivity or postoperative pain in patients. At present, there are few studies that have assessed the effect of circadian rhythm during different timings of gastrointestinal endoscopy on postoperative sleep quality, and pain under general anesthesia.
Based on these considerations, we sought to answer the questions in this study:
- What is the impact of morning operation and evening operation on the intraoperative anesthetic requirement under general anesthesia?
- What are the effects of different timings of surgery on the postoperative sleep quality and pain under general anesthesia?
- Conditions
- Morning Inspections, Afternoon Inspections, Sleep Quality, Gastrointestinal Endoscopy, Pain, General Anesthesia
- Being tested
- Receive gastrointestinal endoscopy
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Receive gastrointestinal endoscopyProcedure or surgery
patients receive gastrointestinal endoscopy in the morning or afternoon
| Study group | Role | What they receive |
|---|---|---|
| Morning GIE | Not described Receives: Procedure: Receive gastrointestinal endoscopy | |
| Afternoon GIE | Not described Receives: Procedure: Receive gastrointestinal endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative sleep quality
assess sleep quality by using the Athens insomnia scale Total AIS scores range from 0 to 24 points. A total score of ≥ 6 points indicates a diagnosis of insomnia
Measured: first night after inspections
postoperative sleep quality
assess sleep quality by using the Athens insomnia scale Total AIS scores range from 0 to 24 points. A total score of ≥ 6 points indicates a diagnosis of insomnia
Measured: second night after inspections
Secondary outcomes (2)
postoperative pain score
assess pain level by using VAS score Postoperative pain scores were evaluated by the visual analog scale (VAS) score,15 where 0 indicates painlessness, and 10 indicates severe pain. The VAS score was measured at 1, 6, 12, and 24 hours postoperatively
Measured: 24 hours after surgery
postoperative adverse effects
assess postoperative adverse effects
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start7 May 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morning InspectionsStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
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
- NCT04879771
- Sponsor's protocol ID
- GIE and sleep
- Status last verified
- May 2021
- First submitted
- 7 May 2021
- Last updated
- 10 May 2021
- 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 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Receiving Painless Gastrointestinal Endoscopy in the Morning or Afternoon on Postoperative Sleep Quality
- ClinicalTrials.gov ID
- NCT04879771
- Acronym / sponsor ID
- GIE and sleep
- Conditions
- Morning Inspections, Afternoon Inspections, Sleep Quality, Gastrointestinal Endoscopy, Pain, General Anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 7 May 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 10 May 2021 (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.
Gastrointestinal endoscopy (GIE) are important examinations for screening, diagnosing, and treating a variety of gastrointestinal diseases. Specifically, endoscopy is one of the best surveillance tools for early detection of several cancers, GIE is increasingly being used because of government support for cancer screening and growing interest in preventive medicine. But some patients refuse endoscopic examinations because of fear and anxiety of discomfort during the procedure. Sedatives is increasingly used in GIE these years to reduce the anxiety and discomfort of patients and increase patient satisfaction. Sedatives also minimize the risk of patient injury during GIE and provide ideal working conditions for endoscopists to improve patients' satisfaction with surgery. Sedation can be divided into four levels: minimal sedation (anxiolysis), conscious sedation, deep sedation, and general anesthesia. A combination of benzodiazepines and opiates (midazolam and fentanyl), the medications used most commonly by gastroenterologists for procedural sedation, provides adequate analgesia and sedation during colonoscopy. Besides above, propofol is an intravenously administered hypnotic drug used for induction and maintenance of general anaesthesia and is also used in procedural sedation. Nowadays, propofol sedation is preferred by more and more endoscopists for colonoscopy procedures with its perceived benefits of rapid postprocedure drug clearance, improved patient comfort and rapid recovery/discharge when compared to conventional sedation. And propofol provided more rapid recovery than midazolam, it has the merit of post-procedure neuropsychologic function over midazolam. Previous studies have found that general anesthesia, as an independent risk factor, may lead to desynchronization of the circadian rhythm, which could result in postoperative sleep disorders characterized by reduced rapid eye movement (REM) and slow-wave sleep (SWS). Postoperative sleep disorders could cause serious adverse effects on postoperative outcomes, such as postoperative fatigue, severe anxiety and depression, emotional detachment and delirium, and even increased pain sensitivity or postoperative pain in patients. Previous studies have found that general anesthesia, as an independent risk factor, may lead to desynchronization of the circadian rhythm, which could result in postoperative sleep disorders characterized by reduced rapid eye movement (REM) and slow-wave sleep (SWS). Postoperative sleep disorders could cause serious adverse effects on postoperative outcomes, such as postoperative fatigue, severe anxiety and depression, emotional detachment and delirium, and even increased pain sensitivity or postoperative pain in patients. At present, there are few studies that have assessed the effect of circadian rhythm during different timings of gastrointestinal endoscopy on postoperative sleep quality, and pain under general anesthesia.
Based on these considerations, we sought to answer the questions in this study:
- What is the impact of morning operation and evening operation on the intraoperative anesthetic requirement under general anesthesia?
- What are the effects of different timings of surgery on the postoperative sleep quality and pain under general anesthesia?
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morning GIE | – | Procedure: Receive gastrointestinal endoscopy |
| Afternoon GIE | – | Procedure: Receive gastrointestinal endoscopy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who received gastrointestinal endoscopy under general anesthesia at Shengjing Hospital of China Medical University were enrolled in this study
Key inclusion criteria (2 listed)
- age between 18 and 65 years,
- ASA physical status of I or II.
Key exclusion criteria (9 listed)
- presence of sleep disorders
- pain syndrome
- cardiovascular disease
- sleep apnea syndrome
- psychosis
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 |
|---|---|---|
| Receive gastrointestinal endoscopypatients receive gastrointestinal endoscopy in the morning or afternoon | Procedure or surgery | Afternoon GIE, Morning GIE |
Primary outcome
postoperative sleep quality
Time frame: first night after inspections
assess sleep quality by using the Athens insomnia scale Total AIS scores range from 0 to 24 points. A total score of ≥ 6 points indicates a diagnosis of insomnia
postoperative sleep quality
Time frame: second night after inspections
assess sleep quality by using the Athens insomnia scale Total AIS scores range from 0 to 24 points. A total score of ≥ 6 points indicates a diagnosis of insomnia
2 secondary outcomes
postoperative pain score
Time frame: 24 hours after surgery
postoperative adverse effects
Time frame: 24 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
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?
An observational study of Morning Inspections and Afternoon Inspections, 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 9 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: status not confirmed, as of the sponsor's last update on 10 May 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Junchao Zhu (+8618940257257, zhujunchao1@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative sleep quality (time frame: first night after inspections). The study lists 2 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 10 May 2021.