EsophagogastroduodenoscopyNCT04168294
The Influence of Sedation for Endoscopy on Cognitive Function
An observational study of Esophagogastroduodenoscopy and Deep Sedation, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
It is commonly recommended that patients should refrain from driving for 24 hours after sedation for endoscopy，however，this recommendation has been queried recently．To investigate the effect of sedation on early postoperative cognitive function in patients undergoing endoscopy. Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Esophagogastroduodenoscopy, Deep Sedation, Cognition Disorders
- What is being tested?
- Propofol and endoscopy
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 14 Nov 2019to 14 Nov 2019
- 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 20 to 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: Radom select patients who undergo EGD in Renji Hospital, School of Medicine, Shanghai Jiaotong University. Patients who are recruited all received nine year compulsory education and fit for the inclusion criteria. Moreover, all patients received approval from the local institutional review board.
Who may be able to join
- The scores of MMSE are more than 26.
- The AHA grade I and II.
Who cannot join
- The AHA grade III, IV or V.
- binge drinking.
- Take sedatives, sleeping agents and some drug which may affect the study in a month.
- Psychiatric disorders.
- The dysfunction of heart, lung, liver and kidney.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Gastroenterology, Renji Hospital, Shanghai Institute of Digestive Diseases, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127
About this study
It is commonly recommended that patients should refrain from driving for 24 hours after sedation for endoscopy，however，this recommendation has been queried recently．To investigate the effect of sedation on early postoperative cognitive function in patients undergoing endoscopy.
Read the detailed description
One hundred adult patients undergoing sedative esophagogastroduodenoscopy ( EGD) were randomly recruited，and another 100 adult patients undergoing conventional（without sedation） EGD were served as controls． All patients had an education level more than 9 years． Cognitive function was assessed by Montreal Cognitive Assessment（MoCA）1 week before EGD exam, 10 mins before propofol sedation or the beginning of endoscopic procedure, 30mins after EGD exam, and 2 week after exam.
- Being tested
- Propofol, endoscopy
- Keywords
- Esophagogastroduodenoscopy, Deep Sedation, Cognition Disorders, Patient Discharge, Automobile Driving
- Medical subject headings
- Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
patients in sedation group will be intravenous injected propofol in bolus
endoscopyDevice
Also called Olympus Lucera Elite 290 system
endoscopy system
| Study group | Role | What they receive |
|---|---|---|
| sedation group | Patients undergo sedative esophagogastroduodenoscopy (EGD) and are intravenous injected propofol in bolus Receives: Drug: Propofol; Device: endoscopy | |
| control group | patients undergo conventional EGD Receives: Device: endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
NCT-A test outcome measure
the score of NCT-A test for each patient is not less than that in the baseline.
Measured: 30 minutes
DST test outcome measure
the score of DST for each patient is not less than that in the baseline.
Measured: 30 minutes
number cancellation test outcome measure
the score of number cancellation test for each patient is not less than that in the baseline.
Measured: 30 minutes
Secondary outcomes (2)
heart rate outcome measure
heart rate less than 50 time per minute
Measured: 5 minutes
SpO2 outcome measure
SpO2 less than 90%
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start14 Nov 2019
- Primary completion14 Nov 2019
- Study completion14 Nov 2019
Why it stopped: The number of subjects did not meet the requirements
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EsophagogastroduodenoscopyStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhizheng Ge, Shanghai Jiao Tong University School of Medicine
- Investigators
- Wei-Ping Li, Study chair, Renji Hospital, School of Medicine, Shanghai Jiao Tong University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04168294
- Sponsor's protocol ID
- rjyyxhk2017001
- Status last verified
- Nov 2019
- First submitted
- 26 Sep 2018
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Sedation for Endoscopy on Cognitive Function
- ClinicalTrials.gov ID
- NCT04168294
- Acronym / sponsor ID
- rjyyxhk2017001
- Keywords
- Esophagogastroduodenoscopy, Deep Sedation, Cognition Disorders, Patient Discharge, Automobile Driving
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The number of subjects did not meet the requirements
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 14 Nov 2019 (actual)
- Primary completion
- 14 Nov 2019 (actual)
- Study completion
- 14 Nov 2019 (actual)
- First posted
- 19 Nov 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.
It is commonly recommended that patients should refrain from driving for 24 hours after sedation for endoscopy，however，this recommendation has been queried recently．To investigate the effect of sedation on early postoperative cognitive function in patients undergoing endoscopy.
Detailed description
One hundred adult patients undergoing sedative esophagogastroduodenoscopy ( EGD) were randomly recruited，and another 100 adult patients undergoing conventional（without sedation） EGD were served as controls． All patients had an education level more than 9 years． Cognitive function was assessed by Montreal Cognitive Assessment（MoCA）1 week before EGD exam, 10 mins before propofol sedation or the beginning of endoscopic procedure, 30mins after EGD exam, and 2 week after exam.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sedation group | – | Drug: Propofol, Device: endoscopyPatients undergo sedative esophagogastroduodenoscopy (EGD) and are intravenous injected propofol in bolus |
| control group | – | Device: endoscopypatients undergo conventional EGD |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Radom select patients who undergo EGD in Renji Hospital, School of Medicine, Shanghai Jiaotong University. Patients who are recruited all received nine year compulsory education and fit for the inclusion criteria. Moreover, all patients received approval from the local institutional review board.
Key inclusion criteria (2 listed)
- The scores of MMSE are more than 26.
- The AHA grade I and II.
Key exclusion criteria (5 listed)
- The AHA grade III, IV or V.
- binge drinking.
- Take sedatives, sleeping agents and some drug which may affect the study in a month.
- Psychiatric disorders.
- The dysfunction of heart, lung, liver and kidney.
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 |
|---|---|---|
| Propofolpatients in sedation group will be intravenous injected propofol in bolus | Drug | sedation group |
| endoscopyAlso: Olympus Lucera Elite 290 systemendoscopy system | Device | control group, sedation group |
Primary outcome
NCT-A test outcome measure
Time frame: 30 minutes
the score of NCT-A test for each patient is not less than that in the baseline.
DST test outcome measure
Time frame: 30 minutes
the score of DST for each patient is not less than that in the baseline.
number cancellation test outcome measure
Time frame: 30 minutes
the score of number cancellation test for each patient is not less than that in the baseline.
2 secondary outcomes
heart rate outcome measure
Time frame: 5 minutes
SpO2 outcome measure
Time frame: 5 minutes
Results and safety
The study was stopped early (reason given: The number of subjects did not meet the requirements). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Individual participant dataSharing planned: Undecided
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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.
Wei-Ping Li study chair
Renji Hospital, School of Medicine, Shanghai Jiao Tong University.
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 Esophagogastroduodenoscopy and Deep Sedation, run by Shanghai Jiao Tong University School of Medicine 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 5 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: stopped early, as of the sponsor's last update on 19 Nov 2019. 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 was stopped early (reason given: The number of subjects did not meet the requirements). Results are not available in the source record.
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?
NCT-A test outcome measure (time frame: 30 minutes). 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 19 Nov 2019; AzTrials last refreshed its copy on 30 Oct 2026.