Patient SatisfactionPhase 4NCT03803449
Patient Satisfaction and Safety With Propofol Based Sedation With or Without Fentanyl for Gastrointestinal Endoscopy
A Phase 4 study testing 50-200mg propofol, 50ug fentanyl and 1 mg midazolam in people with Patient Satisfaction, run by Shandong University.
Trial summary
Patient satisfaction and safety with propofol based sedation with or without fentanyl for gastrointestinal endoscopy Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Patient Satisfaction
- What is being tested?
- 50-200mg propofol, 50ug fentanyl and 1 mg midazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2019to 30 Oct 2019
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 18 or older
- Patients scheduled for an outpatient gastrointestinal endoscopy by the principal investigator.
Who cannot join
- Patients with a history of colorectal surgery
- Patients with ASA class 4 or 5,
- Patients with pre-existing hypoxaemia (SpO2<90%),
- Patients with hypotension (SBP<90mmHg)
- Patients with bradycardia (HR<50 bpm)
- patients with severe chronic renal failure (creatinine clearance<30 ml/min)
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- patients with uncontrolled hypertension (systolic blood pressure>170 mm Hg, diastolic blood pressure>100 mm Hg)
- patients with pregnancy or lactation
- Patients hemodynamically unstable
- Patients unable to give informed consent
- Patients with a history of drug allergies;
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Patient Satisfaction and Safety With Propofol Based Sedation With or Without Fentanyl for Gastrointestinal Endoscopy :a Prospective ,Randomized ,and Cohort Study
Patient satisfaction and safety with propofol based sedation with or without fentanyl for gastrointestinal endoscopy
Read the detailed description
This study divide patients into two groups, one will be given propofol midazolam and fentanyl; another group was given propofol with midazolam without fentanyl; to observe two groups of patients blood pressure, body movement, and propofol dosage , and the difference in operator satisfaction, and how many people need to give fentanyl again; and two groups of patients after the operation of the reaction, if there are dizziness, nausea, and other adverse reactions; finally, the differences of these two schemes in different populations were analyzed, and the rationalization and individualized medication will be put forward.
- Conditions
- Patient Satisfaction
- Being tested
- 50-200mg propofol, 50ug fentanyl, 1 mg midazolam
- Keywords
- propofol, fentanyl, gastrointestinal endoscopy
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
50-200mg propofolDrug
Also called Jingan, J20110055
participants in both groups are given standard regimen including 50-200mg propofol.
50ug fentanylDrug
Also called Yichang, H42022076
participants in fentanyl group are given intervention regimen: 50ug fentanyl.
1 mg midazolamDrug
Also called Liyuexi, H10980025
participants in both groups are given standard regimen including 1 mg midazolam.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Participants are given standard regimen: 50-200mg propofol and 1 mg midazolam Receives: Drug: 50-200mg propofol; Drug: 1 mg midazolam |
| Fentanyl group | Experimental | Participants are given intervention regimen: 50ug fentanyl, plus 50-200mg propofol and 1 mg midazolam. Receives: Drug: 50-200mg propofol; Drug: 50ug fentanyl; Drug: 1 mg midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction assessed by the rate of vomit and diazzy after the procedure
Rates of vomit and diazzy of patients after the procedure between the two groups
Measured: half a year
Secondary outcomes (6)
Safety assessed by the rate of hypoxia during the procedure
Hypoxia, defined as peripheral oxygen saturation <90% for >30 seconds
Measured: half a year
Safety assessed by the rate of hypotention during the procedure
Hypotension, defined as systolic blood pressure <90 mmHg
Measured: half a year
Safety assessed by the rate of hyoxemia during the procedure
Hypoxia, defined as peripheral oxygen saturation <90% for >30 seconds
Measured: half a year
Safety assessed by the rate of breadycardia during the procedure
Bradycardia, defined as heart rate <50 beats/min
Measured: half a year
Safety assessed by the rate of required airway management during the procedure
Required airway management such as jaw lifting, mask ventilation, or tracheal intubation in severe hypoxia
Measured: half a year
Safety assessed by the rate of involuntary movement during the procedure
Involuntary movements, defined as unconscious movements requiring restraint or severe limb movement interrupting the endoscopy procedure
Measured: half a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start1 Jan 2019 (estimated)
- Primary completion30 Jul 2019 (estimated)
- Study completion30 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SatisfactionStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to group A or B. Participants of group A are given propofol midazolam and fentanyl; while participants of group B are given propofol with midazolam without fentany
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
- Investigators
- yanqing li, Dr., Study chair, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03803449
- Sponsor's protocol ID
- 2018SDU-QILU-069
- Status last verified
- Jan 2019
- First submitted
- 22 Apr 2018
- Last updated
- 14 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction and Safety With Propofol Based Sedation With or Without Fentanyl for Gastrointestinal Endoscopy :a Prospective ,Randomized ,and Cohort Study
- ClinicalTrials.gov ID
- NCT03803449
- Acronym / sponsor ID
- 2018SDU-QILU-069
- Conditions
- Patient Satisfaction
- Keywords
- propofol, fentanyl, gastrointestinal endoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 30 Jul 2019 (estimated)
- Study completion
- 30 Oct 2019 (estimated)
- First posted
- 14 Jan 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.
Patient satisfaction and safety with propofol based sedation with or without fentanyl for gastrointestinal endoscopy
Detailed description
This study divide patients into two groups, one will be given propofol midazolam and fentanyl; another group was given propofol with midazolam without fentanyl; to observe two groups of patients blood pressure, body movement, and propofol dosage , and the difference in operator satisfaction, and how many people need to give fentanyl again; and two groups of patients after the operation of the reaction, if there are dizziness, nausea, and other adverse reactions; finally, the differences of these two schemes in different populations were analyzed, and the rationalization and individualized medication will be put forward.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to group A or B. Participants of group A are given propofol midazolam and fentanyl; while participants of group B are given propofol with midazolam without fentany
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: 50-200mg propofol, Drug: 1 mg midazolamParticipants are given standard regimen: 50-200mg propofol and 1 mg midazolam |
| Fentanyl group | Experimental | Drug: 50-200mg propofol, Drug: 50ug fentanyl, Drug: 1 mg midazolamParticipants are given intervention regimen: 50ug fentanyl, plus 50-200mg propofol and 1 mg midazolam. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 18 or older
- Patients scheduled for an outpatient gastrointestinal endoscopy by the principal investigator.
Key exclusion criteria (11 listed)
- Patients with a history of colorectal surgery
- Patients with ASA class 4 or 5,
- Patients with pre-existing hypoxaemia (SpO2<90%),
- Patients with hypotension (SBP<90mmHg)
- Patients with bradycardia (HR<50 bpm)
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 |
|---|---|---|
| 50-200mg propofolAlso: Jingan, J20110055participants in both groups are given standard regimen including 50-200mg propofol. | Drug | Control group, Fentanyl group |
| 50ug fentanylAlso: Yichang, H42022076participants in fentanyl group are given intervention regimen: 50ug fentanyl. | Drug | Fentanyl group |
| 1 mg midazolamAlso: Liyuexi, H10980025participants in both groups are given standard regimen including 1 mg midazolam. | Drug | Control group, Fentanyl group |
Primary outcome
Satisfaction assessed by the rate of vomit and diazzy after the procedure
Time frame: half a year
Rates of vomit and diazzy of patients after the procedure between the two groups
6 secondary outcomes
Safety assessed by the rate of hypoxia during the procedure
Time frame: half a year
Safety assessed by the rate of hypotention during the procedure
Time frame: half a year
Safety assessed by the rate of hyoxemia during the procedure
Time frame: half a year
Safety assessed by the rate of breadycardia during the procedure
Time frame: half a year
Safety assessed by the rate of required airway management during the procedure
Time frame: half a year
Safety assessed by the rate of involuntary movement during the procedure
Time frame: half a year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 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.
yanqing li, Dr. study chair
Qilu Hospital of Shandong University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 50-200mg propofol, 50ug fentanyl and 1 mg midazolam in people with Patient Satisfaction, run by Shandong University.
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 11 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 14 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 jing liu (+86-18560083755, 1057986797@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction assessed by the rate of vomit and diazzy after the procedure (time frame: half a year). 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 14 Jan 2019.