A Phase 4 interventional study of 50-200mg propofol and 50ug fentanyl in Patient Satisfaction, sponsored by Shandong University. Status unknown. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-14.
Sponsored by Shandong University · Phase 4, Interventional, and Health services research
Patient satisfaction and safety with propofol based sedation with or without fentanyl for gastrointestinal endoscopy
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.
Shandong University is the lead sponsor of 284 studies on the registry; 59 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants are given standard regimen: 50-200mg propofol and 1 mg midazolam
Drug: 50-200mg propofol · Drug: 1 mg midazolam
Participants are given intervention regimen: 50ug fentanyl, plus 50-200mg propofol and 1 mg midazolam.
Drug: 50-200mg propofol · Drug: 50ug fentanyl · Drug: 1 mg midazolam
participants in both groups are given standard regimen including 50-200mg propofol.
Also known as: Jingan, J20110055
participants in fentanyl group are given intervention regimen: 50ug fentanyl.
Also known as: Yichang, H42022076
participants in both groups are given standard regimen including 1 mg midazolam.
Also known as: Liyuexi, H10980025
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
Time frame: half a year
Safety assessed by the rate of hypoxia during the procedure
Hypoxia, defined as peripheral oxygen saturation \<90% for \>30 seconds
Time frame: half a year
Safety assessed by the rate of hypotention during the procedure
Hypotension, defined as systolic blood pressure \<90 mmHg
Time frame: half a year
Safety assessed by the rate of hyoxemia during the procedure
Hypoxia, defined as peripheral oxygen saturation \<90% for \>30 seconds
Time frame: half a year
Safety assessed by the rate of breadycardia during the procedure
Bradycardia, defined as heart rate \<50 beats/min
Time frame: 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
Time frame: 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
Time frame: half a year
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Shandong University