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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | Participants are given standard regimen: 50-200mg propofol and 1 mg midazolam |
|
| Fentanyl group | Experimental | Participants are given intervention regimen: 50ug fentanyl, plus 50-200mg propofol and 1 mg midazolam. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 50-200mg propofol | Drug | participants in both groups are given standard regimen including 50-200mg propofol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | half a year |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessed by the rate of hypoxia during the procedure | Hypoxia, defined as peripheral oxygen saturation <90% for >30 seconds | half a year |
| Safety assessed by the rate of hypotention during the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| jing liu | Contact | +86-18560083755 | 1057986797@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| yanqing li, Dr. | Qilu Hospital of Shandong University | Study Chair |
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| ID | Term |
|---|---|
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D005283 | Fentanyl |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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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
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| 50ug fentanyl | Drug | participants in fentanyl group are given intervention regimen: 50ug fentanyl. |
|
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| 1 mg midazolam | Drug | participants in both groups are given standard regimen including 1 mg midazolam. |
|
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Hypotension, defined as systolic blood pressure <90 mmHg
| half a year |
| Safety assessed by the rate of hyoxemia during the procedure | Hypoxia, defined as peripheral oxygen saturation <90% for >30 seconds | half a year |
| Safety assessed by the rate of breadycardia during the procedure | Bradycardia, defined as heart rate <50 beats/min | 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 | 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 | half a year |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |