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The study is designed to explore and compare the efficacy and safety of etomidate and propofol with or without analgesic for painless gastroscopy, and to provide more reliant support for implementation and promotion of comfort care.
To widely implement painless gastroscopy is required by diagnose and treatment with gastroscopy due to the large number and significant suffering of the patients. Also, development and exploration of anesthesiology will be bound to prompt the development and exploration of painless gastroscopy. However, the anesthesia risk of painless gastroscopy are usually higher than that of general anesthesia performed in operating room due to the condition, monitoring and equipments as well as the staffing for its implementation. Thus, the finding of a safe and convenient approach for general anesthesia will have a profound impact on a full promotion and implementation of comfortable care.
Etomidate, with the main advantage of little effect on circulatory and respiratory systems, and the features of rapid onset and metabolism, may be helpful to guarantee the safety of painless diagnosis and treatment, thus appropriate for the procedure with short duration of anesthesia. However, there is controversy regarding whether analgesic should be used in combination, as well as how to given the combined regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etomidate & Fentanyl | Experimental |
|
|
| Propofol & Fentanyl | Placebo Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etomidate | Drug |
| ||
| Fentanyl |
| Measure | Description | Time Frame |
|---|---|---|
| the minimum blood pressure | participants will be followed for the duration that from the beginning of the surgery to the extraction of the gastroscopy, an expected average of 2 hours | |
| the proportion of hypotension | participants will be followed for the duration that from the beginning of the surgery to the extraction of the gastroscopy, an expected average of 2 hours | |
| the minimum oxygen saturation of blood | participants will be followed for the duration that from the beginning of the surgery to the extraction of the gastroscopy, an expected average of 2 hours | |
| Time interval | the time interval that from the last administration of etomidate to when the patient leave the hospital | from the last administration of etomidate to when the patient leave the hospital |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of the side effects | the side effects include dizziness,nausea,vomit,myoclonia,injection pain,and the awareness during operation | participants will be followed for the duration from the beginning of the surgery to leaving hospital,an expected average of 4 hours |
| the cost of the experiment drug |
| Measure | Description | Time Frame |
|---|---|---|
| Other adverse events except above | participants will be followed for the duration from the beginning of the surgery to leaving hospital,an expected average of 4 hours | |
| the changes of the primary clinical symptoms | participants will be followed for the duration from the beginning of the surgery to leaving hospital,an expected average of 4 hours |
Inclusion Criteria:
Exclusion Criteria:
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 14, 2013 | |
| Unrelease | Yes | |
| Release | Nov 11, 2013 | |
| Unrelease | Yes | |
| Release | Feb 25, 2014 | |
| Reset | Apr 4, 2014 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 14, 2013 | Yes | |||
| Nov 11, 2013 |
| ID | Term |
|---|---|
| D005045 | Etomidate |
| D005283 | Fentanyl |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Propofol | Drug |
|
| the money that the participants spend from the beginning of the surgery to leaving hospital,an expected average of 4 hours |
| the abnormal laboratory examinations | participants will be followed for the duration from the beginning of the surgery to leaving hospital,an expected average of 4 hours |
| Yes |
| Feb 25, 2014 | Apr 4, 2014 |
| D010880 |
| Piperidines |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |