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Gastroscopy, as a conventional examination for gastrointestinal tract disease, plays a very important role especially in early diagnosis and differential diagnosis of esophageal and gastric carcinoma. However, conventional gastroscopy is associated with several adverse effects (including throat discomfort, breath-holding, nausea, vomiting, laryngeal spasm and increased heart rate) due to which some patients are intolerant to this examination or even refuse the procedure due to fear of these effects. Recently, painless gastroscopy has been applied increasingly widely in outpatients to meet the increasing needs for comfortable medical care.
Painless gastroscopy is commonly performed under general anesthesia without establishing an artificial airway. This is associated with an even higher anesthetic risk than general anesthesia in the operating room due to more basic patient monitoring and life-supporting equipment, only one anesthetist to perform anesthesia, fatigue in anesthesia, the requirement for a high turnover rate, as well as limited understanding of a patient's condition. Therefore, the availability of sedatives and analgesics which can provide rapid onset, sufficient sedation and analgesia, a short recovery time and less adverse effects are the premise of performing painless gastroscopy. Currently, combined intravenous anesthesia with fentanyl and propofol, commonly used in the clinic, is still associated with a long duration of action, hypotension in some patients and prolonged recovery. Etomidate has been increasingly utilized for in-clinic diagnosis and treatment for procedures such as painless coloscopy and early induced abortion due to its rapid onset, rapid metabolism and minimal impact on the circulatory and respiratory systems. However, no study on combined intravenous anesthesia with fentanyl and etomidate for painless gastroscopy had previously been reported. The main purpose of this study is to explore the efficacy and safety of combined intravenous anesthesia with fentanyl and etomidate for painless gastroscopy compared with the combination of fentanyl and propofol in middle aged and elderly patients, and to provide reliable evidence for the implementation and promotion of comfortable medical care.
There are 6 centers for this trial: General Hospital of Chinese People's Liberation Army, Chaoyang Hospital Attached to the Capital Medical University, The Second Affiliated Hospital of Harbin Medical University, Renmin Hospital of Wuhan University Hubei General Hospital, The Affiliated Hospital of Xuzhou Medical College, Hospital of Chinese Air Force.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fentanyl & Propofol | Active Comparator | 0.02 ml/kg(1 μg/kg) fentanyl is diluted to 10 ml with normal saline and infused within 1 min, 4 min advance. 0.5 mg/kg(0.025 ml/kg) propofol is infused within 15 to 20 s. And then, depending on the randomized result, 0.5 mg/kg is given every time until the patient falls asleep. During the operation, 0.5 mg/kg is given when it is needed. |
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| fentanyl, propofol & etomidate | Experimental | 0.02 ml/kg(1 μg/kg) fentanyl is diluted to 10 ml with normal saline and infused within 1 min, 4 min advance. 0.5 mg/kg(0.025 ml/kg) propofol is infused within 15 to 20 s. And then, depending on the randomized result, 0.5 mg/kg etomidate is given every time until the patient falls asleep. During the operation, 0.5 mg/kg etomidate is given when it is needed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl Injection | Drug |
| ||
| Etomidate Fat Emulsion Injection |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | Changes of blood pressure in each group will be recorded. | baseline to 10 min after the operation, an expected average of 20 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate | Changes of heart rate in each group will be recorded. | baseline to the end of the operation, an expected average of 30 minutes |
| Pulse Oxygen Saturation | Changes of pulse oxygen saturation in each group will be recorded. |
| Measure | Description | Time Frame |
|---|---|---|
| efficacy of anesthesia | The time when propofol is given is defined as the time when infusion of propofol is beginning. The time of discharge is defined as the time when Steward score of the patient ≥4. | From the time when propofol is given to discharge, an expected average of 30 minutes |
| Satisfaction |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weidong Mi, Senior | Contact | +86-13381082966 | wwdd1962@yahoo.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Weidong Mi, Senior | General Hospital of Chinese People's Liberation Army | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chaoyang Hospital Attached to the Capital Medical University | Not yet recruiting | Beijing | Beijing Municipality | 100020 | China |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010636 | Phenols |
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| Drug |
|
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| Propofol Injection | Drug |
|
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| baseline to the end of the operation, an expected average of 10 minutes |
| Respiratory rate | Changes of respiratory rate in each group will be recorded | baseline to the end of the operation, an expected average of 10 minutes |
Record the satisfaction from the operator, the anesthetist and the patients |
| 10 minutes after the operation |
| Recovery of anesthesia | Steward score was used to evaluate the recovery of anesthesia. | 10 min, 15 min and 15 min after the operation |
| Recovery of orientation | MMSE scale is used to evaluate the recovery of orientation for each patient. | 10 min, 15 min and 20 min after the operation |
| Comfort degree | 10 minutes after the operation |
| Adverse events | during the operation, an expected average of 10 minutes |
| General Hospital of Chinese Air Force | Not yet recruiting | Beijing | Beijing Municipality | 100036 | China |
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| General Hospital of Chinese People's Liberation Army | Completed | Beijing | Beijing Municipality | 100853 | China |
| The Second Affiliated Hospital of Harbin Medical University | Recruiting | Harbin | Heilongjiang | 150086 | China |
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| Renmin Hospital of Wuhan University Hubei General Hospital | Recruiting | Wuhan | Hubei | China |
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| The Affiliated Hospital of Xuzhou Medical College | Not yet recruiting | Xuzhou | Jiangsu | 221006 | China |
|
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |