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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Enrollment
2,450
Chaoyang Hospital Attached to the Capital Medical University
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGGeneral Hospital of Chinese Air Force
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGGeneral Hospital of Chinese People's Liberation Army
Beijing, Beijing Municipality, China
COMPLETEDThe Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
RECRUITINGRenmin Hospital of Wuhan University Hubei General Hospital
Wuhan, Hubei, China
RECRUITINGThe Affiliated Hospital of Xuzhou Medical College
Xuzhou, Jiangsu, China
NOT_YET_RECRUITINGBlood pressure
Changes of blood pressure in each group will be recorded.
Time frame: baseline to 10 min after the operation, an expected average of 20 minutes
Heart rate
Changes of heart rate in each group will be recorded.
Time frame: 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.
Time frame: 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
Time frame: baseline to the end of the operation, an expected average of 10 minutes
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