Combined Use of Etomidate and Propofol in Painless Gastroscopy.
NCT ID: NCT01913054
Last Updated: 2013-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
2450 participants
INTERVENTIONAL
2013-08-31
2013-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
DOUBLE
Study Groups
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Fentanyl & Propofol
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.
Fentanyl Injection
Propofol Injection
fentanyl, propofol & etomidate
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.
Fentanyl Injection
Etomidate Fat Emulsion Injection
Propofol Injection
Interventions
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Fentanyl Injection
Etomidate Fat Emulsion Injection
Propofol Injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age:between 45 to 75 years old (middle-aged group: 45\~59 years old; elderly group: 60\~75 years old; the percentage of middle-aged group and elderly group are 60% and 40%, respectively);
* BMI: between 18 to 25 kg/m2;
* ASA classification: grade Ⅰ\~Ⅱ.
Exclusion Criteria
* ECG before operation: \<50 beats per min;
* HGB before operation: \<90 g/L;
* Infected with respiratory inflammation and not cured within 2 weeks;
* Sever heart, brain, pulmonary, heptic, renal diseases or diabetes;
* History of difficult airway or abnormal recovery from anesthesia before or difficult airway is predicted to occur ;
* Obvious electrolyte disturbance such as hyperkalemia;
* Treated with immunosuppressants such as hormones for a long time or prior inhibition of the adrenal cortex;
* Allergic to emulsion or opioids;
* Concomitant other sedatives or analgesics (including injectable or oral administration of treatment related to Chinese Traditional Patent Medicines);
* Suspected abuse of narcotic analgesics or sedatives;
* Patients for whom it is difficult to cooperate or communicate because of abnormalities of neuromuscular system or mental disorder.
45 Years
75 Years
ALL
No
Sponsors
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Jiangsu Nhwa Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Weidong Mi, Senior
Role: PRINCIPAL_INVESTIGATOR
General Hospital of Chinese People's Liberation Army
Locations
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Chaoyang Hospital Attached to the Capital Medical University
Beijing, Beijing Municipality, China
General Hospital of Chinese Air Force
Beijing, Beijing Municipality, China
General Hospital of Chinese People's Liberation Army
Beijing, Beijing Municipality, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Renmin Hospital of Wuhan University Hubei General Hospital
Wuhan, Hubei, China
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Anshi Wu
Role: primary
Xiaodong Xue
Role: primary
Jinfeng Liu
Role: primary
Xingpeng Xiao
Role: primary
Lei Chen
Role: primary
Other Identifiers
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2013072201
Identifier Type: -
Identifier Source: org_study_id