Combined Use of Etomidate and Propofol in Painless Gastroscopy.
Information source: Jiangsu Nhwa Pharmaceutical Co.,LTD
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Safety of Gastroscopy
Intervention: Fentanyl Injection (Drug); Etomidate Fat Emulsion Injection (Drug); Propofol Injection (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Jiangsu Nhwa Pharmaceutical Co.,LTD Official(s) and/or principal investigator(s): Weidong Mi, Senior, Principal Investigator, Affiliation: General Hospital of Chinese People's Liberation Army
Overall contact: Weidong Mi, Senior, Phone: +86-13381082966, Email: wwdd1962@yahoo.com.cn
Summary
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.
Clinical Details
Official title: Combined Use of Etomidate and Propofol in Painless Gastroscopy, a Multiple Center, Double Blinded, Randomized,Controled Study.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic
Primary outcome: Blood pressure
Secondary outcome: Heart ratePulse Oxygen Saturation Respiratory rate
Detailed description:
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.
Eligibility
Minimum age: 45 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Preparing to take gastroscopy;
- 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:
- Blood pressure before operation: >180 mm Hg or <90 mm Hg;
- 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.
Locations and Contacts
Weidong Mi, Senior, Phone: +86-13381082966, Email: wwdd1962@yahoo.com.cn
Chaoyang Hospital Attached to the Capital Medical University, Peking, Beijing 100020, China; Not yet recruiting Anshi Wu, Phone: 13511010883 Anshi Wu, Principal Investigator
General Hospital of Chinese Air Force, Peking, Beijing 100036, China; Not yet recruiting Xiaodong Xue, Phone: 13311161680 Xiaodong Xue, Principal Investigator
General Hospital of Chinese People's Liberation Army, Peking, Beijing 100853, China; Completed
The Second Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang 150086, China; Recruiting Jinfeng Liu, Phone: 15663488219, Email: 13936322563@126.com Jinfeng Liu, Principal Investigator
Renmin Hospital of Wuhan University Hubei General Hospital, Wuhan, Hubei, China; Recruiting Xingpeng Xiao, Phone: 18971227731 Xingpeng Xiao, Principal Investigator
The Affiliated Hospital of Xuzhou Medical College, Xuzhou, Jiangsu 221006, China; Not yet recruiting Lei Chen, Phone: 13905202758 Lei Chen, Principal Investigator
Additional Information
Starting date: August 2013
Last updated: December 13, 2013
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