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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 rate

Pulse 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

Page last updated: August 20, 2015

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