Safety of GastroscopyPhase 4NCT01913054
Combined Use of Etomidate and Propofol in Painless Gastroscopy.
A Phase 4 study testing Fentanyl Injection, Etomidate Fat Emulsion Injection and Propofol Injection in people with Safety of Gastroscopy, run by Jiangsu Nhwa Pharmaceutical Co., Ltd. at 6 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Safety of Gastroscopy
- What is being tested?
- Fentanyl Injection, Etomidate Fat Emulsion Injection and Propofol Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,450 participants
- Where
- 6 sitesChina
- Study dates
- Aug 2013to Dec 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 ;
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- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites, 5 recruiting
- Not yet recruiting
Chaoyang Hospital Attached to the Capital Medical University
Beijing, Beijing Municipality, 100020
Anshi Wu, 13511010883
Anshi Wu
- Not yet recruiting
General Hospital of Chinese Air Force
Beijing, Beijing Municipality, 100036
Xiaodong Xue, 13311161680
Xiaodong Xue
- Completed
General Hospital of Chinese People's Liberation Army
Beijing, Beijing Municipality, 100853
- Recruiting
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150086
Jinfeng Liu, 15663488219, 13936322563@126.com
Jinfeng Liu
- Recruiting
Renmin Hospital of Wuhan University Hubei General Hospital
Wuhan, Hubei
Xingpeng Xiao, 18971227731
Xingpeng Xiao
- Not yet recruiting
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, Jiangsu, 221006
Lei Chen, 13905202758
Lei Chen
About this study
Official title: Combined Use of Etomidate and Propofol in Painless Gastroscopy, a Multiple Center, Double Blinded, Randomized,Controled Study.
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.
Read the 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.
- Conditions
- Safety of Gastroscopy
- Being tested
- Fentanyl Injection, Etomidate Fat Emulsion Injection, Propofol Injection
- Keywords
- Etomidate, Propofol, Painless gastroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl InjectionDrug
Etomidate Fat Emulsion InjectionDrug
Also called Fuerli
Propofol InjectionDrug
Also called Jing'an
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Fentanyl Injection; Drug: Propofol Injection |
| 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. Receives: Drug: Fentanyl Injection; Drug: Etomidate Fat Emulsion Injection; Drug: Propofol Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Changes of blood pressure in each group will be recorded.
Measured: baseline to 10 min after the operation, an expected average of 20 minutes
Secondary outcomes (3)
Heart rate
Changes of heart rate in each group will be recorded.
Measured: 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.
Measured: 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
Measured: baseline to the end of the operation, an expected average of 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety of GastroscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2,450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Nhwa Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Weidong Mi, Senior, Principal investigator, General Hospital of Chinese People's Liberation Army
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01913054
- Sponsor's protocol ID
- 2013072201
- Status last verified
- Jul 2013
- First submitted
- 25 Jul 2013
- Last updated
- 16 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Use of Etomidate and Propofol in Painless Gastroscopy, a Multiple Center, Double Blinded, Randomized,Controled Study.
- ClinicalTrials.gov ID
- NCT01913054
- Acronym / sponsor ID
- 2013072201
- Conditions
- Safety of Gastroscopy
- Keywords
- Etomidate, Propofol, Painless gastroscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,450 participants (estimated)
- Lead sponsor
- Jiangsu Nhwa Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 31 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fentanyl & Propofol | Active comparator | Drug: Fentanyl Injection, Drug: Propofol Injection0.02 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, propofol & etomidate | Experimental | Drug: Fentanyl Injection, Drug: Etomidate Fat Emulsion Injection, Drug: Propofol Injection0.02 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. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fentanyl Injection | Drug | Fentanyl & Propofol, fentanyl, propofol & etomidate |
| Etomidate Fat Emulsion InjectionAlso: Fuerli | Drug | fentanyl, propofol & etomidate |
| Propofol InjectionAlso: Jing'an | Drug | Fentanyl & Propofol, fentanyl, propofol & etomidate |
Primary outcome
Blood pressure
Time frame: baseline to 10 min after the operation, an expected average of 20 minutes
Changes of blood pressure in each group will be recorded.
3 secondary outcomes
Heart rate
Time frame: baseline to the end of the operation, an expected average of 30 minutes
Pulse Oxygen Saturation
Time frame: baseline to the end of the operation, an expected average of 10 minutes
Respiratory rate
Time frame: baseline to the end of the operation, an expected average of 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2013.
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Evaluation of the Efficacy and Safety of Magnetically-controlled Capsule Gastroscopy for Postoperative Assessment in Elderly Patients and Patients With Underlying Diseases
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weidong Mi, Senior principal investigator
General Hospital of Chinese People's Liberation Army
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fentanyl Injection, Etomidate Fat Emulsion Injection and Propofol Injection in people with Safety of Gastroscopy, run by Jiangsu Nhwa Pharmaceutical Co., Ltd. at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weidong Mi, Senior (+86-13381082966, wwdd1962@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: baseline to 10 min after the operation, an expected average of 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2013.