Complication of GastrostomyNCT01729897
Etomidate Emulsion for Sedation in Patients Scheduled for Upper Gastrointestinal (GI) Endoscopy
A study testing Etomidate, Fentanyl and Propofol in people with Complication of Gastrostomy, run by Jiangsu Nhwa Pharmaceutical Co., Ltd..
Trial summary
The study is designed to explore and compare the efficacy and safety of etomidate and propofol with or without analgesic for painless gastroscopy, and to provide more reliant support for implementation and promotion of comfort care. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Complication of Gastrostomy
- What is being tested?
- Etomidate, Fentanyl and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 328 participants
- Where
- No sites listed yet
- Study dates
- May 2012to Oct 2012
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for painless gastroscopy
- 18-80 year old
- 18 H2 ≤ weight ≤ 35 H2 (H indicates height)
- American Society of Anesthesiologists (ASA) physical status class 1-3
- The duration of surgery is ≤ 60 min ( duration of surgery was defined as the interval time from insert to withdraw of catheter)
- Without liver, kidney and heart disease history
- No previous history of abnormal recovery of anesthesia in surgery
Who cannot join
- Patients whom do not wish to perform painless gastroscopy or participate in the study
- Patients with medical history of severe heart, lung, liver, kidney or metabolic disease
- Patients with abnormal ECG presented as heart rate 50 < beat/min
- Patients who suffered from acute inflammation of respiratory tract within the past 2 weeks and did not be cured of it before participating in the study
- Hypertension patient with preoperative blood pressure > 180/90 mmHg; hypotension patients with preoperative blood pressure < 90/60 mmHg;
- Patients with neuromuscular disease, mental disorders
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- Hemoglobin is less than 90 g/L
- Patients with suspected abuse of Anesthesia and Analgesia
- Patients who were predicted to have or had previous difficult airway ( difficult airway is defined as the clinical situation in which a conventionally trained anesthesiologist experiences three failures of intubation)
- Patients with known emulsion or opioid allergy
- Patients who will be noncompliant or unable to communicate
- Patients who received long-term treatment with hormone or had history of adrenocortical suppression
- Patients received coadministration of other sedative, analgesic ( including injection, oral or usage of relevant Chinese patent medicine) before, during or 15 min after the procedure
- Patients who appeared nausea and vomit, dizziness
- Patients with sever diabetes mellitus, hyperkaliemia or significant electrolyte disturbances
About this study
Official title: A Multicenter Open-label Randomized Controlled Clinical Trial of Etomidate Emulsion for Sedation in Patients Scheduled for Upper GI Endoscopy
The study is designed to explore and compare the efficacy and safety of etomidate and propofol with or without analgesic for painless gastroscopy, and to provide more reliant support for implementation and promotion of comfort care.
Read the detailed description
To widely implement painless gastroscopy is required by diagnose and treatment with gastroscopy due to the large number and significant suffering of the patients. Also, development and exploration of anesthesiology will be bound to prompt the development and exploration of painless gastroscopy. However, the anesthesia risk of painless gastroscopy are usually higher than that of general anesthesia performed in operating room due to the condition, monitoring and equipments as well as the staffing for its implementation. Thus, the finding of a safe and convenient approach for general anesthesia will have a profound impact on a full promotion and implementation of comfortable care.
Etomidate, with the main advantage of little effect on circulatory and respiratory systems, and the features of rapid onset and metabolism, may be helpful to guarantee the safety of painless diagnosis and treatment, thus appropriate for the procedure with short duration of anesthesia. However, there is controversy regarding whether analgesic should be used in combination, as well as how to given the combined regimen.
- Conditions
- Complication of Gastrostomy
- Keywords
- gastroscopy, sedation, etomidate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Etomidate & Fentanyl | Experimental | * 4 min before procedure: fentanyl 1 μg/kg (0.02 ml/kg), intravenous injection
* After injection of fentanyl, etomidate was infused intravenously at rate of 200 ml/h for 30 seconds with unified injection pump, then after interval time of 30 seconds, infusion rate was altered to 500 ml/h and infusion was sustained until patients fell asleep.
* Additional dose of etomidate would be administrated separately when duration of procedure was prolonged. Receives: Drug: Etomidate; Drug: Fentanyl |
| Propofol & Fentanyl | Placebo comparator | * 4 min before procedure: fentanyl 1 g/kg (0.02 ml/kg), intravenous injection
* After injection of fentanyl, propofol was infused intravenously at rate of 200 ml/h for 30 seconds with unified injection pump, then after interval time of 30 seconds, infusion rate was altered to 500 ml/h and infusion was sustained until patients fell asleep.
* Additional dose of propofol would be administrated separately when duration of procedure was prolonged. Receives: Drug: Fentanyl; Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
the minimum blood pressure
Measured: participants will be followed for the duration that from the beginning of the surgery to the extraction of the gastroscopy, an expected average of 2 hours
the proportion of hypotension
Measured: participants will be followed for the duration that from the beginning of the surgery to the extraction of the gastroscopy, an expected average of 2 hours
the minimum oxygen saturation of blood
Measured: participants will be followed for the duration that from the beginning of the surgery to the extraction of the gastroscopy, an expected average of 2 hours
Time interval
the time interval that from the last administration of etomidate to when the patient leave the hospital
Measured: from the last administration of etomidate to when the patient leave the hospital
Secondary outcomes (2)
Incidence rate of the side effects
the side effects include dizziness，nausea，vomit，myoclonia，injection pain，and the awareness during operation
Measured: participants will be followed for the duration from the beginning of the surgery to leaving hospital，an expected average of 4 hours
the cost of the experiment drug
Measured: the money that the participants spend from the beginning of the surgery to leaving hospital，an expected average of 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2012 (estimated)
- Study startMay 2012
- Primary completionAug 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication of GastrostomyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Nhwa Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01729897
- Sponsor's protocol ID
- ChiCTR-TRC-20121001
- Status last verified
- May 2013
- First submitted
- 18 Oct 2012
- Last updated
- 13 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Open-label Randomized Controlled Clinical Trial of Etomidate Emulsion for Sedation in Patients Scheduled for Upper GI Endoscopy
- ClinicalTrials.gov ID
- NCT01729897
- Acronym / sponsor ID
- ChiCTR-TRC-20121001
- Conditions
- Complication of Gastrostomy
- Keywords
- gastroscopy, sedation, etomidate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- Jiangsu Nhwa Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 20 Nov 2012 (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.
The study is designed to explore and compare the efficacy and safety of etomidate and propofol with or without analgesic for painless gastroscopy, and to provide more reliant support for implementation and promotion of comfort care.
Detailed description
To widely implement painless gastroscopy is required by diagnose and treatment with gastroscopy due to the large number and significant suffering of the patients. Also, development and exploration of anesthesiology will be bound to prompt the development and exploration of painless gastroscopy. However, the anesthesia risk of painless gastroscopy are usually higher than that of general anesthesia performed in operating room due to the condition, monitoring and equipments as well as the staffing for its implementation. Thus, the finding of a safe and convenient approach for general anesthesia will have a profound impact on a full promotion and implementation of comfortable care.
Etomidate, with the main advantage of little effect on circulatory and respiratory systems, and the features of rapid onset and metabolism, may be helpful to guarantee the safety of painless diagnosis and treatment, thus appropriate for the procedure with short duration of anesthesia. However, there is controversy regarding whether analgesic should be used in combination, as well as how to given the combined regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Etomidate & Fentanyl | Experimental | Drug: Etomidate, Drug: Fentanyl* 4 min before procedure: fentanyl 1 μg/kg (0.02 ml/kg), intravenous injection * After injection of fentanyl, etomidate was infused intravenously at rate of 200 ml/h for 30 seconds with unified injection pump, then after interval time of 30 seconds, infusion rate was altered to 500 ml/h and infusion was sustained until patients fell asleep. * Additional dose of etomidate would be administrated separately when duration of procedure was prolonged. |
| Propofol & Fentanyl | Placebo comparator | Drug: Fentanyl, Drug: Propofol* 4 min before procedure: fentanyl 1 g/kg (0.02 ml/kg), intravenous injection * After injection of fentanyl, propofol was infused intravenously at rate of 200 ml/h for 30 seconds with unified injection pump, then after interval time of 30 seconds, infusion rate was altered to 500 ml/h and infusion was sustained until patients fell asleep. * Additional dose of propofol would be administrated separately when duration of procedure was prolonged. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients scheduled for painless gastroscopy
- 18-80 year old
- 18 H2 ≤ weight ≤ 35 H2 (H indicates height)
- American Society of Anesthesiologists (ASA) physical status class 1-3
- The duration of surgery is ≤ 60 min ( duration of surgery was defined as the interval time from insert to withdraw of catheter)
Key exclusion criteria (15 listed)
- Patients whom do not wish to perform painless gastroscopy or participate in the study
- Patients with medical history of severe heart, lung, liver, kidney or metabolic disease
- Patients with abnormal ECG presented as heart rate 50 < beat/min
- Patients who suffered from acute inflammation of respiratory tract within the past 2 weeks and did not be cured of it before participating in the study
- Hypertension patient with preoperative blood pressure > 180/90 mmHg; hypotension patients with preoperative blood pressure < 90/60 mmHg;
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 |
|---|---|---|
| Etomidate | Drug | Etomidate & Fentanyl |
| Fentanyl | Drug | Etomidate & Fentanyl, Propofol & Fentanyl |
| Propofol | Drug | Propofol & Fentanyl |
Primary outcome
the minimum blood pressure
Time frame: participants will be followed for the duration that from the beginning of the surgery to the extraction of the gastroscopy, an expected average of 2 hours
the proportion of hypotension
Time frame: participants will be followed for the duration that from the beginning of the surgery to the extraction of the gastroscopy, an expected average of 2 hours
the minimum oxygen saturation of blood
Time frame: participants will be followed for the duration that from the beginning of the surgery to the extraction of the gastroscopy, an expected average of 2 hours
Time interval
Time frame: from the last administration of etomidate to when the patient leave the hospital
the time interval that from the last administration of etomidate to when the patient leave the hospital
2 secondary outcomes
Incidence rate of the side effects
Time frame: participants will be followed for the duration from the beginning of the surgery to leaving hospital，an expected average of 4 hours
the cost of the experiment drug
Time frame: the money that the participants spend from the beginning of the surgery to leaving hospital，an expected average of 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Etomidate, Fentanyl and Propofol in people with Complication of Gastrostomy, run by Jiangsu Nhwa Pharmaceutical Co., Ltd..
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 7 inclusion and 15 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: finished, as of the sponsor's last update on 13 May 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the minimum blood pressure (time frame: participants will be followed for the duration that from the beginning of the surgery to the extraction of the gastroscopy, an expected average of 2 hours). The study lists 4 primary outcomes in all. 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 13 May 2013.