Gastrointestinal EndoscopyNCT07079176
Etomidate Combined With Propofol Versus Propofol for Sedation in High-Altitude Patients During Gastroscopy: a Randomized Multicenter Clinical Trial
A study testing etomidate combined with propofol and propofol in people with Gastrointestinal Endoscopy, run by RenJi Hospital.
Trial summary
One of the most common adverse events during sedated gastrointestinal endoscopy is hypoxemia, which can lead to serious consequences. When sedated gastrointestinal endoscopy is performed in high-altitude regions with thin air and lower atmospheric pressure, the risk of hypoxemia in patients significantly increases. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastrointestinal Endoscopy
- What is being tested?
- etomidate combined with propofol and propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 732 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 ≤ years ≤ 70 Patients undergoing pain-free gastroscopy or treatment Endoscopy duration within 30 minutes Informed consent obtained from patient or family member
Who cannot join
- Concomitant diagnosis of cardiac diseases (e.g., heart failure, angina, myocardial infarction, arrhythmia) Diagnosed pulmonary diseases Liver diseases Kidney diseases Intracranial hypertension ASA class III or higher Concomitant active upper respiratory tract infection
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
One of the most common adverse events during sedated gastrointestinal endoscopy is hypoxemia, which can lead to serious consequences. When sedated gastrointestinal endoscopy is performed in high-altitude regions with thin air and lower atmospheric pressure, the risk of hypoxemia in patients significantly increases. Traditionally, propofol is the primary agent for sedation during gastrointestinal endoscopy, offering rapid onset and recovery. However, propofol has many side effects, the most important of which is inhibition of respiration and hypotension. Etomidate has less effect on respiration compared to propofol. But there are also adverse reactions of etomidate such as muscular tremor, nausea and vomiting. This study aims to explore whether the etomidate combined with propofol anesthesia method can reduce the risk of hypoxemia during sedated gastrointestinal endoscopy in high-altitude regions, compared to the traditional propofol anesthesia method .
- Conditions
- Gastrointestinal Endoscopy
- Being tested
- etomidate combined with propofol, propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etomidate combined with propofolDrug
Patients initially received oxygen via nasal cannula at 5 L/min. All patients underwent routine noninvasive monitoring of blood pressure, ECG, and oxygen saturation. In the EP group, patients received 50 μg fentanyl, followed by a slow intravenous injection of a propofol-etomidate mixture (10 mL:20 mg etomidate + 10 mL:100 mg propofol) at 0.1-0.2 mL/kg. Supplemental doses of 0.05 mL/kg were administered as needed to maintain sedation throughout the procedure.
propofolDrug
Patients initially received oxygen via nasal cannula at 5 L/min. All underwent routine noninvasive monitoring of blood pressure, ECG, and oxygen saturation. In the P group, 50 μg fentanyl was administered, followed by a slow intravenous injection of propofol (1-2 mg/kg) after 3 minutes. Supplemental doses of 0.5 mg/kg were administered as needed to maintain sedation throughout the procedure.
| Study group | Role | What they receive |
|---|---|---|
| EP group | Experimental | Not described Receives: Drug: etomidate combined with propofol |
| P group | Active comparator | Not described Receives: Drug: propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The risk of hypoxemia
Measured: during sedated gastrointestinal endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal EndoscopyStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 732 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07079176
- Sponsor's protocol ID
- 2025-6-20
- Status last verified
- Jul 2025
- First submitted
- 13 Jul 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etomidate Combined With Propofol Versus Propofol for Sedation in High-Altitude Patients During Gastroscopy: a Randomized Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT07079176
- Acronym / sponsor ID
- 2025-6-20
- Conditions
- Gastrointestinal Endoscopy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 732 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 22 Jul 2025 (actual)
- 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.
One of the most common adverse events during sedated gastrointestinal endoscopy is hypoxemia, which can lead to serious consequences. When sedated gastrointestinal endoscopy is performed in high-altitude regions with thin air and lower atmospheric pressure, the risk of hypoxemia in patients significantly increases. Traditionally, propofol is the primary agent for sedation during gastrointestinal endoscopy, offering rapid onset and recovery. However, propofol has many side effects, the most important of which is inhibition of respiration and hypotension. Etomidate has less effect on respiration compared to propofol. But there are also adverse reactions of etomidate such as muscular tremor, nausea and vomiting. This study aims to explore whether the etomidate combined with propofol anesthesia method can reduce the risk of hypoxemia during sedated gastrointestinal endoscopy in high-altitude regions, compared to the traditional propofol anesthesia method .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EP group | Experimental | Drug: etomidate combined with propofol |
| P group | Active comparator | Drug: propofol |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age: 18 ≤ years ≤ 70 Patients undergoing pain-free gastroscopy or treatment Endoscopy duration within 30 minutes Informed consent obtained from patient or family member
Key exclusion criteria (1 listed)
- Concomitant diagnosis of cardiac diseases (e.g., heart failure, angina, myocardial infarction, arrhythmia) Diagnosed pulmonary diseases Liver diseases Kidney diseases Intracranial hypertension ASA class III or higher Concomitant active upper respiratory tract infection
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 combined with propofolPatients initially received oxygen via nasal cannula at 5 L/min. All patients underwent routine noninvasive monitoring of blood pressure, ECG, and oxygen saturation. In the EP group, patients received 50 μg fentanyl, followed by a slow intravenous injection of a propofol-etomidate mixture (10 mL:20 mg etomidate + 10 mL:100 mg propofol) at 0.1-0.2 mL/kg. Supplemental doses of 0.05 mL/kg were administered as needed to maintain sedation throughout the procedure. | Drug | EP group |
| propofolPatients initially received oxygen via nasal cannula at 5 L/min. All underwent routine noninvasive monitoring of blood pressure, ECG, and oxygen saturation. In the P group, 50 μg fentanyl was administered, followed by a slow intravenous injection of propofol (1-2 mg/kg) after 3 minutes. Supplemental doses of 0.5 mg/kg were administered as needed to maintain sedation throughout the procedure. | Drug | P group |
Primary outcome
The risk of hypoxemia
Time frame: during sedated gastrointestinal endoscopy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing etomidate combined with propofol and propofol in people with Gastrointestinal Endoscopy, run by RenJi Hospital.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 22 Jul 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pan ZY (021-58752345, rshjsh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The risk of hypoxemia (time frame: during sedated gastrointestinal endoscopy). 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 22 Jul 2025.