GastroscopyPhase 3NCT06858852

A Clinical Trial to Evaluate the Efficacy and Safety of Methoxyethyl Etomidate Hydrochloride for Sedation/Anesthesia During Gastroscopy/Colonoscopy

A Phase 3 study testing ET-26HCl 0.8mg/kg group and Etomidate Injectable Product 0.3mg/kg group in people with Gastroscopy and Colonoscopy, run by Ahon Pharmaceutical Co., Ltd. at 6 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Gastroscopy, Colonoscopy
What is being tested?: ET-26HCl 0.8mg/kg group and Etomidate Injectable Product 0.3mg/kg group
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 270 participants
Where: 6 sitesChina
Study dates: Mar 2025to Dec 2025
Phase: Phase 3
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

patients undergoing routine gastroscopy/colonoscopy;
age ≥ 18 and ≤ 75 years old, regardless of gender;
American Society of Anesthesiologists (ASA) grade I-III;
Body mass index (BMI) 18-30 kg/m2 (including the cut-off value) and body weight ≤100 kg;
Serum cortisol concentrations were either normal or abnormal but not clinically significant as judged by the investigator
Vital signs during screening:
respiratory rate ≥10 and ≤24 times/min; Pulse oxygen saturation (SpO2) ≥95% while breathing air; Systolic blood pressure (SBP) ≥90mmHg and ≤160mmHg; Diastolic blood pressure (DBP) ≥60mmHg and ≤100mmHg; Heart rate (ECG) ≥55 and ≤100 beats/min;
Able to understand the procedures and methods of this study, willing to sign the informed consent and strictly abide by the trial protocol to complete the study.

Who cannot join

patients with possible gastroduodenal outflow obstruction with retention of contents or upper gastrointestinal bleeding;
patients who were known or suspected to have allergies or contraindications to the components of the investigational drug or the prescribed regimen, or who were suspected to have epilepsy or severe liver and kidney dysfunction;
Predicted difficulty in intubation or ventilation (modified Markov score level III, level IV);
having any of the following respiratory management risks before/at the time of screening: 1) history of asthma, wheezing; 2) sleep apnea syndrome;
QTcF≥450 ms (male) or ≥470 ms (female) at screening and confirmed by review; Or clinically significant electrocardiographic abnormalities that were deemed by the investigator to be ineligible for the study;
use of any of the following drugs or treatments before screening:1) enrolled in a clinical trial of any drug within 1 month before screening; 2) use of medications or treatments that affect cortical function within 3 days before screening; 3) Use of medications that may affect QT interval within 2 weeks before screening;

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During the screening period, the laboratory examination indicators exceeded the abnormal level and had clinical significance, and were not suitable for enrollment after evaluation by the investigators;
pregnant and lactating women; The reluctance of women or men of childbearing potential to use contraception for the entire dosing period; Subjects (including male subjects) who plan to become pregnant within 3 months after the trial;
Subjects with any other factors considered by the investigator to be ineligible for participation in the trial.

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Xiaoran Yang contact

13146214840

yangxiaoran@avancpharma.com

City, postcode or hospital

6 sites in 1 country

China6 sites

Peking University First Hospital
Beijing, Beijing Municipality, 100034
Dongxin Wang
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Jin Liu
Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
Mengchang Yang
Guangyuan First People's Hospital
Guangyuan, Sichuan, 628017
Peng Li
Shenzhen People's Hospital
Shenzhen, Guangdong, 518020
Chaoran Wu
Yibin Second People's Hospital
Yibin, Sichuan, 644000
Jinghua Ren

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-blind, Etomidate Parallel Controlled Phase III Clinical Trial Was Conducted to Evaluate the Efficacy and Safety of Methoxyethyl Etomidate Hydrochloride for Sedation/Anesthesia During Gastroscopy/Colonoscopy

A total of 270 subjects undergoing gastroscopy/colonoscopy were randomly assigned to the methoxetomidate hydrochloride group and the etomidate group according to the ratio of 2:1 with etomidate as the control group.Neither the investigators nor the subjects were aware of the group assignments. Screening assessments for all subjects will be completed within D-14 to D-2 before the first dose. For all subjects who received the investigational drug, they were required to return to the research center on D2-5 to complete the corresponding examination before being discharged from the group. Compared with etomidate, the efficacy and safety of Methoxyethyl Etomidate Hydrochloride for sedation/anesthesia in gastroscopy/colonoscopy were further evaluated.

Conditions: Gastroscopy, Colonoscopy
Being tested: ET-26HCl 0.8mg/kg group, Etomidate Injectable Product 0.3mg/kg group

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ET-26HCl 0.8mg/kg groupDrug
The initial dose was 0.8 mg/kg administered as a single IV infusion over a period of 1 minute ±5 seconds. If needed, up to 50% of the starting dose was increased (30-seconds ± 5-seconds bolus)
Etomidate Injectable Product 0.3mg/kg groupDrug
The initial dose was 0.3 mg/kg administered as a single IV infusion over a period of 1 minute ±5 seconds. If needed, up to 50% of the starting dose was increased (30-seconds ± 5-seconds bolus)

Study groups in NCT06858852
Study group	Role	What they receive
ET-26 0.8mg group	Experimental	Experimental Receives: Drug: ET-26HCl 0.8mg/kg group
Etomidate group	Active comparator	Active Comparator Receives: Drug: Etomidate Injectable Product 0.3mg/kg group

What is being measured

The primary outcome is the main question the study is designed to answer.

Success rate of gastroscopy/colonoscopy
From the time of bolus administration to the completion of gastroscopy/colonoscopy, the following two conditions were met simultaneously: (1) the number of additional doses within any 15 minutes was ≤5; (2) no use of rescue drugs.
Measured: Within approximately 1 hour after injection

Secondary outcomes (10)

Sedation/anesthesia success rate
Percentage of subjects with a MOAA/S score ≤1 after initial dosing of the investigational drug
Measured: Within approximately 1 minute of the end of the injection
Duration of successful sedation/anesthesia
The time from the first administration of the experimental drug to the MOAA/S score ≤1
Measured: within approximately 1minute after injection
Duration from successful insertion to full consciousness
the time from successful insertion to full awakening (the first time of three consecutive MOAA/S scores reaching 5 points
Measured: after approximately 30 minutes of the completion of the last injection
Duration from completion of experimental drug administration to full recovery
The time between the completion of the last trial drug administration and the subject's full recovery (the first of three consecutive MOAA/S scores of 5
Measured: Within approximately 50 minutes of the completion of the last injection
The time from the end of treatment to full consciousness
The time from gastroscopy/colonoscopy withdrawal until the subject is fully awake (the first of three consecutive MOAA/S scores of 5
Measured: Within approximately 60 minutes of the completion of the first injection
The time from the end of the endoscopic session to discharge from the room
The first occurrence time from gastroscopy/colonoscopy withdrawal to 3 consecutive departures with Aldrete score ≥9
Measured: A maximum of 10 minutes after awakening
Rate of use of remedial drugs
Percentage of subjects who had used the sedative/anesthetic remedy propofol injection once or more
Measured: 60minutes after injection
Test drug additions
the additional situation and dosage of drugs were summarized
Measured: 30minutes after injection
Assessment of orientation
Orientation was evaluated when MOAA/S reached 5 points for the first time after the complete withdrawal of gastroscopy/colonoscopy
Measured: 20 minutes after the end of endoscopic treatment
Anesthesiologists' satisfaction with the recovery state of the subjects was evaluated
The total score is 10, that is, a score of 0 indicates very dissatisfied and a score of 10 indicates very satisfied
Measured: 60 minutes after the end of endoscopic treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2025Dec 2025

First posted5 Mar 2025
Study startMar 2025 (estimated)
Primary completionDec 2025 (estimated)
Study completionDec 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 270 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06858852
Sponsor's protocol ID: ET-26-HCl-302
Status last verified: Feb 2025
First submitted: 28 Feb 2025
Last updated: 5 Mar 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

Xiaoran Yang

13146214840

yangxiaoran@avancpharma.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Efficacy and Safety of OsrhCT Before Upper Endoscopy on Improving Visualization of the Gastric Mucosa.
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Application of Remimazolam Combined With Esketamine in Painless Gastroscopy and Colonoscopy in Elderly Patients
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The Impact of Long-term High-risk Drinking on the Effective Dose of Osselidin
Sedation
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Effect of Prolonged Fasting Time on Gastric Residual Volume in Patients Taking GLP1 Receptor Agonists
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ENDoscopic Assessment in Acute PANcreatitis Study (ENDOPAN Study)
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All Gastroscopy trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-blind, Etomidate Parallel Controlled Phase III Clinical Trial Was Conducted to Evaluate the Efficacy and Safety of Methoxyethyl Etomidate Hydrochloride for Sedation/Anesthesia During Gastroscopy/Colonoscopy
ClinicalTrials.gov ID: NCT06858852
Acronym / sponsor ID: ET-26-HCl-302
Conditions: Gastroscopy, Colonoscopy
Phase: Phase 3
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 270 participants (estimated)
Lead sponsor: Ahon Pharmaceutical Co., Ltd.University, hospital or other
Study start: Mar 2025 (estimated)
Primary completion: Dec 2025 (estimated)
Study completion: Dec 2025 (estimated)
First posted: 5 Mar 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
ET-26 0.8mg group	Experimental	Drug: ET-26HCl 0.8mg/kg groupExperimental
Etomidate group	Active comparator	Drug: Etomidate Injectable Product 0.3mg/kg groupActive Comparator

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

patients undergoing routine gastroscopy/colonoscopy;
age ≥ 18 and ≤ 75 years old, regardless of gender;
American Society of Anesthesiologists (ASA) grade I-III;
Body mass index (BMI) 18-30 kg/m2 (including the cut-off value) and body weight ≤100 kg;
Serum cortisol concentrations were either normal or abnormal but not clinically significant as judged by the investigator

Key exclusion criteria (9 listed)

patients with possible gastroduodenal outflow obstruction with retention of contents or upper gastrointestinal bleeding;
patients who were known or suspected to have allergies or contraindications to the components of the investigational drug or the prescribed regimen, or who were suspected to have epilepsy or severe liver and kidney dysfunction;
Predicted difficulty in intubation or ventilation (modified Markov score level III, level IV);
having any of the following respiratory management risks before/at the time of screening: 1) history of asthma, wheezing; 2) sleep apnea syndrome;
QTcF≥450 ms (male) or ≥470 ms (female) at screening and confirmed by review; Or clinically significant electrocardiographic abnormalities that were deemed by the investigator to be ineligible for the study;

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
ET-26HCl 0.8mg/kg groupThe initial dose was 0.8 mg/kg administered as a single IV infusion over a period of 1 minute ±5 seconds. If needed, up to 50% of the starting dose was increased (30-seconds ± 5-seconds bolus)	Drug	ET-26 0.8mg group
Etomidate Injectable Product 0.3mg/kg groupThe initial dose was 0.3 mg/kg administered as a single IV infusion over a period of 1 minute ±5 seconds. If needed, up to 50% of the starting dose was increased (30-seconds ± 5-seconds bolus)	Drug	Etomidate group

Primary outcome

Success rate of gastroscopy/colonoscopy
Time frame: Within approximately 1 hour after injection
From the time of bolus administration to the completion of gastroscopy/colonoscopy, the following two conditions were met simultaneously: (1) the number of additional doses within any 15 minutes was ≤5; (2) no use of rescue drugs.

10 secondary outcomes

Sedation/anesthesia success rate
Time frame: Within approximately 1 minute of the end of the injection
Duration of successful sedation/anesthesia
Time frame: within approximately 1minute after injection
Duration from successful insertion to full consciousness
Time frame: after approximately 30 minutes of the completion of the last injection
Duration from completion of experimental drug administration to full recovery
Time frame: Within approximately 50 minutes of the completion of the last injection
The time from the end of treatment to full consciousness
Time frame: Within approximately 60 minutes of the completion of the first injection
The time from the end of the endoscopic session to discharge from the room
Time frame: A maximum of 10 minutes after awakening
Rate of use of remedial drugs
Time frame: 60minutes after injection
Test drug additions
Time frame: 30minutes after injection
Assessment of orientation
Time frame: 20 minutes after the end of endoscopic treatment
Anesthesiologists' satisfaction with the recovery state of the subjects was evaluated
Time frame: 60 minutes after the end of endoscopic treatment

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 5 Mar 2025.

Related trials for Gastroscopy

Not yet recruitingPhase 2
Efficacy and Safety of OsrhCT Before Upper Endoscopy on Improving Visualization of the Gastric Mucosa.
Gastric Mucosal Lesion
Active, not recruiting
Application of Remimazolam Combined With Esketamine in Painless Gastroscopy and Colonoscopy in Elderly Patients
Gastrointestinal Disease
Not yet recruiting
The Impact of Long-term High-risk Drinking on the Effective Dose of Osselidin
Sedation
Recruiting
Effect of Prolonged Fasting Time on Gastric Residual Volume in Patients Taking GLP1 Receptor Agonists
Upper Endoscopy, GLP1-R-related Disease
RecruitingObservational study
ENDoscopic Assessment in Acute PANcreatitis Study (ENDOPAN Study)
Acute Pancreatitis (AP)

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.

Xiaoran Yang contact

13146214840

yangxiaoran@avancpharma.com

Mengchang Yang principal investigator

Sichuan Academy of Medical Sciences

Jin Liu principal investigator

West China Hospital

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ET-26HCl 0.8mg/kg group and Etomidate Injectable Product 0.3mg/kg group in people with Gastroscopy and Colonoscopy, run by Ahon 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 8 inclusion and 9 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 5 Mar 2025. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Xiaoran Yang (13146214840, yangxiaoran@avancpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Success rate of gastroscopy/colonoscopy (time frame: Within approximately 1 hour after injection). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06858852.

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 5 Mar 2025.