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

February 28, 2025 updated by: Ahon Pharmaceutical Co., Ltd.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
270

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

  6. 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;

  7. 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.

Exclusion Criteria:

  1. patients with possible gastroduodenal outflow obstruction with retention of contents or upper gastrointestinal bleeding;
  2. 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;
  3. Predicted difficulty in intubation or ventilation (modified Markov score level III, level IV);
  4. having any of the following respiratory management risks before/at the time of screening: 1) history of asthma, wheezing; 2) sleep apnea syndrome;
  5. 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;
  6. 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;
  7. 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;
  8. 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;
  9. Subjects with any other factors considered by the investigator to be ineligible for participation in the trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ET-26 0.8mg group
Experimental
Drug: ET-26HCl 0.8mg/kg group
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)
Active Comparator: Etomidate group
Active Comparator
Drug: Etomidate Injectable Product 0.3mg/kg group
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Within approximately 1 hour after injection

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sedation/anesthesia success rate
Time Frame: Within approximately 1 minute of the end of the injection
Percentage of subjects with a MOAA/S score ≤1 after initial dosing of the investigational drug
Within approximately 1 minute of the end of the injection
Duration of successful sedation/anesthesia
Time Frame: within approximately 1minute after injection
The time from the first administration of the experimental drug to the MOAA/S score ≤1
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
the time from successful insertion to full awakening (the first time of three consecutive MOAA/S scores reaching 5 points
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 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
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 gastroscopy/colonoscopy withdrawal until the subject is fully awake (the first of three consecutive MOAA/S scores of 5
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
The first occurrence time from gastroscopy/colonoscopy withdrawal to 3 consecutive departures with Aldrete score ≥9
A maximum of 10 minutes after awakening
Rate of use of remedial drugs
Time Frame: 60minutes after injection
Percentage of subjects who had used the sedative/anesthetic remedy propofol injection once or more
60minutes after injection
Test drug additions
Time Frame: 30minutes after injection
the additional situation and dosage of drugs were summarized
30minutes after injection
Assessment of orientation
Time Frame: 20 minutes after the end of endoscopic treatment
Orientation was evaluated when MOAA/S reached 5 points for the first time after the complete withdrawal of gastroscopy/colonoscopy
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
The total score is 10, that is, a score of 0 indicates very dissatisfied and a score of 10 indicates very satisfied
60 minutes after the end of endoscopic treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ahon Pharmaceutical Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mengchang Yang, Sichuan Academy of Medical Sciences
  • Principal Investigator: Jin Liu, West China Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ET-26-HCl-302

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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