Sedation ComplicationNCT05407870
Efficacy and Safety of Etomidate Sedation in Gastric Endoscopic Submucosal Dissection
A study testing Etomidate Injection and Propofol Injection in people with Sedation Complication and Endoscopic Submucosal Dissection, run by Korea University Anam Hospital at 1 site in South Korea.
Trial summary
During endoscopy, the patient is sedated to relieve pain and improve the ease of the procedure. Sedation endoscopy using propofol is effective, but has the disadvantage that cardiopulmonary side effects are frequently observed. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Sedation Complication, Endoscopic Submucosal Dissection, Esophagogastroduodenoscopy
- What is being tested?
- Etomidate Injection and Propofol Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Jun 2022to 24 Nov 2022
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 19-80
- American Society of Anesthesiologists Physical Status Classification System (ASA) score of I, II, III
- Scheduled endoscopy
Who cannot join
- Pregnancy
- Previous study History of hypersensitivity to drugs or substances containing soy or egg ingredients
- Those who think that tracheal intubation will be difficult
- Obstructive sleep apnea
- History of side effects from previous sedatives
- People with severe liver disease, kidney disease, or heart disease
Show all 10Show fewer
- Those who want a non-sleeping endoscope
- A person who refuses to provide consent
- SBP \< 80mmHg or SpO2 \< 90%
- Patients with adrenocortical dysfunction, chronic steroid users
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Korea University Anam Hospital
Seoul, Seoung-buk Gu, 02841
About this study
Official title: A Comparative Study of the Efficacy and Safety of Etomidate Compared to Propofol in Gastric Endoscopic Submucosal Dissection: a Prospective, Single-center, Randomized, Double-blind, Non-inferiority Study
During endoscopy, the patient is sedated to relieve pain and improve the ease of the procedure. Sedation endoscopy using propofol is effective, but has the disadvantage that cardiopulmonary side effects are frequently observed. However, etomidate is known to have hemodynamic and respiratory stability.The purpose of this study was to compare the efficacy and safety of etomidate and propofol in sedated gastric endoscopic submucosal dissection.
- Being tested
- Etomidate Injection, Propofol Injection
- Keywords
- Etomidate, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Etomidate InjectionDrug
Proofol and etomidate are drugs used for sedation and have the same white color.
Gastric endoscopic submucosal dissection is performed using propofol in the control group and etomidate in the experimental group.
Efficacy and safety of sedatives were confirmed using propofol and etomidate.
Propofol InjectionDrug
Proofol and etomidate are drugs used for sedation and have the same white color.
Gastric endoscopic submucosal dissection is performed using propofol in the control group and etomidate in the experimental group.
Efficacy and safety of sedatives were confirmed using propofol and etomidate.
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Active comparator | induction - 0.5mg/kg Propofol maintenance - 0.25mg/kg Propofol Receives: Drug: Propofol Injection |
| Etomidate | Experimental | induction - 0.25mg/kg Propofol + 0.05mg/kg Etomidate maintenance - 0.05mg/kg Etomidate Receives: Drug: Etomidate Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory adverse event
the number and proportion of cases of respiratory depression
Measured: during gastric endoscopic submucosal dissection
Secondary outcomes (6)
ESD clinical outcomes
tumor location, tumor pathology, ESD specimen size, En-bloc resection, submucosal invasion, margin positive
Measured: From enrollment to the first clinic visit (within 60 days)
Adverse events and procedure interruptions
Overall adverse events Cardiopulmonary adverse events Procedure-related adverse events
Overall procedure interruption procedure interruption due to cardiopulmonary adverse events procedure interruption due to procedure-related adverse events
Measured: during gastric endoscopic submucosal dissection
Sedation-related profile
administered dose of sedatives (induction dose, maintenance dose, total dose), induction time, awake time, sedation time
Measured: From initial administering the sedative drug to endoscopy room discharge (up to 2 hours); dose (ml)
Satisfaction assessment
patient satisfaction regarding sedation, doctor and nurse satisfaction regarding sedation during ESD
Measured: From initial administering the sedative drug to endoscopy room discharge; satisfaction score (0-10, 10 is the highest score)
Hemodynamic changes
systolic blood pressure, diastolic blood pressure, mean arterial blood pressure, heart rate, oxygen saturation
Measured: From date of randomization until the date of first documented progression (up to 2 hours)
Factors associated with adverse events
factor analysis regarding overall adverse events factor analysis regarding overall cardiopulmonary adverse events factor analysis regarding overall procedure adverse events
Measured: From date of randomization until the date of first documented progression (up to three days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start9 Jun 2022
- Primary completion24 Nov 2022
- Study completion24 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedation ComplicationStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keum, Bo Ra, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05407870
- Sponsor's protocol ID
- 2020AN0375
- Status last verified
- Sep 2024
- First submitted
- 2 Jun 2022
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of the Efficacy and Safety of Etomidate Compared to Propofol in Gastric Endoscopic Submucosal Dissection: a Prospective, Single-center, Randomized, Double-blind, Non-inferiority Study
- ClinicalTrials.gov ID
- NCT05407870
- Acronym / sponsor ID
- 2020AN0375
- Keywords
- Etomidate, Propofol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Study start
- 9 Jun 2022 (actual)
- Primary completion
- 24 Nov 2022 (actual)
- Study completion
- 24 Nov 2022 (actual)
- First posted
- 7 Jun 2022 (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.
During endoscopy, the patient is sedated to relieve pain and improve the ease of the procedure. Sedation endoscopy using propofol is effective, but has the disadvantage that cardiopulmonary side effects are frequently observed. However, etomidate is known to have hemodynamic and respiratory stability.The purpose of this study was to compare the efficacy and safety of etomidate and propofol in sedated gastric endoscopic submucosal dissection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol | Active comparator | Drug: Propofol Injectioninduction - 0.5mg/kg Propofol maintenance - 0.25mg/kg Propofol |
| Etomidate | Experimental | Drug: Etomidate Injectioninduction - 0.25mg/kg Propofol + 0.05mg/kg Etomidate maintenance - 0.05mg/kg Etomidate |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 19-80
- American Society of Anesthesiologists Physical Status Classification System (ASA) score of I, II, III
- Scheduled endoscopy
Key exclusion criteria (10 listed)
- Pregnancy
- Previous study History of hypersensitivity to drugs or substances containing soy or egg ingredients
- Those who think that tracheal intubation will be difficult
- Obstructive sleep apnea
- History of side effects from previous sedatives
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 InjectionProofol and etomidate are drugs used for sedation and have the same white color. Gastric endoscopic submucosal dissection is performed using propofol in the control group and etomidate in the experimental group. Efficacy and safety of sedatives were confirmed using propofol and etomidate. | Drug | Etomidate |
| Propofol InjectionProofol and etomidate are drugs used for sedation and have the same white color. Gastric endoscopic submucosal dissection is performed using propofol in the control group and etomidate in the experimental group. Efficacy and safety of sedatives were confirmed using propofol and etomidate. | Drug | Propofol |
Primary outcome
Respiratory adverse event
Time frame: during gastric endoscopic submucosal dissection
the number and proportion of cases of respiratory depression
6 secondary outcomes
ESD clinical outcomes
Time frame: From enrollment to the first clinic visit (within 60 days)
Adverse events and procedure interruptions
Time frame: during gastric endoscopic submucosal dissection
Sedation-related profile
Time frame: From initial administering the sedative drug to endoscopy room discharge (up to 2 hours); dose (ml)
Satisfaction assessment
Time frame: From initial administering the sedative drug to endoscopy room discharge; satisfaction score (0-10, 10 is the highest score)
Hemodynamic changes
Time frame: From date of randomization until the date of first documented progression (up to 2 hours)
Factors associated with adverse events
Time frame: From date of randomization until the date of first documented progression (up to three days)
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 12 Nov 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Etomidate Injection and Propofol Injection in people with Sedation Complication and Endoscopic Submucosal Dissection, run by Korea University Anam Hospital at 1 site in South Korea.
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 3 inclusion and 10 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 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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.
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?
Respiratory adverse event (time frame: during gastric endoscopic submucosal dissection). 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 12 Nov 2024.