RemimazolamPhase 4NCT05856617
Remimazolam vs Propofol as an Induction Agent for Morbid Obesity Patients
A Phase 4 study testing Remimazolam besylate in people with Remimazolam and Desflurane, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
It is known that morbidly obese patients are often accompanied by cardiovascular complications such as hypertension, cardiac hypertrophy, and diastolic dysfunction, and are known to increase the risk of hypotension during anesthesia induction. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Remimazolam, Desflurane, Morbid Obesity
- What is being tested?
- Remimazolam besylate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Oct 2022to 12 Sep 2023
- Phase
- Phase 4
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- =or > 20 years
- Admission for General anesthesia for sleeve gastrectomy
Who cannot join
- No severe adverse effect history or hypersensitivity of benzodiazepines or its additives
- Acute alcoholic intoxication state
- Coma or shock state due to other condition than heart problem.
- Acute narrow-angle glaucoma
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul national university Bundang hospital
Seongnam-si, 13620
In-Ae Song, 31-787-7499, nodame1@naver.com
About this study
Official title: Comparison of Remimazolam and Propofol as an Induction Agent for Morbid Obesity Patients Undergoing Laparoscopic Sleeve Gastrectomy
It is known that morbidly obese patients are often accompanied by cardiovascular complications such as hypertension, cardiac hypertrophy, and diastolic dysfunction, and are known to increase the risk of hypotension during anesthesia induction. Remimazolam is widely used in Japan and the United States, and it was approved as a drug for general anesthesia and sedation in Korea in 2021. It was reported that remimazolam caused less hypotension after induction of anesthesia than propofol. However, there is no study on the use of remimazolam in patients undergoing bariatric surgery due to morbid obesity. Therefore, through this study, we plan to check whether remimazolam is safe and effective as an anesthetic-inducing agent for morbidly obese patients undergoing bariatric surgery.
Read the detailed description
According to a report by M.Doi et al., the incidence of hypotension was 20% in the group using remimazolam 6mg/kg/hr as an anesthetic induction dose for surgical patients, which was significantly higher than that of the control group using propofol (49.3%). When the number of subjects was calculated by a two-sided significance test with an alpha error rate of 0.05 and a power of 80% (experimental group 20%, control group 49.3%; chi square), each group required 40 subjects considering the following. With dropout rate of 10%, total of 44 subjects in each group were required.
Among the patients who were admitted to Seoul National University Bundang Hospital and underwent laparoscopic sleeve gastrectomy under general anesthesia, patients who voluntarily signed the consent form after listening to sufficient explanations about this clinical trial and taking sufficient time to make a decision were eligible. The explanation of consent is provided by the medical staff (doctor), such as the principal researcher or co-researcher of this study, and when the consent form is signed, the person is listed as a research subject. There is no separate pre-screening other than taking a medical history for research subject selection.
We will do the modified intention-to-treat group analysis, which means that we will include all cases except for cases that the subject was found major selection criteria were violated after assignment of subject numbers, cases that administration of investigational drugs was not initiated, or cases where major data about efficacy can not be obtained after medication administration initiation in analyses. Additionally we will report excluded cases with the exclusion reasons.
Statistical analysis
- Tested by analyzing the t-test of the mean value test (the Mann-Whitney U test when normality is not satisfied) when normality is satisfied in the case of non-scale according to the scale of the outcome variable In the case of a chi-squared categorical variable (expected frequency is 20 % less than 5 cells and analyzed using Fisher's exact test), or Fisher's exact test (when it is possible).
- If the P value is less than 0.05, it is judged as a significant result.
Handling missing data
- Missing values from this test will not be replaced unless otherwise specified.
- Conditions
- Remimazolam, Desflurane, Morbid Obesity, Sleeve Gastrectomy, General Anesthesia
- Being tested
- Remimazolam besylate
- Keywords
- Remimazolam, Desflurane, Morbid obesity, sleeve gastrectomy
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam besylateDrug
Remimazolam besylate anesthesia induction
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam | Experimental | Anesthesia induction with remimazolam Receives: Drug: Remimazolam besylate |
| Propofol | No intervention | Anesthesia induction with propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of hypotension event
Hypotension event
Measured: During anesthesia induction
Secondary outcomes (2)
Induction time
Induction dose administration~LOC
Measured: During anesthesia induction
Vasopressor (total amount)
Total ephedrine dose
Measured: During anesthesia induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start25 Oct 2022
- Primary completion30 Aug 2023 (estimated)
- Study completion12 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RemimazolamStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In-Ae Song, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05856617
- Sponsor's protocol ID
- B-2208-774-001
- Status last verified
- Aug 2023
- First submitted
- 3 May 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Remimazolam and Propofol as an Induction Agent for Morbid Obesity Patients Undergoing Laparoscopic Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT05856617
- Acronym / sponsor ID
- B-2208-774-001
- Conditions
- Remimazolam, Desflurane, Morbid Obesity, Sleeve Gastrectomy, General Anesthesia
- Keywords
- Remimazolam, Desflurane, Morbid obesity, sleeve gastrectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- 30 Aug 2023 (estimated)
- Study completion
- 12 Sep 2023 (estimated)
- First posted
- 12 May 2023 (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.
It is known that morbidly obese patients are often accompanied by cardiovascular complications such as hypertension, cardiac hypertrophy, and diastolic dysfunction, and are known to increase the risk of hypotension during anesthesia induction. Remimazolam is widely used in Japan and the United States, and it was approved as a drug for general anesthesia and sedation in Korea in 2021. It was reported that remimazolam caused less hypotension after induction of anesthesia than propofol. However, there is no study on the use of remimazolam in patients undergoing bariatric surgery due to morbid obesity. Therefore, through this study, we plan to check whether remimazolam is safe and effective as an anesthetic-inducing agent for morbidly obese patients undergoing bariatric surgery.
Detailed description
According to a report by M.Doi et al., the incidence of hypotension was 20% in the group using remimazolam 6mg/kg/hr as an anesthetic induction dose for surgical patients, which was significantly higher than that of the control group using propofol (49.3%). When the number of subjects was calculated by a two-sided significance test with an alpha error rate of 0.05 and a power of 80% (experimental group 20%, control group 49.3%; chi square), each group required 40 subjects considering the following. With dropout rate of 10%, total of 44 subjects in each group were required.
Among the patients who were admitted to Seoul National University Bundang Hospital and underwent laparoscopic sleeve gastrectomy under general anesthesia, patients who voluntarily signed the consent form after listening to sufficient explanations about this clinical trial and taking sufficient time to make a decision were eligible. The explanation of consent is provided by the medical staff (doctor), such as the principal researcher or co-researcher of this study, and when the consent form is signed, the person is listed as a research subject. There is no separate pre-screening other than taking a medical history for research subject selection.
We will do the modified intention-to-treat group analysis, which means that we will include all cases except for cases that the subject was found major selection criteria were violated after assignment of subject numbers, cases that administration of investigational drugs was not initiated, or cases where major data about efficacy can not be obtained after medication administration initiation in analyses. Additionally we will report excluded cases with the exclusion reasons.
Statistical analysis
- Tested by analyzing the t-test of the mean value test (the Mann-Whitney U test when normality is not satisfied) when normality is satisfied in the case of non-scale according to the scale of the outcome variable In the case of a chi-squared categorical variable (expected frequency is 20 % less than 5 cells and analyzed using Fisher's exact test), or Fisher's exact test (when it is possible).
- If the P value is less than 0.05, it is judged as a significant result.
Handling missing data
- Missing values from this test will not be replaced unless otherwise specified.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remimazolam | Experimental | Drug: Remimazolam besylateAnesthesia induction with remimazolam |
| Propofol | No intervention | –Anesthesia induction with propofol |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- =or > 20 years
- Admission for General anesthesia for sleeve gastrectomy
Key exclusion criteria (4 listed)
- No severe adverse effect history or hypersensitivity of benzodiazepines or its additives
- Acute alcoholic intoxication state
- Coma or shock state due to other condition than heart problem.
- Acute narrow-angle glaucoma
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 |
|---|---|---|
| Remimazolam besylateRemimazolam besylate anesthesia induction | Drug | Remimazolam |
Primary outcome
Rate of hypotension event
Time frame: During anesthesia induction
Hypotension event
2 secondary outcomes
Induction time
Time frame: During anesthesia induction
Vasopressor (total amount)
Time frame: During anesthesia induction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Remimazolam besylate in people with Remimazolam and Desflurane, run by Seoul National University Bundang 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 14 Aug 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact In-Ae Song (31-787-7499, nodame1@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of hypotension event (time frame: During anesthesia induction). 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 14 Aug 2023.