Remimazolam vs Propofol as an Induction Agent for Morbid Obesity Patients
Primary Purpose
Remimazolam, Desflurane, Morbid Obesity
Status
Recruiting
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Remimazolam besylate
Sponsored by
About this trial
This is an interventional treatment trial for Remimazolam focused on measuring Remimazolam, Desflurane, Morbid obesity, sleeve gastrectomy
Eligibility Criteria
Inclusion Criteria: =or > 20 years Admission for General anesthesia for sleeve gastrectomy Exclusion Criteria: 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
Sites / Locations
- Seoul national university Bundang hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Remimazolam
Propofol
Arm Description
Anesthesia induction with remimazolam
Anesthesia induction with propofol
Outcomes
Primary Outcome Measures
Rate of hypotension event
Hypotension event
Secondary Outcome Measures
Induction time
Induction dose administration~LOC
Vasopressor (total amount)
Total ephedrine dose
Full Information
NCT ID
NCT05856617
First Posted
May 3, 2023
Last Updated
August 8, 2023
Sponsor
Seoul National University Bundang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05856617
Brief Title
Remimazolam vs Propofol as an Induction Agent for Morbid Obesity Patients
Official Title
Comparison of Remimazolam and Propofol as an Induction Agent for Morbid Obesity Patients Undergoing Laparoscopic Sleeve Gastrectomy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 25, 2022 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
September 12, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Remimazolam, Desflurane, Morbid Obesity, Sleeve Gastrectomy, General Anesthesia
Keywords
Remimazolam, Desflurane, Morbid obesity, sleeve gastrectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Did not tell them about assigned group till all the measurement ends.
Allocation
Randomized
Enrollment
88 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Remimazolam
Arm Type
Experimental
Arm Description
Anesthesia induction with remimazolam
Arm Title
Propofol
Arm Type
No Intervention
Arm Description
Anesthesia induction with propofol
Intervention Type
Drug
Intervention Name(s)
Remimazolam besylate
Intervention Description
Remimazolam besylate anesthesia induction
Primary Outcome Measure Information:
Title
Rate of hypotension event
Description
Hypotension event
Time Frame
During anesthesia induction
Secondary Outcome Measure Information:
Title
Induction time
Description
Induction dose administration~LOC
Time Frame
During anesthesia induction
Title
Vasopressor (total amount)
Description
Total ephedrine dose
Time Frame
During anesthesia induction
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
=or > 20 years
Admission for General anesthesia for sleeve gastrectomy
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
In-Ae Song
Phone
31-787-7499
Email
nodame1@naver.com
Facility Information:
Facility Name
Seoul national university Bundang hospital
City
Seongnam-si
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
In-Ae Song
Phone
31-787-7499
Email
nodame1@naver.com
12. IPD Sharing Statement
Learn more about this trial
Remimazolam vs Propofol as an Induction Agent for Morbid Obesity Patients
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