Remimazolam vs Propofol as an Induction Agent for Morbid Obesity Patients
Comparison of Remimazolam and Propofol as an Induction Agent for Morbid Obesity Patients Undergoing Laparoscopic Sleeve Gastrectomy
1 other identifier
interventional
88
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2022
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 25, 2022
CompletedFirst Submitted
Initial submission to the registry
May 3, 2023
CompletedFirst Posted
Study publicly available on registry
May 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 12, 2023
CompletedAugust 14, 2023
August 1, 2023
10 months
May 3, 2023
August 8, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of hypotension event
Hypotension event
During anesthesia induction
Secondary Outcomes (2)
Induction time
During anesthesia induction
Vasopressor (total amount)
During anesthesia induction
Study Arms (2)
Remimazolam
EXPERIMENTALAnesthesia induction with remimazolam
Propofol
NO INTERVENTIONAnesthesia induction with propofol
Interventions
Eligibility Criteria
You may qualify if:
- =or \> 20 years
- Admission for General anesthesia for sleeve gastrectomy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul national university Bundang hospital
Seongnam-si, 13620, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Did not tell them about assigned group till all the measurement ends.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
May 3, 2023
First Posted
May 12, 2023
Study Start
October 25, 2022
Primary Completion
August 30, 2023
Study Completion
September 12, 2023
Last Updated
August 14, 2023
Record last verified: 2023-08