Comparing Remimazolam and Propofol for Anesthesia in Obese Patients
Comparison of Remimazolam and Propofol as an Induction Agent for Morbid Obesity Patients Undergoing Laparoscopic Sleeve Gastrectomy
This study is testing whether remimazolam is a safer and more effective anesthetic than propofol for morbidly obese patients having weight loss surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Seoul National University Bundang Hospital Academic / other |
| Locations | 1 site (Seongnam-si) |
| Trial ID | NCT05856617 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and effectiveness of remimazolam as an anesthetic induction agent compared to propofol in morbidly obese patients undergoing laparoscopic sleeve gastrectomy. The study will involve patients admitted to Seoul National University Bundang Hospital who meet specific inclusion criteria and consent to participate. A total of 44 subjects will be enrolled in each group, and the incidence of hypotension during anesthesia induction will be assessed. The trial will utilize a modified intention-to-treat analysis to ensure comprehensive data evaluation.
Who should consider this trial
Good fit: Ideal candidates for this study are morbidly obese patients aged 20 years or older who are scheduled for laparoscopic sleeve gastrectomy under general anesthesia.
Not a fit: Patients with a history of severe adverse reactions to benzodiazepines or those in acute states of intoxication or shock may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer anesthesia practices for morbidly obese patients, reducing the risk of hypotension during surgery.
How similar studies have performed: While remimazolam has shown promise in other surgical contexts, this specific application in morbidly obese patients undergoing bariatric surgery is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seongnam-si
- Seoul national university Bundang hospital — Seongnam-si, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: In-Ae Song
- Email: nodame1@naver.com
- Phone: 31-787-7499
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.